SEARCH RESULTS FOR: ios企业签费用-电报ltesign.tsk(458 results)
Care Assist
Philips Medizin Systeme Böblingen GmbH
Care Assist iOS
In Commercial Distribution
- 00884838127432 ()
989803221531
- Centralized patient monitor
No Description
Thought Technology Ltd.
SA4515
In Commercial Distribution
- 07540191000630 ()
- Psychophysiological biofeedback system
Accessories
CeramTec Schweiz GmbH
301291
In Commercial Distribution
- 07640161395015 ()
301291
- Dental implant suprastructure, temporary, preformed, single-use
Eversense NOW Remote Monitoring mobile application (iOS) is intended to be a secondary device used to remotely view an Eversense CGM System user’s glucose information.
SENSEONICS, INCORPORATED
FG-5901-01-300
In Commercial Distribution
- 00817491021267 ()
FG-5901-01-300
- Implantable glucose monitoring system
Navina Smart Transanal Irrigation. Bowel diary APP
Wellspect AB
75750
75750
- Rectal irrigation system application software
A native iOS and Android mobile application also compatible with iPad. It is used to:
• Locate patients according to patient ID
• Locate scheduled procedures by connecting to modality worklist
• Capture videos, images and audio files to be included in the study case.
• Add notes and tags to each file (asset).
• Upload any file to the Orpheus System
• Manually or automatically delete files from the file library
ORPHEUS MEDICAL LTD
01
In Commercial Distribution
- 07290017025100 ()
MLL-EG30001
- Radiology information system application software
Navina Smart Transanal Irrigation. Bowel diary APP
Wellspect AB
75750
Not in Commercial Distribution
- 07392532242373 ()
75750
- Rectal irrigation system application software
No Description
Philips Ultrasound LLC
795160
In Commercial Distribution
- 00884838103399 ()
- Extracorporeal ultrasound imaging transducer, hand-held
No Description
Zhejiang Shuyou Surgical Instrument Co.,Ltd.
VIX-A015腔镜电极
In Commercial Distribution
- 06924274950608 ()
- Open-surgery electrosurgical electrode, monopolar, single-use
The Wavely Middle Ear Fluid Scanner utilizes the WavelyDx Middle Ear Fluid CMD iOS Application, the mobile software, used in conjunction with the Wavely Ear Tip. The Wavely Middle Ear Fluid Scanner turns a smartphone into an acoustic reflectometer, which uses sound waves to accurately detect the presence of middle ear fluid that may
be associated with acute ear infection.
Wavely Diagnostics, Inc.
SWA-1262
In Commercial Distribution
- 00860007953712 ()
SWA-1262
- Impedance audiometer
Accessories
CeramTec Schweiz GmbH
301251
In Commercial Distribution
- 07640161394780 ()
301251
- Dental implant suprastructure, temporary, preformed, single-use
Accessories
CeramTec Schweiz GmbH
301250
In Commercial Distribution
- 07640161394773 ()
301250
- Dental implant suprastructure, temporary, preformed, single-use
Accessories
CeramTec Schweiz GmbH
301249
In Commercial Distribution
- 07640161394766 ()
301249
- Dental implant suprastructure, temporary, preformed, single-use
reSET-O® Mobile Application running on iOS. reSET-O is a prescription-only digital therapy intended to deliver cognitive behavioral therapy (CBT) to patients with opioid use disorder (OUD). The Demo Version provides demonstration access to various prescription versions of the reSET-O product and is not intended for patients.
PEAR THERAPEUTICS, INC.
1
In Commercial Distribution
- 10851580008231 ()
- Mental health/function therapeutic software, screen-viewed
reSET® Mobile Application running on iOS. reSET is a prescription-only digital therapy intended to deliver cognitive behavioral therapy (CBT) to patients with substance use disorder (SUD). The Demo Version provides demonstration access to various prescription versions of the reSET product and is not intended for patients.
PEAR THERAPEUTICS, INC.
1
In Commercial Distribution
- 10851580008200 ()
- Mental health/function therapeutic software, screen-viewed
No Description
STARKEY LABORATORIES, INC.
