# K993761: Cardiovascular Measurement System - View

- Pathway: 510(k) (Traditional)
- Applicant: Medis Medical Imaging Systems BV
- Decided: Dec 28, 1999 after 50 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K896095 (1990). 4 ancestors in all.
6 later devices descend from it; 2 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K982862: Radworks Medical Imaging Software with Quality Control Module, Applicare Medical Imaging, B.V. (1998) Summary page 1.
- K962699: Radworks Medical Imaging Software, Applicare Medical Imaging, B.V. (1996) Summary page 1.

## Most influential descendants
- K112807: X-Ray Vva (2012), 2 descendants of its own
- K034059: Sectra Angiography Package and Sectra Cardiology Package (2004), 2 descendants of its own
- K222036: MPXA-2000 (2023), 1 descendant of its own
- K042781: Ipacs Cardio (2004), 1 descendant of its own
- K252634: Imagine® Enterprise Suite (2026), 0 descendants of its own

## Indications for use
CMS-View provides a means for the playback and/or review of medical images or imaging sequences by physicians, scientists or other medical personnel. These medical images may origiftace from different imaging modalities (x-ray, MR, ultrasound, nuclear, etc.) and are input to the CMS-VIEW system via industry standard formats (DICOM) or by creating a digital equivalent of a video-format (via frame-grabber). Standard image review tools are provided, including zoom, brightness and contrast controls. The review of medical images is suitable for use by physicians and scientists in the following applications: 1. Scientific and research studies, selecting and asséssing medical images that are of interest, 2. Review and analysis of patient medical images, providing physicians and administrators with convenient access and review features/capabilities.

Source page: https://510kreport.com/device/K993761
Methodology: https://510kreport.com/methodology
