510(k) · Cleared

Cleared

Ssa-370A/Powervision 6000

K991710510(k) TraditionalCleared Jun 3, 199915-day reviewClass II21 CFR 892.1560

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Toshiba America Medical Systems, In.C · IYO System, Imaging, Pulsed Echo, Ultrasonic

Cleared on Jun 3, 1999 as substantially equivalent to K933743 (Toshiba America Medical Systems, In.C, 1994) and 5 other predicates after a 15-day review. Its family tree reaches back 3 generations to 1989. 3 of the 219 devices in its family, counting itself, have a Class I recall. 203 later devices descend from it.

Decided: Jun 3, 1999
Review: 15 days
Class: Class II
Product code: IYO
Recalls: None
Predicates: 6

Its longest line of descent runs back 3 generations to K894632 (1989). 15 ancestors in all, the oldest K891453 (1989). 203 later devices descend from it, 2 citing it directly. 3 of the 219 devices in this family, counting this one, have a Class I recall.

By dateBy generation

Root · 3 generations backK894632 Model SSH-140A Ultrasound Imaging SystemToshiba America Medical Systems, In.C · 1989
2 generations backK941593 Diagnostic Ultrasonic TransducerToshiba America Medical Systems, In.C · 1996
1 generation backK970047 Phased Array Transducer - - PSK-20CTToshiba America Medical Systems, In.C · 1997
This deviceK991710 Ssa-370A/Powervision 6000Toshiba America Medical Systems, In.C · 1999
Descendant · cites it directly · 196 of its ownK994096 Sonoheart Hand-Carried Echocardiography SystemSonosite,Inc. · 1999
Descendant · 2 generations on · 135 of its ownK063761 Acuson P10 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2007
Descendant · 3 generations on · 130 of its ownK092756 GE Vscan Compact Diagnostic Ultrasound SystemGe Vingmed Ultrasound AS · 2009
Descendant · 3 generations on · 107 of its ownK090505 Speq Ultrasound SystemSignostics Pty, Ltd. · 2009
Descendant · 4 generations on · 103 of its ownK102153 Mobius Ultrasound Imaging SystemMobisante, Inc. · 2011

Showing 5 of 203 descendants. See all descendants

Descendants cleared per year

1999high 25 (2025) · low 0 (2000)2026

Class I recalls in this family

K193517 ViziShot 2 FLEX7 generations on · 2020
K242670 Lumify Diagnostic Ultrasound System9 generations on · 2025
K242519 Lumify Diagnostic Ultrasound System9 generations on · 2025

Most influential descendants

Showing 5 of 203 · See all

K994096Sonoheart Hand-Carried Echocardiography SystemSonosite,Inc. · 1999 · cites it directly196descendants
K063761Acuson P10 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2007 · 2 generations on135descendants
K092756GE Vscan Compact Diagnostic Ultrasound SystemGe Vingmed Ultrasound AS · 2009 · 3 generations on130descendants
K090505Speq Ultrasound SystemSignostics Pty, Ltd. · 2009 · 3 generations on107descendants
K102153Mobius Ultrasound Imaging SystemMobisante, Inc. · 2011 · 4 generations on103descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K894632	Model SSH-140A Ultrasound Imaging System	Toshiba America Medical Systems, In.C	1989	—
−2	K941593	Diagnostic Ultrasonic Transducer	Toshiba America Medical Systems, In.C	1996	—
−1	K970047	Phased Array Transducer - - PSK-20CT	Toshiba America Medical Systems, In.C	1997	—
0 (this device)	K991710	Ssa-370A/Powervision 6000	Toshiba America Medical Systems, In.C	1999	—
+1	K994096	Sonoheart Hand-Carried Echocardiography System	Sonosite,Inc.	1999	—
+2	K063761	Acuson P10 Diagnostic Ultrasound System	Siemens Medical Solutions USA, Inc.	2007	—
+3	K092756	GE Vscan Compact Diagnostic Ultrasound System	Ge Vingmed Ultrasound AS	2009	—
+3	K090505	Speq Ultrasound System	Signostics Pty, Ltd.	2009	—
+4	K102153	Mobius Ultrasound Imaging System	Mobisante, Inc.	2011	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1989	1	0
1993	1	0
1994	3	0
1995	1	0
1996	1	0
1997	4	0
1998	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1999	1	0
2001	1	0
2003	1	0
2004	1	0
2005	2	0
2007	4	0
2008	1	0
2009	6	0
2010	1	0
2011	1	0
2012	4	0
2013	2	0
2014	8	0
2015	8	0
2016	11	0
2017	10	0
2018	12	0
2019	12	0
2020	18	1
2021	15	0
2022	15	0
2023	13	0
2024	12	0
2025	25	2
2026	19	0

FIG. 1 — Lineage of K991710, 1989–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

3 devices in this family have a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new IYO device

#1 K243937 Accuro 3Sscore 20.5 · 18 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