“ProAkustik name” for iOS
In Commercial Distribution
- 00842318130839 ()
- Audiometric/hearing device software
No Description
STARKEY LABORATORIES, INC.
“KIND name” for iOS
In Commercial Distribution
- 00842318130815 ()
- Audiometric/hearing device software
Software as a medical device (SaMD) for some Lilly medicines which provides access to medication reminders and customer support services; Operates on Apple iOS devices
ELI LILLY AND COMPANY
MA9160 IOS (Version 14)
In Commercial Distribution
- 00300021284558 ()
MA9160001AM
- Medication reminder application software
- Patient subjective symptom recorder
Software as a medical device (SaMD) for some Lilly medicines which provides access to medication reminders and customer support services; Operates on Apple iOS devices
ELI LILLY AND COMPANY
MA9158 IOS (Version 13)
In Commercial Distribution
- 00300021177553 ()
MA9158001AM
- Medication reminder application software
- Patient subjective symptom recorder
Software as a medical device (SaMD) for some Lilly medicines which provides access to medication reminders and customer support services; Operates on Apple iOS devices
ELI LILLY AND COMPANY
MA9140 IOS (Version 12)
In Commercial Distribution
- 00300021175559 ()
MA9140001AM
- Medication reminder application software
- Patient subjective symptom recorder
Software as a medical device (SaMD) for some Lilly medicines which provides access to medication reminders and customer support services; Operates on Apple iOS devices
ELI LILLY AND COMPANY
MA9142 IOS (Version 17)
In Commercial Distribution
- 00300021451554 ()
MA9142001AM
- Medication reminder application software
- Patient subjective symptom recorder
Software as a medical device (SaMD) for some Lilly medicines which provides access to medication reminders and customer support services; Operates on Apple iOS devices
ELI LILLY AND COMPANY
MA9162 IOS (Version 15)
In Commercial Distribution
- 00300021286552 ()
MA9162001AM
- Medication reminder application software
- Patient subjective symptom recorder
Care Assist
Philips Medical Systems Hsg
Care Assist iOS 4.2
In Commercial Distribution
- 00884838123717 ()
989803221531
- Centralized patient monitor
reSET-O® Mobile Application running on iOS. reSET-O is a prescription-only digital therapy intended to deliver cognitive behavioral therapy (CBT) to patients with opioid use disorder (OUD). The Introductory Access Limited Version provides limited access to the reSET-O product.
PEAR THERAPEUTICS, INC.
1
Not in Commercial Distribution
- 10851580008170 ()
- Mental health/function therapeutic software, screen-viewed
reSET® Mobile Application running on iOS. reSET is a prescription-only digital therapy intended to deliver cognitive behavioral therapy (CBT) to patients with substance use disorder (SUD). The Introductory Access Limited Version provides limited access to the reSET product.
PEAR THERAPEUTICS, INC.
1
Not in Commercial Distribution
- 10851580008149 ()
- Mental health/function therapeutic software, screen-viewed
The Glooko Mobile application for iOS and Android displays retrospective data that is captured from BG meters, insulin pumps and continuous glucose monitors (CGM)
GLOOKO, INC.
5.xx
In Commercial Distribution
- 00855093008033 ()
- Clinical management support software
No Description
STARKEY LABORATORIES, INC.
Thrive Hearing Control for iOS
In Commercial Distribution
- 00842318130792 ()
- Audiometric/hearing device software
Dedicated speech generating device utilizing synthesized speech, permitting multiple methods of message formulation and multiple methods of device access based on Apple iOS operating system.
RM SPEECH
RMNXS
In Commercial Distribution
- B660RMNXS0 ()
- Voice synthesizer/digitizer
Dedicated speech generating device utilizing synthesized speech, permitting multiple methods of message formulation and multiple methods of device access based on Apple iOS operating system.
RM SPEECH
RMNXL
In Commercial Distribution
- B660RMNXL0 ()
- Voice synthesizer/digitizer
Dedicated speech generating device utilizing synthesized speech, permitting multiple methods of message formulation and multiple methods of device access based on Apple iOS operating system.
RM SPEECH
RMNS
In Commercial Distribution
- B660RMNS0 ()
- Voice synthesizer/digitizer
Dedicated speech generating device utilizing synthesized speech, permitting multiple methods of message formulation and multiple methods of device access based on Apple iOS operating system.
