# K962662: Vingmed Sound Color Flow Mapping System

- Pathway: 510(k) (Traditional)
- Applicant: Diasonics, Inc.
- Decided: Jan 2, 1997 after 178 days
- Product code: IYO (System, Imaging, Pulsed Echo, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1560
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K921750 (1992). 1 ancestor in all.
3 later devices descend from it; 3 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K921750: Cvis Insight Iii System, Cardiovascular Imaging Systems, Inc. (1992) Summary page 1.

## Most influential descendants
- K972973: Perception Inc. GPS-Tuv Diagnostic Ultrasound System (1997), 2 descendants of its own
- K981834: Perception Inc, GPS-6TBMD Diagnostic Ultrasound System (1998), 0 descendants of its own
- K974880: Perception GPS-RST Diagnostic Ultrasound System (1998), 0 descendants of its own

## Indications for use
The IVUS option for the CFM product family is intended for intravascular applications at all system control settings. When used with a Vingmed Color Flow Mapping (CFM) imaging system the device can be used to obtain, store and retrieve 2D images and perform measurements and analysis on these. The IVUS option is intended for use by duly licensed physician who has received appropriate training in proper operation of the device. As with any procedure of this sort, the physician conducting the examination must exercise sound medical judgment in the selection of patients for this product, and be skilled in interpreting the echocardiographic data obtained from intra-vascular ultrasound devices. The IVUS option is intended to be used with a Vingmed Color Flow Mapping (CFM) imaging system to apply ultrasound energy from an intra-vascular catheter to: Produce 2D images that can be used to detect abnormalities. Store images in the CFM system or via the CFM system to other storage media. Images can be retrieved from the CFM system or storage media for measurement and analysis.

Source page: https://510kreport.com/device/K962662
Methodology: https://510kreport.com/methodology