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iLet Bionic Pancreas (Pharmacy Starter Kit)
Beta Bionics, Inc.
Insulin Only
In Commercial Distribution
- 00850050080022 ()
BB1004
- Ambulatory insulin infusion pump/interstitial glucose monitoring system
No Description
THE MAGSTIM COMPANY LIMITED
6251-00
In Commercial Distribution
- 05060229533081 ()
- Clinical management support software
No Description
THE MAGSTIM COMPANY LIMITED
6261-00
In Commercial Distribution
- 05060229533074 ()
- Clinical management support software
No Description
THE MAGSTIM COMPANY LIMITED
5736-00
In Commercial Distribution
- 05060229532794 ()
- Clinical management support software
No Description
THE MAGSTIM COMPANY LIMITED
5453-00
In Commercial Distribution
- 05060229532725 ()
- Clinical management support software
Localization and characterization of thyroid ultrasound images.
SEE-MODE TECHNOLOGIES PTE. LTD.
See-Mode Augmented Reporting Tool, Thyroid (SMART-T)
In Commercial Distribution
- 00860006305727 ()
- Ultrasound imaging system application software
Analysis and reporting of vascular ultrasound images
SEE-MODE TECHNOLOGIES PTE. LTD.
AVA (Augmented Vascular Analysis)
In Commercial Distribution
- 00860006305703 ()
- Ultrasound imaging system application software
MediScout® is an augmented reality accessory to clinical ultrasound (US) systems, with the ability to holographically display the US image for the user as well as provide procedural annotation and a teleprodecural function for remote practitioner collaboration.
Mediview Xr, Inc.
MS-100-1001
In Commercial Distribution
- 00860006066307 ()
- Ultrasound imaging system application software
Concentriq AP-Dx is a diagnostic software device for viewing and managing digital pathology slides from FFPE tissue. It aids pathologists in reviewing and interpreting digital slide images for primary diagnosis, specifically with Hamamatsu NanoZoomer S360MD scanner and JVC monitor. The software requires qualified pathologists to ensure image quality and interpretation validity. Not intended for frozen sections, cytology, or non-FFPE hematopathology specimens.
Proscia Inc.
DX040US
In Commercial Distribution
- 00860006054595 ()
4.8.1
- Laboratory instrument/analyser application software IVD
Concentriq® AP-Dx is a software only device intended for viewing and management of digital images
of scanned surgical pathology slides prepared from formalin-fixed paraffin embedded (FFPE) tissue. It is
an aid to the pathologist to review, interpret and manage these digital slide images for the purpose of
primary diagnosis. Concentriq AP-Dx is not intended for use with frozen sections, cytology, or non-FFPE
hematopathology specimens.
Proscia Inc.
4.6
In Commercial Distribution
- 00860006054557 ()
US
- Laboratory instrument/analyser application software IVD
Concentriq AP-Dx is a web-based, software-only device that is intended to aid pathology professionals in viewing, interpretation and management of digital whole slide images (WSI) of scanned surgical pathology slides prepared from formalin-fixed, paraffin-embedded (FFPE) tissue obtained from Hamamatsu NanoZoomer S360MD Slide scanner. It aids the pathologist in the review, interpretation, and management of pathology slide digital images used to generate a primary diagnosis.
Proscia Inc.
4.5
In Commercial Distribution
- 00860006054519 ()
US
- Laboratory instrument/analyser application software IVD
No Description
EXACT SCIENCES CORPORATION
1.1
In Commercial Distribution
- 00858637005901 ()
- Laboratory instrument/analyser application software IVD
No Description
EXACT SCIENCES CORPORATION
1.7
In Commercial Distribution
- 00858637005888 ()
- Laboratory instrument/analyser application software IVD
No Description
EXACT SCIENCES CORPORATION
1.6
Not in Commercial Distribution
- 00858637005826 ()
- Laboratory instrument/analyser application software IVD
No Description
EXACT SCIENCES CORPORATION
2.1
In Commercial Distribution
- 00858637005413 ()
- Laboratory instrument/analyser application software IVD
No Description
EXACT SCIENCES CORPORATION
2.1
In Commercial Distribution
- 00858637005406 ()
- Laboratory instrument/analyser application software IVD
No Description
EXACT SCIENCES CORPORATION
2.1
In Commercial Distribution
- 00858637005390 ()
- Laboratory instrument/analyser application software IVD
No Description
EXACT SCIENCES CORPORATION
1.4
Not in Commercial Distribution
- 00858637005352 ()
- Laboratory instrument/analyser application software IVD
No Description
EXACT SCIENCES CORPORATION
2.1
In Commercial Distribution
- 00858637005321 ()
- Laboratory instrument/analyser application software IVD
No Description
CAPTION HEALTH, INC.
Alastor
Not in Commercial Distribution
- 00860003586341 ()
- Ultrasound imaging system application software