RM SPEECH
RMN
In Commercial Distribution
- B660RMN0 ()
- Voice synthesizer/digitizer
Glooko Mobile Insulin Dosing System (MIDS) is an insulin dose calculator. The Glooko MIDS Mobile Application is only available to patients who have been prescribed MIDS by their heath care provider. The mobile application can be downloaded by patients from the Google Play Store for Android and from the Apple App Store for iOS operating systems.
GLOOKO, INC.
5.x
In Commercial Distribution
- 00855093008002 ()
- Clinical management support software
RESET-O is an iOS application intended to increase retention of opioid use disorder patients in outpatient treatment by providing cognitive behavioral therapy as an adjunct to outpatient treatment.
Harvest Bio LLC
2.0.2
In Commercial Distribution
- 00850074433019 ()
- Mental health/function therapeutic software, screen-viewed
RESET Mobile Application runs on iOS and is intended to provide cognitive behavioral therapy, as an adjunct to a contingency management system, for patients 18 years of age and older.
Harvest Bio LLC
2.0.2
In Commercial Distribution
- 00850074433002 ()
- Mental health/function therapeutic software, screen-viewed
SC TABLET MINI, SGD, WITH TDSNAP FOR iOS and iPad Mini. Small portable speech device for people who can not speak due to disability, injury or illness. High output speakers, durability and ingress protection for
TOBII DYNAVOX LLC
SC Tablet Mini
In Commercial Distribution
- 07340074601929 ()
113527
- Voice synthesizer/digitizer
Spaulding Client Application is a web based application for trained users of the Spaulding Medical Electrocardiograph device 2100iQ.
The application enables clinicians or trained core personnel who are acting on the orders of a licensed physician to process, display, store, and print diagnostic 12 lead ECGs utilizing an IOS platform.
SPAULDING MEDICAL
1.3.6.1
In Commercial Distribution
- B441SMIOSCLIENTAPP0 ()
SMIOSCLIENTAPP
- Electrocardiographic long-term ambulatory recording analyser application software
iOS application portion for Salux™ Tablet-Controlled Audiometer system. The Examinetics Tablet-Controlled Audiometer is an audiometer designed to be compliant with ANSI Standard 3.6. The Salux™ Audiometer will have the ability to interface with other software necessary for administering hearing screenings. The Salux™ Audiometer solution can be used to display video or static content to the participant.
Examinetics, Inc.
SALUX-SW-02
SALUX-SW-02
- Tone audiometer, semi-automated
iOS application portion for Salux™ Tablet-Controlled Audiometer system. The Examinetics Tablet-Controlled Audiometer is an audiometer designed to be compliant with ANSI Standard 3.6. The Salux™ Audiometer will have the ability to interface with other software necessary for administering hearing screenings. The Salux™ Audiometer solution can be used to display video or static content to the participant.
Examinetics, Inc.
SALUX-SW-01
In Commercial Distribution
- 00860007826627 ()
SALUX-SW-01
- Tone audiometer, semi-automated
Remidio Portable Slit Lamp (PSL-D20) is a handheld digital device for anterior segment screening & diagnosis of the human eye. High-resolution images obtained with advanced optics and using iPhone’s latest technology. User-friendly iOS enhances the imaging technology and the Remidio patient management application enable the user to view, save, archive, edit and retrieve the captured Anterior Images using a built im-age archival database.
REMIDIO INNOVATIVE SOLUTIONS PRIVATE LIMITED
PSL - D20
In Commercial Distribution
- 08906096520045 ()
3231680018
- Ophthalmic examination slit lamp
A native iOS and Android mobile application also compatible with iPad. It is used to:
• Locate patients according to patient ID
• Locate scheduled procedures by connecting to modality worklist
• Capture videos, images and audio files to be included in the study case.
• Add notes and tags to each file (asset).
