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MY TSF HOMECARE APP ANDROID
Smith & Nephew, Inc.
71075403
In Commercial Distribution
- 00885556808016 ()
71075403
- Wireless patient monitor/sensor reporting software, layperson-use
MY TSF HOMECARE APP iOS
Smith & Nephew, Inc.
71075402
In Commercial Distribution
- 00885556746387 ()
71075402
- Wireless patient monitor/sensor reporting software, layperson-use
SMART TSF.COM
Smith & Nephew, Inc.
71075401
In Commercial Distribution
- 00885556746370 ()
71075401
- External orthopaedic fixation frame calculation software
No Description
ICU MEDICAL, INC.
22-0004-0206-25
In Commercial Distribution
- 15019517225471 ()
- Configurable electronic form web-based application software
No Description
ICU MEDICAL, INC.
22-0117-0201-25
In Commercial Distribution
- 15019517157888 ()
- Infusion pump medication-dosage application software
No Description
ICU MEDICAL, INC.
22-0004-0204-25
In Commercial Distribution
- 15019517157871 ()
- Infusion pump medication-dosage application software
SENSOR
BECTON, DICKINSON AND COMPANY
516700
In Commercial Distribution
- 00382905167003 ()
- 50382905167008 ()
516700
- Intravenous line sensor, anaesthesia injection
CADDIE is cloud based artificial intelligence medical device software. CADDIE interfaces with the video feed generated by an endoscopic video processor during a colonoscopy procedure.
The software is intended to be used by trained and qualified healthcare professionals as an accompaniment to video endoscopy for the purpose of drawing attention to regions with visual characteristics consistent with colonic mucosal lesions (such as polyps and adenomas).
CADDIE analyses the data from the endoscopic video processor in real-time and provides information to aid the endoscopist in detecting suspected colorectal polyps, if they are in the field of view of the endoscope.
The areas highlighted by CADDIE are not to be interpreted as definite polyps or adenomas. The responsibility to make a decision as to whether or not a highlighted region contains a polyp or is an adenoma lies with the user. The endoscopist is responsible for reviewing CADDIE suspected polyp areas and confirming the presence or absence of a polyp and its classification based on their own medical judgement.
ODIN MEDICAL LIMITED
v1.4.x
In Commercial Distribution
- 15065010840024 ()
- Endoscopic video image interpretive software
Software, Version 11.0, CyberKnife
(Operating Software group for CyberKnife Treatment Delivery System)
ACCURAY INCORPORATED
1055810
In Commercial Distribution
- M6581055810 ()
NA
- Linear accelerator system
IQ HOLTER PLUG-IN SOFTWARE v10.0.6: New Software Release for Midmark Digital Holter.
MIDMARK CORPORATION
P/N 4-100-3140
In Commercial Distribution
- 00841709118067 ()
- Electrocardiographic long-term ambulatory recording analyser
Software, CyberKnife Version 11.1 (Software group that operates CyberKnife Treatment Delivery System)
ACCURAY INCORPORATED
1061945
In Commercial Distribution
- 00811376030023 ()
NA
- Linear accelerator system
MapRT is used to assist treatment planning whereby the patient surface and positioning devices captured at simulation can be modelled against the treatment devices, such that any potential collisions can be predicted.
VISION RT LIMITED
MapRT acquisition software
In Commercial Distribution
- 05056190500757 ()
MapRT
- Radiation therapy software
AlignRT 7.3 (software) used on AlignRT Plus systems
VISION RT LIMITED
AlignRT 7.3 (software)
In Commercial Distribution
- 05056190500726 ()
AlignRT 7.3 (software)
- Radiological video camera patient positioning/tracking system
No Description
VIEWRAY INCORPORATED
A3i
In Commercial Distribution
- 00850036816027 ()
- Linear accelerator system
- Stereotactic teletherapy radionuclide system, MRI-imaging
No Description
ORAMETRIX, INC.
7.6
In Commercial Distribution
- 00856379007085 ()
- CAD/CAM software
Earlens Fitting Software. Lot Number is for manufacturing packaging of software. Version is in Application Identifier (8012).
