510(k) · Cleared

Cleared

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

K981397510(k) TraditionalCleared Jul 31, 1998105-day reviewClass II21 CFR 892.1550

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 · IYN System, Imaging, Pulsed Doppler, Ultrasonic

Cleared on Jul 31, 1998 as substantially equivalent to K964309 (Hewlett-Packard Co., 1997) and 4 other predicates after a 105-day review. Its family tree reaches back 2 generations to 1994. 3 of the 411 devices in its family, counting itself, have a Class I recall. 403 later devices descend from it.

Decided: Jul 31, 1998
Review: 105 days
Class: Class II
Product code: IYN
Recalls: None
Predicates: 5

Its longest line of descent runs back 2 generations to K934041 (1994). 7 ancestors in all, the oldest K933473 (1993). 403 later devices descend from it, 2 citing it directly. 3 of the 411 devices in this family, counting this one, have a Class I recall.

By dateBy generation

Root · 2 generations backK934041 Hewlett Packard Conos Ultrasound Imaging System ModificationHewlett-Packard Co. · 1994
1 generation backK964309 Sonos 2000, Sonos 2500 (M2406 a)Hewlett-Packard Co. · 1997
This deviceK981397 Harmonic Imaging and Flash Echo Imaging Function for the Diagnostic…Toshiba America Medical Systems, In.C · 1998
Descendant · cites it directly · 212 of its ownK991858 Ssa-390A/Power Vision 8000Toshiba America Medical Systems, In.C · 1999
Descendant · 2 generations on · 211 of its ownK013633 Ssa-770A, Aplio Ultrasound SystemToshiba America Medical Systems, In.C · 2001
Descendant · 3 generations on · 210 of its ownK022400 Ssa-700A, Aplio Diagnostic Ultrasound SystemToshiba America Medical Systems, In.C · 2002 · Recalled
Descendant · 3 generations on · 209 of its ownK032281 Ssa-770A - Version 4, Aplio Diagnostic Ultrasound SystemToshiba America Medical Systems, In.C · 2003
Descendant · 4 generations on · 205 of its ownK063130 Aplio XG Diagnostic Ultrasound System, Model Ssa-790A, Version 1.0Toshibamedical Systems Corporation · 2006 · Recalled

Showing 5 of 403 descendants. See all descendants

Descendants cleared per year

1999high 48 (2025) · low 0 (2000)2026

Class I recalls in this family

K193517 ViziShot 2 FLEX8 generations on · 2020
K242670 Lumify Diagnostic Ultrasound System10 generations on · 2025
K242519 Lumify Diagnostic Ultrasound System10 generations on · 2025

Most influential descendants

Showing 5 of 403 · See all

K991858Ssa-390A/Power Vision 8000Toshiba America Medical Systems, In.C · 1999 · cites it directly212descendants
K013633Ssa-770A, Aplio Ultrasound SystemToshiba America Medical Systems, In.C · 2001 · 2 generations on211descendants
K022400Ssa-700A, Aplio Diagnostic Ultrasound SystemToshiba America Medical Systems, In.C · 2002 · 3 generations on210descendants
K032281Ssa-770A - Version 4, Aplio Diagnostic Ultrasound SystemToshiba America Medical Systems, In.C · 2003 · 3 generations on209descendants
K063130Aplio XG Diagnostic Ultrasound System, Model Ssa-790A, Version 1.0Toshibamedical Systems Corporation · 2006 · 4 generations on205descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K934041	Hewlett Packard Conos Ultrasound Imaging System Modification	Hewlett-Packard Co.	1994	—
−1	K964309	Sonos 2000, Sonos 2500 (M2406 a)	Hewlett-Packard Co.	1997	—
0 (this device)	K981397	Harmonic Imaging and Flash Echo Imaging Function for the Diagnostic Ultrasound…	Toshiba America Medical Systems, In.C	1998	—
+1	K991858	Ssa-390A/Power Vision 8000	Toshiba America Medical Systems, In.C	1999	—
+2	K013633	Ssa-770A, Aplio Ultrasound System	Toshiba America Medical Systems, In.C	2001	—
+3	K022400	Ssa-700A, Aplio Diagnostic Ultrasound System	Toshiba America Medical Systems, In.C	2002	1
+3	K032281	Ssa-770A - Version 4, Aplio Diagnostic Ultrasound System	Toshiba America Medical Systems, In.C	2003	—
+4	K063130	Aplio XG Diagnostic Ultrasound System, Model Ssa-790A, Version 1.0	Toshibamedical Systems Corporation	2006	1

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1993	1	0
1994	1	0
1995	1	0
1997	2	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1999	3	0
2001	2	0
2002	1	0
2003	2	0
2004	2	0
2005	4	0
2006	1	0
2007	7	0
2008	6	0
2009	11	0
2010	2	0
2011	5	0
2012	12	0
2013	6	0
2014	18	0
2015	13	0
2016	18	0
2017	22	0
2018	28	0
2019	18	0
2020	35	1
2021	24	0
2022	28	0
2023	30	0
2024	25	0
2025	48	2
2026	32	0