• Upload any file to the Orpheus System
• Manually or automatically delete files from the file library
ORPHEUS MEDICAL LTD
01
In Commercial Distribution
- 07290017025124 ()
ML-EG30001
- Radiology information system application software
App IOS 2.0.1. This database entry also covers the following minor/medium software updates: v2.0.2: (01)00860001471700(11)190807(10)202; v2.0.3: (01)00860001471700(11)190927(10)203; v2.0.4: (01)00860001471700(11)191014(10)204; v2.0.5: (01)00860001471700(11)191218(10)205; v2.0.6:(01)00860001471700(11)200227(10)206; v2.1.0: (01)00860001471700(11)200528(10)210; v2.2.1: (01)00860001471700(11)200729(10)221; v2.3.0: (01)00860001471700(11)201217(10)230; v2.3.1: (01)00860001471700(11)210205(10)231; v2.3.2: (01)00860001471700(11)210507(10)232
AMPLIFON SPA
2.0.1
In Commercial Distribution
- 00860001471700 ()
- Hearing aid/implant system remote control
reSET-O Mobile Application runs on iOS. reSET-O is intended to increase retention of patients with opioid use disorder (OUD) in outpatient treatment by providing cognitive behavioral therapy, as an adjunct to outpatient treatment that includes transmucosal buprenorphine and contingency management, for patients 18 years or older who are currently under the supervision of a clinician. reSET-O is indicated as a prescription-only Mobile Medical Application.
Limitations of Use: reSET-O has not been shown to decrease illicit drug use or improve abstinence in patients with OUD.
PEAR THERAPEUTICS, INC.
1.1
Not in Commercial Distribution
- 10851580008057 ()
N/A
- Mental health/function therapeutic software, screen-viewed
Soovu Pain Relief System is a kit branded as Soovu Heatwave Therapy and includes two 2" x 2" pods/heaters that, when adhered to user's skin via disposable adhesive rings, provide pulsed heat at controlled temperatures for set therapy durations. The pods are Bluetooth-paired with, and controlled via, a mobile device application (Soovu on iOS or Android) from which the user also administers the heat therapy sessions. The Soovu Heatwave Therapy Kit includes 2 heating pods, 1 dual-pod charging cradle, 1 USB charging cable, 60 'Daily' adhesives, carry case, and Quick Start Guide.
Soovu Labs, Inc.
SL-WPTKIT-01
In Commercial Distribution
- 00850014805005 ()
- Electric pad localized-body heating system
The Spaulding Electrocardiograph Model 2100iQ works with the Spaulding webECG Diagnostic ECG management solution. (Medical Device Data System) The light weight and portable Spaulding Electrocardiograph 2100iQ device* collects and uploads a dedicated patient’s ECG (electrocardiograph) information to the WebECG system and receives a report back from the WebECG system. The Spaulding Electrocardiograph 2100iQ streams ECG heart rhythms data to iOS®, Android™ or Windows® devices using Bluetooth® wireless communication. Using the Spaulding Patient Cable and strategically placed electrodes, it allows the Spaulding Application software (Spaulding ECG) to collect a 12-lead ECG.
SPAULDING MEDICAL
2100iQ
In Commercial Distribution
- B441IQ0 ()
- Electrocardiograph, professional, multichannel
The Spaulding Electrocardiograph Model 2100iQ works with the Spaulding webECG Diagnostic ECG
management solution. (Medical Device Data System) The light weight and portable Spaulding
Electrocardiograph 2100iQ device* collects and uploads a dedicated patient’s ECG (electrocardiograph)
information to the WebECG system and receives a report back from the WebECG system.
The Spaulding Electrocardiograph 2100iQ streams ECG heart rhythms data to iOS®, Android™ or
Windows® devices using Bluetooth® wireless communication. Using the Spaulding Patient Cable and
strategically placed electrodes, it allows the Spaulding Application software (Spaulding ECG) to collect a
12-lead ECG.
SPAULDING MEDICAL
2100iQ
In Commercial Distribution
- B441BTIEC0 ()
- Electrocardiograph, professional, multichannel
The Spaulding Electrocardiograph Model 2100iQ works with the Spaulding webECG Diagnostic ECG
management solution. (Medical Device Data System) The light weight and portable Spaulding
Electrocardiograph 2100iQ device* collects and uploads a dedicated patient’s ECG (electrocardiograph)
information to the WebECG system and receives a report back from the WebECG system.
