510(k) · Cleared

Recalled · Class II · 2013

Aplio XG Diagnostic Ultrasound System Model Ssa-790A Version 4.0

K091295510(k) TraditionalCleared May 15, 200911-day reviewClass II21 CFR 892.1570Recalls 2

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 · ITX Transducer, Ultrasonic, Diagnostic

Cleared on May 15, 2009 as substantially equivalent to K082119 (Toshiba America Medical Systems, In.C, 2008) after an 11-day review. Its family tree reaches back 11 generations to 1989. 22 later devices descend from it. It has been recalled 2 times.

Decided: May 15, 2009
Review: 11 days
Class: Class II
Product code: ITX
Recalls: 2
Predicates: 1

Its longest line of descent runs back 11 generations to K894632 (1989). 56 ancestors in all. 22 later devices descend from it, 4 citing it directly.

By dateBy generation

Root · 11 generations backK894632 Model SSH-140A Ultrasound Imaging SystemToshiba America Medical Systems, In.C · 1989
7 generations between
3 generations backK072000 Aplio XG Diagnostic Ultrasound System, Model Ssa-790A Version 2.0Toshiba America Medical Systems, In.C · 2007
2 generations backK081065 Aplio XG Diagnostic Ultrasound System, Model Ssa - 790A, Version 2.2Toshiba America Medical Systems, In.C · 2008
1 generation backK082119 Aplio XG Diagnostic Ultrasound System, Model Ssa - 790A Version 3.0Toshiba America Medical Systems, In.C · 2008
This deviceK091295 Aplio XG Diagnostic Ultrasound System Model Ssa-790A Version 4.0Toshiba America Medical Systems, In.C · 2009
Descendant · cites it directly · 11 of its ownK093171 Viamo Ssa-640A Version 1.2Toshiba America Medical Systems, In.C · 2009
Descendant · cites it directly · 9 of its ownK092179 Aplio XG Diagnostic Ultrasound System, Model Ssa - 790A Version…Toshiba America Medical Systems, In.C · 2009 · Recalled
Descendant · 2 generations on · 6 of its ownK103629 Pet-512MC Transesophageal TransducerToshiba America Medical Systems, In.C · 2011
Descendant · 3 generations on · 5 of its ownK161960 bk2300Bk Medical Aps · 2016
Descendant · 2 generations on · 5 of its ownK142197 Ultrasound System Sonimage HS1, Linear Probe L18-4, Convex Probe C5-2Konica Minolta, Inc. · 2014 · Recalled

Show all 11 generations

Root · 11 generations backK894632 Model SSH-140A Ultrasound Imaging SystemToshiba America Medical Systems, In.C · 1989
10 generations backK941593 Diagnostic Ultrasonic TransducerToshiba America Medical Systems, In.C · 1996
9 generations backK970047 Phased Array Transducer - - PSK-20CTToshiba America Medical Systems, In.C · 1997
8 generations backK991858 Ssa-390A/Power Vision 8000Toshiba America Medical Systems, In.C · 1999
7 generations backK013633 Ssa-770A, Aplio Ultrasound SystemToshiba America Medical Systems, In.C · 2001
6 generations backK022400 Ssa-700A, Aplio Diagnostic Ultrasound SystemToshiba America Medical Systems, In.C · 2002 · Recalled
5 generations backK032281 Ssa-770A - Version 4, Aplio Diagnostic Ultrasound SystemToshiba America Medical Systems, In.C · 2003
4 generations backK063130 Aplio XG Diagnostic Ultrasound System, Model Ssa-790A, Version 1.0Toshibamedical Systems Corporation · 2006 · Recalled
3 generations backK072000 Aplio XG Diagnostic Ultrasound System, Model Ssa-790A Version 2.0Toshiba America Medical Systems, In.C · 2007
2 generations backK081065 Aplio XG Diagnostic Ultrasound System, Model Ssa - 790A, Version 2.2Toshiba America Medical Systems, In.C · 2008
1 generation backK082119 Aplio XG Diagnostic Ultrasound System, Model Ssa - 790A Version 3.0Toshiba America Medical Systems, In.C · 2008
This deviceK091295 Aplio XG Diagnostic Ultrasound System Model Ssa-790A Version 4.0Toshiba America Medical Systems, In.C · 2009

