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Philips IntelliSpace Clinical Applications is an image processing workstation software package designed to run on standard PC hardware. The hardware required is made up of "off-the-shelf" standard computer components. Philips IntelliSpace Clinical Applications software receives image data from medical scanning devices, such as CT and MRI, or from image archives. Philips IntelliSpace Clinical Applications performs viewing, image manipulation, communication, printing, and quantification of images.
Philips Medical Systems Nederland B.V.
8.x
In Commercial Distribution
- 00884838074804 ()
837509
- Radiology picture archiving and communication system workstation
I4 (Integrated Intelligent Imaging Informatics) system is a software package used with general purpose computing hardware to acquire, store, distribute, process and display images and associated data throughout a clinical environment. The software performs digital image processing, measurement, image manipulation, communication and storage. I4 (Integrated Intelligent Imaging Informatics) is offering a primary interpretation solution for reviewing and analysing a large variety of medical images deriving from various imaging modalities as well as non-imaging information. I4 integrates with clinical imaging and non-imaging data sources to present in addition to images non-imaging data in patient context.
Philips Medical Systems Nederland B.V.
1.x
In Commercial Distribution
- 00884838074743 ()
- Radiology picture archiving and communication system workstation
IntelliSpace Portal is a software medical device that allows multiple users to remotely access clinical applications from compatible computers on a network. The system allows networking, selection, processing, archiving and filming of multimodality DICOM images. This software is for use with off-the-shelf hardware technology that meets defined minimum specifications.
Philips Medical Systems Nederland B.V.
8.x
Not in Commercial Distribution
- 00884838073876 ()
- Radiology DICOM image processing application software
The Enterprise Viewer is used for image distribution within the enterprise. It is used by clinicians as the primary user interface to view and interact with images. It is also used by Radiologists as a lightweight form to access images where they don’t have access to the complete diagnostic workstations. Enterprise Viewer is accessed through an HTML5 browser either over a desktop or using a capable mobile device.
Philips Medical Systems Nederland B.V.
15.X
In Commercial Distribution
- 00884838107595 ()
839064
- Radiological PACS software
- Radiology picture archiving and communication system workstation
The Web Diagnostic Viewer is the radiologist diagnostic workstation including the clinical applications (implemented using Web technology) with similar functionality as the Desktop Diagnostic Viewer workstation.
Philips Medical Systems Nederland B.V.
15.X
In Commercial Distribution
- 00884838107588 ()
839063
- Radiological PACS software
- Radiology picture archiving and communication system workstation
The Desktop Diagnostic Viewer is the end user’s primary user interface used to interact with clinical images. It includes the clinical applications.
Philips Medical Systems Nederland B.V.
15.X
In Commercial Distribution
- 00884838107571 ()
839062
- Radiological PACS software
- Radiology picture archiving and communication system workstation
Image Management is intended to provide complete and scalable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve, process and display medical images and data from hospital medical imaging and information systems.
The device contains clinical applications that assist the processing, analyzing and comparing of medical images. It is a single device that integrates the review, dictation and reporting tools to create a productive work environment for the radiologists and physicians.
Philips Medical Systems Nederland B.V.
15.X
In Commercial Distribution
- 00884838107557 ()
839060
- Radiological PACS software
- Radiology picture archiving and communication system workstation
No Description
Philips Electronics Nederland B.V.
1.1.X
Not in Commercial Distribution
- 00884838098244 ()
821401000000
- Cognitive assessment software
illumeo system is a software package used with general purpose computing hardware to acquire, store, distribute, process and display images and associated data throughout a clinical environment. The software performs digital image processing, measurement, image manipulation, communication and storage. illumeo is offering a primary interpretation solution for reviewing and analysing a large variety of medical images deriving from various imaging modalities as well as non-imaging information. illumeo integrates with clinical imaging and non-imaging data sources to present in addition to images non-imaging data in patient context.
Philips Medical Systems Nederland B.V.
v2.x
In Commercial Distribution
- 00884838087958 ()
45980141116X
- Radiology picture archiving and communication system workstation
No Description
Budget Hearing Aids, LLC
Atom X
In Commercial Distribution
- 00850065060880 ()
- Air-conduction hearing aid, canal
No Description
Bausch & Lomb GmbH
E3839 X
In Commercial Distribution
- 04058935011659 ()
- Suturing needle holder, reusable
No Description
Bausch & Lomb GmbH
E3305 X
In Commercial Distribution
- 04058935012045 ()
- Corneal scissors, reusable
The Welldoc® App for Diabetes in Pregnancy and Insulin Pump Users (the software) is Software as a Medical Device (SaMD) intended to be used by patients – aged 18 years and older – who have type 1, type 2 diabetes, or gestational diabetes - who are also pregnant or use an insulin pump.
