# K974880: Perception GPS-RST Diagnostic Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Perception, Inc.
- Decided: Jun 8, 1998 after 160 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: 3 generations back to K921750 (1992). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K963616: Aloka SSD-1700 Diagnostic Ultrasound System, Aloka Co., Ltd. (1997) Summary page 1.
- K935024: ESI-5000, Elscint, Inc. (1996) Summary page 1.
- K924079: CFM-800 Color Flow Mapping System, Diasonics, Inc. (1993) Summary page 1.
- K962662: Vingmed Sound Color Flow Mapping System, Diasonics, Inc. (1997) Summary page 1.
- K972973: Perception Inc. GPS-Tuv Diagnostic Ultrasound System, Perception, Inc. (1997) Summary page 1.

## Indications for use
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Source page: https://510kreport.com/device/K974880
Methodology: https://510kreport.com/methodology