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No Description
B. J. ZH. F. Panther Medical Equipment Co., Ltd.
FCSLWBE26
In Commercial Distribution
- 06939282418569 ()
- Intraluminal circular stapler, single-use
StrokeSENS LVO is a radiological computer-aided triage and notification (CADt) software indicated for use in the analysis of CTA head images. The device is intended to assist hospital networks and trained clinicians in workflow triage by flagging and communication of suspected positive findings of Large Vessel Occlusion (L VO) in head CTA images.
StrokeSENS LVO uses a software algorithm to identify suspected LVO findings. In the case of a suspected L VO, the system will send a notification to a pre-configured destination(s), notifying the clinicians of the existence of a suspected LVO that requires review. The notification system is intended to be used in parallel to the standard of care workflow to notify clinicians of the existence of the case earlier that they may have been notified as part of the standard of care workflow.
Notifications may include a compressed preview of images. Notifications are meant for informational purposes only and are not intended for diagnostic use beyond notification. The StrokeSENS LVO device does not alter the original medical image and is not intended to be used as a diagnostic device.
The results of StrokeSENS LVO are intended to be used in conjunction with other patient information and based on professional judgement, to assist with triage/ prioritization of medical images. Notified clinicians are responsible for viewing full images per standard of care.
Circle Cardiovascular Imaging Inc
v2.x
- CT system application software
No Description
Circle Cardiovascular Imaging Inc
3.x
In Commercial Distribution
- 00882916000530 ()
- CT system application software
No Description
Circle Cardiovascular Imaging Inc
2.1
In Commercial Distribution
- 00882916000523 ()
- CT system application software
No Description
Circle Cardiovascular Imaging Inc
1.x
In Commercial Distribution
- 00882916000516 ()
v1.x and v2.0
- CT system application software
FREE SPIRIT
MEDACURE INC.
FS660
In Commercial Distribution
- 00853223008014 ()
- Freestanding patient lifting system, electrically-powered
No Description
Icad, Inc.
2.1
In Commercial Distribution
- 00858012005960 ()
- Basic diagnostic x-ray system application software
No Description
Icad, Inc.
V2
Not in Commercial Distribution
- 00858012005939 ()
- Basic diagnostic x-ray system application software
"PowerLook Density Assessment 3.4 is a software application intended for use with DBT 2D images from tomosynthesis exams. PowerLook Density Assessment 3.4 provides a BI-RADS 5th Edition breast density category to aid health care professionals in the assessment of breast tissue composition. PowerLook Density Assessment 3.4 produces adjunctive information. It is not a diagnostic aid.
Icad, Inc.
V3.4
In Commercial Distribution
- 00858012005922 ()
D70141, D70142, D70160
- Basic diagnostic x-ray system application software
VeraLook® CTC CAD Software is intended to automatically detect potential polyps in CT Colonography exams. The identified polyps can then be highlighted to the interpreting physician after initial review of the CTC exam with the intent of identifying additional potential polyps that may not have been identified on initial review.
Icad, Inc.
V1.1
In Commercial Distribution
- 00858012005915 ()
CT-102
- CT system application software