# K991858: Ssa-390A/Power Vision 8000

- Pathway: 510(k) (Traditional)
- Applicant: Toshiba America Medical Systems, In.C
- Decided: Jun 16, 1999 after 15 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: 3 generations back to K894632 (1989). 13 ancestors in all.
212 later devices descend from it; 1 cites it directly.
0 of 226 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K933743: SSA-380A, Toshiba America Medical Systems, In.C (1994) Summary page 1.
- K943303: PVK-357AT, Toshiba America Medical Systems, In.C (1995) Summary page 1.
- K963705: Color Enhancement Function for the Ssa-380A, Toshiba America Medical Systems, In.C (1996) Summary page 1.
- K970047: Phased Array Transducer - - PSK-20CT, Toshiba America Medical Systems, In.C (1997) Summary page 1.
- K981397: Harmonic Imaging and Flash Echo Imaging Function for the Diagnostic Ultrasound System Ssa-380A, Powervision 7000, Toshiba America Medical Systems, In.C (1998) Summary page 1.

## Cited in the summary but kept off the family tree
- K964805: Bio-Anchor, Linvatec Corp. (1997). Our OCR of the scanned summary read K964805, FDA’s number for Bio-Anchor (Linvatec Corp.). Its FDA name has none of the distinctive words the summary uses for the device it names, “SSA-380A/PowerVision 7000”. Kept off the family tree. Summary page 1.

## Most influential descendants
- 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
- K072000: Aplio XG Diagnostic Ultrasound System, Model Ssa-790A Version 2.0 (2007), 203 descendants of its own

## Indications for use
The PowerVision 8000 is intended to be used for the following type of studies; fetal, abdominal, intraoperative, pediatric, small organs, neonatal cephalic, adult cephalic, cardiac, transrectal, transvaginal, transesophageal, peripheral vascular, and musculo-skeletal (both conventional and superficial).

Source page: https://510kreport.com/device/K991858
Methodology: https://510kreport.com/methodology