The software is intended to help people with diabetes manage their health in their daily environment. The software, running on a mobile phone, collects health data, promotes healthy behavior, and encourages adherence to treatment plans and self-monitoring practices as advised by a healthcare provider. The software also generates
electronic reports intended for a healthcare provider.
The software provides secure transfer, storage, and secondary display of data from devices such as continuous glucose monitors (CGM), blood glucose meters, blood pressure monitors, activity trackers, and weight scales as well as self-reported health information. When receiving CGM data, the software also serves as a secondary CGM alarm system, providing alerts to enable immediate awareness of conditions that may require clinical intervention. The software also performs retrospective analysis of CGM data which may be used by people with diabetes and their healthcare provider when determining therapeutic strategies.
The software provides educational content to encourage behaviors which may help living well with diabetes based on guidance from healthcare professional organizations. This may include promoting healthy lifestyle choices such as getting enough sleep, eating a balanced diet, maintaining a healthy weight, and promoting physical activity.
The software is not intended to replace the care provided by a licensed healthcare professional, including prescriptions, diagnosis, or treatment nor is it intended to replace self-monitoring practices as advised by a physician. The software does not provide treatment recommendations.
WELLDOC, INC.
3.X
Not in Commercial Distribution
- B553202258OTC0 ()
- Self-care monitoring/reporting software
The Welldoc® App for Diabetes in Pregnancy and Insulin Pump Users (the software) is Software as a Medical Device (SaMD) intended to be used by patients – aged 18 years and older – who have type 1, type 2 diabetes, or gestational diabetes - who are also pregnant or use an insulin pump.
The software is intended to help people with diabetes manage their health in their daily environment. The software, running on a mobile phone, collects health data, promotes healthy behavior, and encourages adherence to treatment plans and self-monitoring practices as advised by a healthcare provider. The software also generates
electronic reports intended for a healthcare provider.
The software provides secure transfer, storage, and secondary display of data from devices such as continuous glucose monitors (CGM), blood glucose meters, blood pressure monitors, activity trackers, and weight scales as well as self-reported health information. When receiving CGM data, the software also serves as a secondary CGM alarm system, providing alerts to enable immediate awareness of conditions that may require clinical intervention. The software also performs retrospective analysis of CGM data which may be used by people with diabetes and their healthcare provider when determining therapeutic strategies.
The software provides educational content to encourage behaviors which may help living well with diabetes based on guidance from healthcare professional organizations. This may include promoting healthy lifestyle choices such as getting enough sleep, eating a balanced diet, maintaining a healthy weight, and promoting physical activity.
The software is not intended to replace the care provided by a licensed healthcare professional, including prescriptions, diagnosis, or treatment nor is it intended to replace self-monitoring practices as advised by a physician. The software does not provide treatment recommendations.
WELLDOC, INC.
3.X
Not in Commercial Distribution
- B553202257OTC0 ()
- Self-care monitoring/reporting software
Welldoc Diabetes is indicated for use by healthcare providers (HCPs) and their patients – aged 18 years and older - who have type 1 or type 2 diabetes. Welldoc Diabetes is intended to provide secure capture, storage, and transmission of blood glucose data as well as information to aid in diabetes self-management. Welldoc Diabetes analyzes and reports blood glucose test results and supports medication adherence. In addition, Welldoc Diabetes provides coaching messages (motivational, behavioral, and educational) based on real-time blood glucose values and trends. It includes software intended for use on mobile phones or personal computers in the home or in professional healthcare settings. The software also allows for entry of other diabetes-related healthcare information and provides educational information.
Welldoc Diabetes is not intended to replace the care provided by a licensed healthcare professional, including prescriptions, diagnosis, or treatment.
Welldoc also includes other functions that are designed to maintain, encourage a healthy lifestyle or help users manage their disease or condition without providing specific treatment or treatment suggestions.
WELLDOC, INC.
3.X
Not in Commercial Distribution
- B553202256RX0 ()
- Home pharmaceutical management support software
Welldoc Diabetes is indicated for use by healthcare providers (HCPs) and their patients – aged 18 years and older - who have type 1 or type 2 diabetes. Welldoc Diabetes is intended to provide secure capture, storage, and transmission of blood glucose data as well as information to aid in diabetes self-management. Welldoc Diabetes analyzes and reports blood glucose test results and supports medication adherence. In addition, Welldoc Diabetes provides coaching messages (motivational, behavioral, and educational) based on real-time blood glucose values and trends. It includes software intended for use on mobile phones or personal computers in the home or in professional healthcare settings. The software also allows for entry of other diabetes-related healthcare information and provides educational information.
