# K982498: Diagnostic Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Volumetrics Medical Imaging, Inc.
- Decided: Aug 7, 1998 after 21 days
- Product code: IYN (System, Imaging, Pulsed Doppler, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1550
- 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 K952551 (1995). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K963863: Janus I, 3D Ultrasound, Inc. (1997) Summary page 3.
- K952551: Janus I, 3D Ultrasound, Inc. (1995) Summary page 3.

## Indications for use
Diagnostic Ultrasound

Source page: https://510kreport.com/device/K982498
Methodology: https://510kreport.com/methodology