Get a 510(k) Report

What was it cleared against? (6)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K933743	SSA-380A Summary page 1 …on of I"redicate Devices: Toshiba America Medical Systems believes that this device is substantially equivalent to the SSA-380A/PowerVision 7000, 510(k) control numbers K933743,K943303, K963705, K964865,K970047, K981397 Device Description: The PowerVision 6000 Ultrasound System is a mobile system. This…	Toshiba America Medical Systems, In.C	1994	—
*	K943303	PVK-357AT Summary page 1 …redicate Devices: Toshiba America Medical Systems believes that this device is substantially equivalent to the SSA-380A/PowerVision 7000, 510(k) control numbers K933743,K943303, K963705, K964865,K970047, K981397 Device Description: The PowerVision 6000 Ultrasound System is a mobile system. This system i…	Toshiba America Medical Systems, In.C	1995	—
*	K963705	Color Enhancement Function for the Ssa-380A Summary page 1 …Devices: Toshiba America Medical Systems believes that this device is substantially equivalent to the SSA-380A/PowerVision 7000, 510(k) control numbers K933743,K943303, K963705, K964865,K970047, K981397 Device Description: The PowerVision 6000 Ultrasound System is a mobile system. This system is a Track…	Toshiba America Medical Systems, In.C	1996	—
*	K964865	PVK-720ST Endocavitary Transducer Summary page 1 …Toshiba America Medical Systems believes that this device is substantially equivalent to the SSA-380A/PowerVision 7000, 510(k) control numbers K933743,K943303, K963705, K964865,K970047, K981397 Device Description: The PowerVision 6000 Ultrasound System is a mobile system. This system is a Track 3 device…	Toshiba America Medical Systems, In.C	1997	—
*	K970047	Phased Array Transducer - - PSK-20CT Summary page 1 …America Medical Systems believes that this device is substantially equivalent to the SSA-380A/PowerVision 7000, 510(k) control numbers K933743,K943303, K963705, K964865,K970047, K981397 Device Description: The PowerVision 6000 Ultrasound System is a mobile system. This system is a Track 3 device that em…	Toshiba America Medical Systems, In.C	1997	—
*	K981397	Harmonic Imaging and Flash Echo Imaging Function for the Diagnostic Ultrasound System… Summary page 1 …Medical Systems believes that this device is substantially equivalent to the SSA-380A/PowerVision 7000, 510(k) control numbers K933743,K943303, K963705, K964865,K970047, K981397 Device Description: The PowerVision 6000 Ultrasound System is a mobile system. This system is a Track 3 device that employs a w…	Toshiba America Medical Systems, In.C	1998	—

Also cleared against K933743: 6 other devices →

What descends from it? (203)

See all 203

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K994096	Sonoheart Hand-Carried Echocardiography System	Sonosite,Inc.	1999	196
K051334	Terason Ultrasound System with Continuous Wave Soppler	Teratech Corp.	2005	5

Has anything in its family been recalled? (3 Class I)

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

K193517ViziShot 2 FLEXOlympus Surgical Technologies America · 2020 · 7 generations on · ◆ in the 2020 descendants bar of FIG. 11 Class I recall
K242670Lumify Diagnostic Ultrasound SystemPhilips Ultrasound · 2025 · 9 generations on · ◆ in the 2025 descendants bar of FIG. 11 Class I recall
K242519Lumify Diagnostic Ultrasound SystemPhilips Ultrasound · 2025 · 9 generations on · ◆ in the 2025 descendants bar of FIG. 11 Class I recall

What does this lineage say?

The line of descent spans 10 years and passes through 1 company; a new generation was cleared every 2.2 years on median.
None of the 15 ancestors has a recall.
Of its descendants, K994096 (Sonosite,Inc., 1999) has gone furthest, with 196 descendants of its own.
6 other devices also cite its predicate K933743.

How does its category compare?

All IYO devices

IYO System, Imaging, Pulsed Echo, Ultrasonic: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · IYO

7in 2025

2007high 20 (2007) · low 5 (2022)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · IYO

171in 2025

2007high 220 (2024) · low 17 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · IYO

1in 2022

2007high 11 (2021) · low 0 (2011)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · IYO

485in 2025

2007high 640 (2024) · low 20 (2008)2025

MAUDE reports naming product code IYO, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	20	17	4	39
2008	14	36	5	20
2009	13	79	9	27
2010	15	113	8	20
2011	11	69	0	58
2012	15	68	2	78
2013	17	50	3	436
2014	14	63	2	304
2015	19	46	1	268
2016	10	36	0	254
2017	19	72	0	238
2018	14	56	1	368
2019	13	59	1	537
2020	11	57	0	498
2021	15	64	11	617
2022	5	190	1	511
2023	11	177	0	527
2024	10	220	0	640
2025	7	171	0	485
2026	10	139	1	—

What is it indicated for?

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).

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K991710 · printed Nov 6, 2026

Cite this page

510(k) Report. “K991710: Ssa-370A/Powervision 6000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K991710

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026