Welldoc Diabetes is not intended to replace the care provided by a licensed healthcare professional, including prescriptions, diagnosis, or treatment.
Welldoc also includes other functions that are designed to maintain, encourage a healthy lifestyle or help users manage their disease or condition without providing specific treatment or treatment suggestions.
WELLDOC, INC.
3.X
Not in Commercial Distribution
- B553202254RX0 ()
- Home pharmaceutical management support software
Welldoc Diabetes is indicated for use by healthcare providers (HCPs) and their patients – aged 18 years and older - who have type 1 or type 2 diabetes. Welldoc Diabetes is intended to provide secure capture, storage, and transmission of blood glucose data as well as information to aid in diabetes self-management. Welldoc Diabetes analyzes and reports blood glucose test results and supports medication adherence. In addition, Welldoc Diabetes provides coaching messages (motivational, behavioral, and educational) based on real-time blood glucose values and trends. It includes software intended for use on mobile phones or personal computers in the home or in professional healthcare settings. The software also allows for entry of other diabetes-related healthcare information and provides educational information.
Welldoc Diabetes is not intended to replace the care provided by a licensed healthcare professional, including prescriptions, diagnosis, or treatment.
Welldoc also includes other functions that are designed to maintain, encourage a healthy lifestyle or help users manage their disease or condition without providing specific treatment or treatment suggestions.
WELLDOC, INC.
3.X
Not in Commercial Distribution
- B553202253OTC0 ()
- Home pharmaceutical management support software
Welldoc Diabetes is indicated for use by healthcare providers (HCPs) and their patients – aged 18 years and older - who have type 1 or type 2 diabetes. Welldoc Diabetes is intended to provide secure capture, storage, and transmission of blood glucose data as well as information to aid in diabetes self-management. Welldoc Diabetes analyzes and reports blood glucose test results and supports medication adherence. In addition, Welldoc Diabetes provides coaching messages (motivational, behavioral, and educational) based on real-time blood glucose values and trends. It includes software intended for use on mobile phones or personal computers in the home or in professional healthcare settings. The software also allows for entry of other diabetes-related healthcare information and provides educational information.
Welldoc Diabetes is not intended to replace the care provided by a licensed healthcare professional, including prescriptions, diagnosis, or treatment.
Welldoc also includes other functions that are designed to maintain, encourage a healthy lifestyle or help users manage their disease or condition without providing specific treatment or treatment suggestions.
WELLDOC, INC.
3.X
Not in Commercial Distribution
- B553202252RX0 ()
- Home pharmaceutical management support software
Welldoc Diabetes is indicated for use by healthcare providers (HCPs) and their patients – aged 18 years and older - who have type 1 or type 2 diabetes. Welldoc Diabetes is intended to provide secure capture, storage, and transmission of blood glucose data as well as information to aid in diabetes self-management. Welldoc Diabetes analyzes and reports blood glucose test results and supports medication adherence. In addition, Welldoc Diabetes provides coaching messages (motivational, behavioral, and educational) based on real-time blood glucose values and trends. It includes software intended for use on mobile phones or personal computers in the home or in professional healthcare settings. The software also allows for entry of other diabetes-related healthcare information and provides educational information.
Welldoc Diabetes is not intended to replace the care provided by a licensed healthcare professional, including prescriptions, diagnosis, or treatment.
Welldoc also includes other functions that are designed to maintain, encourage a healthy lifestyle or help users manage their disease or condition without providing specific treatment or treatment suggestions.
WELLDOC, INC.
3.X
Not in Commercial Distribution
- B553202251OTC0 ()
- Home pharmaceutical management support software
DEVICE IDENTIFIER, MAIN ASSY, X SERIES ADVANCED MONITOR/DEFIBRILLATOR, 12 LEAD W/INTERP, PACE, NO VOICE, ETCO2, NIBP, BVM, IBP, NIBP, SPO2, SPCO, SPMET (RAINBOW/MASIMO), CPR EXPANSION PACK, MOBILE STREAMING, GERMAN
Zoll Medical Corporation
630-2241712-08
In Commercial Distribution
- 00847946049959 ()
- 8.9" x 10.4" x 8.75"
- Physiologic-monitoring defibrillation system
“X” Osteotome, 7mm
SYMMETRY MEDICAL INC.
10-008-400
In Commercial Distribution
- 00847538006360 ()
2709-01-010
- Orthopaedic osteotome
“X” Osteotome, 7mm
SYMMETRY MEDICAL INC.
