# K981397: Harmonic Imaging and Flash Echo Imaging Function for the Diagnostic Ultrasound System Ssa-380A, Powervision 7000

- Pathway: 510(k) (Traditional)
- Applicant: Toshiba America Medical Systems, In.C
- Decided: Jul 31, 1998 after 105 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: 2 generations back to K934041 (1994). 7 ancestors in all.
403 later devices descend from it; 2 cite it directly.
3 of 411 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K964309: Sonos 2000, Sonos 2500 (M2406 a), Hewlett-Packard Co. (1997) Summary page 1.
- K961459: Level 10 Hdi, Advanced Technology Laboratories, Inc. (1997) Summary page 1.
- K963315: Vingmed Sound Color Flow Mapping System.  System Five, Vingmed Sound, Inc. (1997) Summary page 1.
- K933473: Catheterization C-Arm Support MH-51BM/MH-51CM, Shimadzu Corp. (1993) Summary page 1.
- K943303: PVK-357AT, Toshiba America Medical Systems, In.C (1995) Summary page 1.

## Most influential descendants
- K991858: Ssa-390A/Power Vision 8000 (1999), 212 descendants of its own
- K013633: Ssa-770A, Aplio Ultrasound System (2001), 211 descendants of its own
- K022400: Ssa-700A, Aplio Diagnostic Ultrasound System (2002), 210 descendants of its own
- K032281: Ssa-770A - Version 4, Aplio Diagnostic Ultrasound System (2003), 209 descendants of its own
- K063130: Aplio XG Diagnostic Ultrasound System, Model Ssa-790A, Version 1.0 (2006), 205 descendants of its own

Source page: https://510kreport.com/device/K981397
Methodology: https://510kreport.com/methodology