The Spaulding Electrocardiograph 2100iQ streams ECG heart rhythms data to iOS®, Android™ or
Windows® devices using Bluetooth® wireless communication. Using the Spaulding Patient Cable and
strategically placed electrodes, it allows the Spaulding Application software (Spaulding ECG) to collect a
12-lead ECG.
SPAULDING MEDICAL
2100iQ
In Commercial Distribution
- B441BTAHA0 ()
- Electrocardiograph, professional, multichannel
The ZEISS® Connect App mobile application will be an optional accessory of ZEISS® UNO 3 microscope product. ZEISS® Connect application SW will be available to the end user as an iOS app and user should be able to download and install the same from Apple App store. ZEISS® Connect App will pair wirelessly to the UNO3 variants of microscope and associated peripheral devices (like monitor etc.).
This database entry covers UDI for SW version 2.0 and higher. Version 2.0-> UDI - (01)04049539070135(10)200-> Version 3.0-> UDI - (01)04049539070135(10)301 ->Version 4.2-> UDI - (01)04049539070135(10)420
Carl Zeiss Meditec AG
2.0
In Commercial Distribution
- 04049539070135 ()
- Multidisciplinary medical image management software
reSET Mobile Application runs on iOS. reSET is intended to provide cognitive behavioral therapy, as an adjunct to a contingency management system, for patients 18 years of age and older who are currently enrolled in outpatient treatment under the supervision of a clinician. reSET is indicated as a 12 week (90 days) prescription-only treatment for patients with substance use disorder (SUD), who are not currently on opioid replacement therapy, who do not abuse alcohol solely, or who do not abuse opioids as their primary substance of abuse. It is intended to -
- increase abstinence from a patient’s substances of abuse during treatment, and
- increase retention in the outpatient treatment program.
PEAR THERAPEUTICS, INC.
1.5
Not in Commercial Distribution
- 10851580008026 ()
N/A
- Mental health/function therapeutic software, screen-viewed
The Falcon MD is an interactive medical image display software device for diagnostic image viewing of radiological images for the following modalities: X-ray, CT, MRI, Ultrasound, and XA for iOS and iPadOS platforms. The technological characteristics and the indications of use are identical to those of the Horos MD™ (K232589). The subject device provides both 2D and 3D image visualization tools for CT and MRI scans from various makes and models of image acquisition hardware. It does not produce any original medical images and does not contain controls for the direct operation of a diagnostic imaging system. The device is intended to be operated by radiologists, clinicians and other qualified physicians.
ICAT SOLUTIONS LTD
HOROS MOBILE
In Commercial Distribution
- 05070002336815 ()
- Radiology picture archiving and communication system workstation
Rejoyn (also known as CT-152) is a digital therapeutic smartphone application (app) for the treatment of Major Depressive Disorder (MDD) symptoms. Rejoyn is a prescription smartphone app-based digital therapeutic administered to a user via the user’s smartphone device (running Apple iPhone operating system [iOS®] or Android™ operating system [OS]), which delivers a proprietary interactive cognitive emotional and behavioral therapeutic intervention. The core components of Rejoyn are the Emotional Faces Memory Task (EFMT) exercises, brief cognitive behavioral therapy (CBT)-based lessons to learn and apply key therapeutic skills, and short message service (SMS) text messaging to reinforce CBT-based lesson content and to encourage engagement with the app. It is intended for the treatment of MDD symptoms as an adjunct to clinician-managed outpatient care for adult patients with MDD aged 22 years and older. It is intended to reduce MDD symptoms. Rejoyn is designed for use as an adjunct to clinician-managed outpatient care over a period of 6 weeks for the treatment of MDD symptoms, followed by a 4-week extension period where CBT-based lesson content will be accessible but no new therapeutic content or EFMT exercises will be available. Rejoyn is not intended to be used as a stand-alone therapy or as a substitution for the patient’s clinician prescribed medications.
Otsuka Pharmaceutical Development & Commercialization, Inc.
CT-152
In Commercial Distribution
- 00857335005121 ()
- 57335-0005-12 ()
57335000512
- Mental health/function therapeutic software, screen-viewed