10-008-000
In Commercial Distribution
- 00847538001235 ()
00-9986-010-17;00-9986-010-17
- Orthopaedic osteotome
No Description
ASAHI INTECC CO., LTD.
AIN-CKX-10-200-R
In Commercial Distribution
- 04547327120432 ()
- 04547327140324 ()
- Outer Diameter: 0.01 Inch
- Length: 200 Centimeter
- Cardiac/peripheral vascular guidewire, single-use
The FCR CARBON X (CR-IR 357) is equipment designed to read X-ray image information recorded on an imaging plate (IP).
FUJIFILM CORPORATION
CR-IR 357
In Commercial Distribution
- 04547410265903 ()
- Computed radiography digital imaging scanner
PLASMABLADE X PS200-040 4.0 PINK
MEDTRONIC NAVIGATION, INC.
PS200-040
In Commercial Distribution
- 00643169936638 ()
- Open-surgery electrosurgical handpiece/electrode, monopolar, single-use
VasScan Table X, H-F-T, 2D
MEDICAL POSITIONING, INC.
284
In Commercial Distribution
- 00848871001111 ()
- Multi-purpose diagnostic imaging table
VasScan Table X, H-F-T, 0D
MEDICAL POSITIONING, INC.
084
In Commercial Distribution
- 00848871001074 ()
- Multi-purpose diagnostic imaging table
VasScan X, H-T-F-, ARMDROP
MEDICAL POSITIONING, INC.
984
In Commercial Distribution
- 00848871001487 ()
- Multi-purpose diagnostic imaging table
No Description
Dental Savings Club Inc
MISTER-X-R#1
In Commercial Distribution
- D9021050013 ()
- Dental digital imaging sensor, intraoral
MinerOss X Syringe 250µ-1000µ (0.5cc)
ACE SURGICAL SUPPLY CO., INC.
BH0053
In Commercial Distribution
- 00614950028047 ()
BH0053
- Dental bone matrix implant, animal-derived
MinerOss X Syringe 250µ-1000µ (0.25cc)
ACE SURGICAL SUPPLY CO., INC.
BH0052
In Commercial Distribution
- 00614950028030 ()
BH0052
- Dental bone matrix implant, animal-derived
MinerOss X Cancellous LP 1000µm-2000µm (2.0g/6.8cc)
ACE SURGICAL SUPPLY CO., INC.
BH0047
In Commercial Distribution
- 00614950028023 ()
BH0047
- Dental bone matrix implant, animal-derived
MinerOss X Cancellous LP 1000µm-2000µm (1.0g/3.4cc)
ACE SURGICAL SUPPLY CO., INC.
BH0046
In Commercial Distribution
- 00614950028016 ()
BH0046
- Dental bone matrix implant, animal-derived
MinerOss X Cancellous LP 1000µm-2000µm (.05g/1.7cc)
ACE SURGICAL SUPPLY CO., INC.
BH0045
In Commercial Distribution
- 00614950028009 ()
BH0045
- Dental bone matrix implant, animal-derived
MinerOss X Cancellous LP 1000µm-2000µm (0.25g/0.9cc)
ACE SURGICAL SUPPLY CO., INC.
BH0044
In Commercial Distribution
- 00614950027996 ()
BH0044
- Dental bone matrix implant, animal-derived
MinerOss X Cancellous 250µ-1000µ (2.0g/4.7cc)
ACE SURGICAL SUPPLY CO., INC.
BH0039
In Commercial Distribution
- 00614950027989 ()
BH0039
- Dental bone matrix implant, animal-derived
MinerOss X Cancellous 250µ-1000µ (1.0g/2.4cc)
ACE SURGICAL SUPPLY CO., INC.
BH0038
In Commercial Distribution
- 00614950027972 ()
BH0038
- Dental bone matrix implant, animal-derived
MinerOss X Cancellous 250µ-1000µ (.5g/1.2cc)
ACE SURGICAL SUPPLY CO., INC.
BH0037
In Commercial Distribution
- 00614950027965 ()
BH0037
- Dental bone matrix implant, animal-derived
MinerOss X Cancellous 250µ-1000µ (.25g/.6cc)
ACE SURGICAL SUPPLY CO., INC.
BH0036
In Commercial Distribution
- 00614950027958 ()
BH0036
- Dental bone matrix implant, animal-derived
MinerOss X Plug Tapered 9X15MM 5/BOX
ACE SURGICAL SUPPLY CO., INC.
BH0035
In Commercial Distribution
- 10614950027948 ()
- 00614950027941 ()
BH0035
- Dental bone matrix implant, animal-derived