EARLENS CORPORATION
ELF003
In Commercial Distribution
- 00850013007417 ()
ELF003
- Audiometric/hearing device software
The Eko Analysis Software is intended to provide support to the physician in the evaluation of patients' heart sounds
and ECG’s. The software analyzes simultaneous ECG and heart sounds. The software will detect the presence of
suspected murmurs in the heart sounds. The software also detects the presence of atrial fibrillation and normal
sinus rhythm from the ECG signal. In addition, it calculates certain cardiac time intervals such as heart rate, QRS
duration and EMAT. The software does not distinguish between different kinds of murmurs and does not identify
other arrhythmias.
It is not intended as a sole means of diagnosis. The interpretations of heart sounds and ECG offered by the software
are only significant when used in conjunction with physician over-read and is for use on adults (> 18 years)
Eko Devices, Inc.
EAS
In Commercial Distribution
- 00850010298030 ()
- Cardiopulmonary physiological parameter analysis software
No Description
KONICA MINOLTA, INC.
AEVM
In Commercial Distribution
- 04560141951433 ()
- Basic diagnostic x-ray system application software
SFW 9735911 STEALTH S8 STEREOTAXY
MEDTRONIC NAVIGATION, INC.
9735911
In Commercial Distribution
- 00643169878211 ()
- Neurological stereotactic surgery system
SFW 9735910 STEALTH S8 DBS
MEDTRONIC NAVIGATION, INC.
9735910
In Commercial Distribution
- 00643169878204 ()
- Neurological stereotactic surgery system
SW APP 9735762 STEALTH S8 APP
MEDTRONIC NAVIGATION, INC.
9735762
In Commercial Distribution
- 00643169865341 ()
- Multi-purpose stereotactic surgery system
SFW KIT 9735916 S8 CRANIAL PLAN STATION
MEDTRONIC NAVIGATION, INC.
9735916
In Commercial Distribution
- 00643169931329 ()
- Neurological stereotactic surgery system
SFW KIT 9735921 S8 DBS STEREOTX
MEDTRONIC NAVIGATION, INC.
9735921
In Commercial Distribution
- 00643169921917 ()
- Neurological stereotactic surgery system
SFW KIT 9735739 STEALTH S8 STEREOTX
MEDTRONIC NAVIGATION, INC.
9735739
In Commercial Distribution
- 00643169838987 ()
- Neurological stereotactic surgery system
SFW KIT 9735738 STEALTH S8 CRN DBS
MEDTRONIC NAVIGATION, INC.
9735738
In Commercial Distribution
- 00643169838970 ()
- Neurological stereotactic surgery system
SW KIT 9735737 STEALTH S8 CRANIAL
MEDTRONIC NAVIGATION, INC.
9735737
In Commercial Distribution
- 00643169838963 ()
- Neurological stereotactic surgery system
No Description
Omniscient Neurotechnology Pty Ltd (o8t)
2.1
In Commercial Distribution
- 09358140000055 ()
SCI0006
- Radiological PACS software
Animal
DEXIS LLC
9
In Commercial Distribution
- EKAV101034090 ()
PLU235
- Radiology information system application software
Forensic
DEXIS LLC
9
In Commercial Distribution
- EKAV101034080 ()
PLU236
- Radiology information system application software
Enterprise
DEXIS LLC
9
In Commercial Distribution
- EKAV101034120 ()
PLU238
- Radiology information system application software
US & International
DEXIS LLC
9
In Commercial Distribution
- EKAV101034110 ()
PLU349
- Radiology information system application software
The NAVIS-EX image filing software is software that acquires data from the following NIDEK fundus photography devices and files it for easy transfer to external systems. NAVIS-EX is equipped with functions for image acquiring, image display, image drawing, image processing, image measurement, panorama image creation, stereo image observation, composite image creation, and Follow-Up. (According to the image, available functions are limited.) Image data can be transferred by network or e-mail. NAVIS-EX can construct a network among multiple terminals and refers to and edits data from the client
PC.
