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Software to be used in GI Genius™ systems.
LINKVERSE SRL
4.0.1
In Commercial Distribution
- 78055060110344 ()
- 08055060110345 ()
CPRO401-US
- Endoscopic video image interpretive software
No Description
LINKVERSE SRL
CPRO40.US
In Commercial Distribution
- 78055060110290 ()
- 08055060110291 ()
- Endoscopic video image interpretive software
Ibex Prostate Detect is a software only device intended to analyze scanned histopathology whole slide images (WSIs) from prostate core needle biopsies (PCNB) prepared from hematoxylin & eosin (H&E) stained formalin-fixed paraffin embedded (FFPE) tissue. The device is intended to identify cases initially diagnosed as benign for further review by a pathologist. If Ibex Prostate Detect detects tissue morphology suspicious for prostate adenocarcinoma (AdC), it provides case- and slide-level alerts (flags) which includes a heatmap of tissue areas in the WSI that is likely to contain cancer.
Ibex Prostate Detect is intended to be used with slide images digitized with Philips Ultra Fast Scanner and visualized using the Ibex Prostate Detect user interface.
Ibex Prostate Detect outputs are not intended to be used on a standalone basis for diagnosis, to rule out prostatic AdC or to preclude pathological assessment of WSIs according to the standard of care.
IBEX MEDICAL ANALYTICS LTD
3.1-US
In Commercial Distribution
- 07290019124016 ()
- Histology/cytology/microbiology image-analysis interpretive software IVD
No Description
Chengdu Wision Medical Device Co., Ltd.
WIPD01
In Commercial Distribution
- 06973770840012 ()
- Endoscopic video image interpretive software
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
Smartphone stethoscope software application with AI for iPhones - Rx only
Sparrow Acoustics Inc.
3.x.x
In Commercial Distribution
- 00860011561729 ()
- Electronic acoustic stethoscope
Liquichek Reticulocyte Control (A-I) Bilevel MiniPak (An assayed reticulocyte control.)
BIO-RAD LABORATORIES, INC.
915X
In Commercial Distribution
- 00847661003793 ()
915X
- Reticulocyte count IVD, control
Liquichek Reticulocyte Control (A-I) Level 2 (An assayed reticulocyte control.)
BIO-RAD LABORATORIES, INC.
917
In Commercial Distribution
- 00847661003786 ()
917
- Reticulocyte count IVD, control
Liquichek Reticulocyte Control (A-I) Level 1 (An assayed reticulocyte control.)
BIO-RAD LABORATORIES, INC.
916
In Commercial Distribution
- 00847661003779 ()
916
- Reticulocyte count IVD, control
Calibration of apolipoprotein A-I and B assays on BN Systems
Siemens Healthcare Diagnostics Products GmbH
10446466
In Commercial Distribution
- 00842768011535 ()
- 00842768018602 ()
OUPG09
- Plasma protein IVD, calibrator