# K991710: Ssa-370A/Powervision 6000

- Pathway: 510(k) (Traditional)
- Applicant: Toshiba America Medical Systems, In.C
- Decided: Jun 3, 1999 after 15 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 K894632 (1989). 15 ancestors in all.
203 later devices descend from it; 2 cite it directly.
3 of 219 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.
- K964865: PVK-720ST Endocavitary Transducer, Toshiba America Medical Systems, In.C (1997) 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.

## Most influential descendants
- K994096: Sonoheart Hand-Carried Echocardiography System (1999), 196 descendants of its own
- K063761: Acuson P10 Diagnostic Ultrasound System (2007), 135 descendants of its own
- K092756: GE Vscan Compact Diagnostic Ultrasound System (2009), 130 descendants of its own
- K090505: Speq Ultrasound System (2009), 107 descendants of its own
- K102153: Mobius Ultrasound Imaging System (2011), 103 descendants of its own

## Indications for use
The PowerVision 6000 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/K991710
Methodology: https://510kreport.com/methodology