NIDEK CO.,LTD.
NAVIS-EX
In Commercial Distribution
- 04987669100523 ()
- Eye anterior segment analyser software
- Posterior eye segment analyser software
No Description
CANON MEDICAL SYSTEMS CORPORATION
VSTP-002A
In Commercial Distribution
- 04987670105005 ()
- Radiological PACS software
No Description
OLYMPUS MEDICAL SYSTEMS CORP.
MAJ-2188
In Commercial Distribution
- 14953170373760 ()
- 04953170373763 ()
N5400340
- Video capsule endoscopy system application software
No Description
KEELER LIMITED
3020-P-5079
In Commercial Distribution
- 05055272715744 ()
- Ophthalmic examination slit lamp
System Software for NeuroStar Mobile Console
NEURONETICS, INC.
Version 3.7
In Commercial Distribution
- 00850005944508 ()
83-00054-000
- Magnetic neural stimulation system
System Software for NeuroStar Mobile Console
NEURONETICS, INC.
Version 3.8
In Commercial Distribution
- 00850005944355 ()
83-00093-000
- Magnetic neural stimulation system
System Software for NeuroStar Mobile Console
NEURONETICS, INC.
Version 3.6
In Commercial Distribution
- 00850005944119 ()
83-00054-000
- Magnetic neural stimulation system
System Software for NeuroStar Mobile Console
NEURONETICS, INC.
Version 3.5
In Commercial Distribution
- 00850005944089 ()
83-00054-000
- Magnetic neural stimulation system
ShuntCheck software - Installed on Windows computer; guides user through test procedure, gathers and analyzes thermal data, presents results screen with Flow Confirmed or Flow Not Confirmed plus a time-temperature graph
NEURODX DEVELOPMENT LLC
SCIII SW
In Commercial Distribution
- 00865435000311 ()
SCIII SW
- Heater/cooler system tester kit
a calculator/data processing module for clinical use described as electronic device intended to store, retrieve, and process laboratory data.
ASSOCIATES OF CAPE COD, INC.
0
In Commercial Distribution
- 00862696000289 ()
- Laboratory instrument/analyser application software IVD
VMA DataLink Software (SW4) available to customers on Ortho Kinematics secure site
ORTHO KINEMATICS, INC.
3
In Commercial Distribution
- 00868579000223 ()
- Radiological PACS software
No Description
ORTHO KINEMATICS, INC.
2.3
In Commercial Distribution
- 00868579000216 ()
- Radiological PACS software
No Description
Virtual Vision Health
3.2.0
In Commercial Distribution
- 00860010709795 ()
VV-021
- Perimeter, automatic
No Description
Virtual Vision Health
3.1.0
In Commercial Distribution
- 00860010709788 ()
- Perimeter, automatic
No Description
Virtual Vision Health
3.0.0
In Commercial Distribution
- 00860010709757 ()
- Perimeter, automatic
No Description
Virtual Vision Health
2.7.0
In Commercial Distribution
- 00860010709740 ()
- Perimeter, automatic
No Description
Virtual Vision Health
2.6.0
In Commercial Distribution
- 00860010709733 ()
- Perimeter, automatic
D-Scope Systems server software enables data and media synchronization features within the client's medical facilities by integrating with the client information system and patient EMR (HL7) and PACS/VNA (DICOM).
D-Scope Systems
6
In Commercial Distribution
- 00860009377615 ()
- Endoscopic video image processing unit
D-Scope Systems workstation software is a hardware-agnostic application for HD-quality medical video and image recording in clinical and OR settings. The user interface allows capture, marking, storage and sharing of files that has integration capability with patient EMR (HL7) and PACS/VNA (DICOM).
The application and its browser allow access to a secure space within the client's network that facilitates remote and local file review, referrals and consultations with a HIPAA conformant logon authorization.
Intended functions include medical process automation: procedural steps, population of patient demographic data, and management of active medical media from scheduling through discharge.
D-Scope Systems
6
In Commercial Distribution
- 00860009377608 ()
- Endoscopic video image processing unit