FIG. 1 — Lineage of K981397, 1994–2026Source: 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 IYN device

#1 K240850 EPIQ Series Diagnostic Ultrasound Systems…score 32.1 · 24 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? (5)

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
*	K964309	Sonos 2000, Sonos 2500 (M2406 a) Summary page 1 …dentification of Predicate Devices: Toshiba America Medical Systems believes that the SSA-380A PowerVision 7000 is substantially equivalent to: 1) HP Sonos 2500 510(k) K964309 found to be SE on April 22, 1997 2) ATL Level 10 HDI 510k) K961459 found to SE on March 26,1997 3) Diasonics/Vingmed System 5 510…	Hewlett-Packard Co.	1997	—
*	K961459	Level 10 Hdi Summary page 1 …believes that the SSA-380A PowerVision 7000 is substantially equivalent to: 1) HP Sonos 2500 510(k) K964309 found to be SE on April 22, 1997 2) ATL Level 10 HDI 510k) K961459 found to SE on March 26,1997 3) Diasonics/Vingmed System 5 510(k) K963315 found to be SE on March 17, 1997 4) Toshiba SSA-380A P…	Advanced Technology Laboratories, Inc.	1997	—
*	K963315	Vingmed Sound Color Flow Mapping System. System Five Summary page 1 …to: 1) HP Sonos 2500 510(k) K964309 found to be SE on April 22, 1997 2) ATL Level 10 HDI 510k) K961459 found to SE on March 26,1997 3) Diasonics/Vingmed System 5 510(k) K963315 found to be SE on March 17, 1997 4) Toshiba SSA-380A PowerVision 510(k)s K933473 & K943303 Device Description: Functionality:…	Vingmed Sound, Inc.	1997	—
*	K933473	Catheterization C-Arm Support MH-51BM/MH-51CM Summary page 1 …10 HDI 510k) K961459 found to SE on March 26,1997 3) Diasonics/Vingmed System 5 510(k) K963315 found to be SE on March 17, 1997 4) Toshiba SSA-380A PowerVision 510(k)s K933473 & K943303 Device Description: Functionality: This modification will allow the existing SSA-380A system to transmit at one frequ…	Shimadzu Corp.	1993	—
*	K943303	PVK-357AT Summary page 1 …0k) K961459 found to SE on March 26,1997 3) Diasonics/Vingmed System 5 510(k) K963315 found to be SE on March 17, 1997 4) Toshiba SSA-380A PowerVision 510(k)s K933473 & K943303 Device Description: Functionality: This modification will allow the existing SSA-380A system to transmit at one frequency and r…	Toshiba America Medical Systems, In.C	1995	—

Also cleared against K964309: 3 other devices →

What descends from it? (403)

See all 403

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

Number	Device	Applicant	Decided	Descendants
K991858	Ssa-390A/Power Vision 8000	Toshiba America Medical Systems, In.C	1999	212
K991710	Ssa-370A/Powervision 6000	Toshiba America Medical Systems, In.C	1999	203

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 · 8 generations on · ◆ in the 2020 descendants bar of FIG. 11 Class I recall
K242670Lumify Diagnostic Ultrasound SystemPhilips Ultrasound · 2025 · 10 generations on · ◆ in the 2025 descendants bar of FIG. 11 Class I recall
K242519Lumify Diagnostic Ultrasound SystemPhilips Ultrasound · 2025 · 10 generations on · ◆ in the 2025 descendants bar of FIG. 11 Class I recall

What does this lineage say?

The line of descent spans 4 years and passes through 2 companies; a new generation was cleared every 2.6 years on median.
None of the 7 ancestors has a recall.
Of its descendants, K991858 (Toshiba America Medical Systems, In.C, 1999) has gone furthest, with 212 descendants of its own.
3 other devices also cite its predicate K964309.

How does its category compare?

All IYN devices

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

FDA decisions per year · IYN

57in 2025

2007high 64 (2017) · low 13 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · IYN

124in 2025

2007high 124 (2025) · low 18 (2008)2026

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

Recalls per year · IYN

10in 2025

2007high 16 (2007) · low 0 (2017)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · IYN

610in 2025

2007high 610 (2025) · low 2 (2008)2025

MAUDE reports naming product code IYN, 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	13	26	16	3
2008	25	18	12	2
2009	18	29	8	9
2010	29	67	10	17
2011	39	46	8	18
2012	43	37	3	20
2013	51	60	8	18
2014	56	39	2	48
2015	54	55	3	116
2016	60	56	2	145
2017	64	83	0	146
2018	59	85	7	85
2019	47	79	0	59
2020	57	72	4	67
2021	46	105	8	213
2022	53	105	10	186
2023	44	115	4	229
2024	50	119	1	266
2025	57	124	10	610
2026	44	107	2 (1)	—

https://510kreport.com/device/K981397 · printed Nov 5, 2026

Cite this page

510(k) Report. “K981397: Harmonic Imaging and Flash Echo Imaging Function for the Diagnostic Ultrasound System Ssa-380A, Powervision 7000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K981397

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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