Showing 5 of 22 descendants. See all descendants

Descendants cleared per year

2009high 4 (2012) · low 0 (2013)2026

Most influential descendants

Showing 5 of 22 · See all

K093171Viamo Ssa-640A Version 1.2Toshiba America Medical Systems, In.C · 2009 · cites it directly11descendants
K092179Aplio XG Diagnostic Ultrasound System, Model Ssa - 790A Version 4.0R001Toshiba America Medical Systems, In.C · 2009 · cites it directly9descendants
K103629Pet-512MC Transesophageal TransducerToshiba America Medical Systems, In.C · 2011 · 2 generations on6descendants
K161960bk2300Bk Medical Aps · 2016 · 3 generations on5descendants
K142197Ultrasound System Sonimage HS1, Linear Probe L18-4, Convex Probe C5-2Konica Minolta, Inc. · 2014 · 2 generations on5descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−11	K894632	Model SSH-140A Ultrasound Imaging System	Toshiba America Medical Systems, In.C	1989	—
−10	K941593	Diagnostic Ultrasonic Transducer	Toshiba America Medical Systems, In.C	1996	—
−9	K970047	Phased Array Transducer - - PSK-20CT	Toshiba America Medical Systems, In.C	1997	—
−8	K991858	Ssa-390A/Power Vision 8000	Toshiba America Medical Systems, In.C	1999	—
−7	K013633	Ssa-770A, Aplio Ultrasound System	Toshiba America Medical Systems, In.C	2001	—
−6	K022400	Ssa-700A, Aplio Diagnostic Ultrasound System	Toshiba America Medical Systems, In.C	2002	1
−5	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
−3	K072000	Aplio XG Diagnostic Ultrasound System, Model Ssa-790A Version 2.0	Toshiba America Medical Systems, In.C	2007	—
−2	K081065	Aplio XG Diagnostic Ultrasound System, Model Ssa - 790A, Version 2.2	Toshiba America Medical Systems, In.C	2008	—
−1	K082119	Aplio XG Diagnostic Ultrasound System, Model Ssa - 790A Version 3.0	Toshiba America Medical Systems, In.C	2008	—
0 (this device)	K091295	Aplio XG Diagnostic Ultrasound System Model Ssa-790A Version 4.0	Toshiba America Medical Systems, In.C	2009	—
+1	K093171	Viamo Ssa-640A Version 1.2	Toshiba America Medical Systems, In.C	2009	—
+1	K092179	Aplio XG Diagnostic Ultrasound System, Model Ssa - 790A Version 4.0R001	Toshiba America Medical Systems, In.C	2009	1
+2	K103629	Pet-512MC Transesophageal Transducer	Toshiba America Medical Systems, In.C	2011	—
+3	K161960	bk2300	Bk Medical Aps	2016	—
+2	K142197	Ultrasound System Sonimage HS1, Linear Probe L18-4, Convex Probe C5-2	Konica Minolta, Inc.	2014	2

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1992	1	0
1993	1	0
1994	5	0
1995	5	0
1996	2	0
1997	6	0
1998	2	0
1999	6	0
2000	3	0
2001	1	0
2002	2	0
2003	4	0
2004	3	0
2005	2	0
2006	2	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2009	3	0
2010	1	0
2011	2	0
2012	4	0
2014	1	0
2015	2	0
2016	2	0
2018	3	0
2022	2	0
2023	2	0

FIG. 1 — Lineage of K091295, 1989–2023Source: 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.

Planning a device in ITX? 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 ITX device

#1 K260114 Align® Cover and Pad Guidance Toolscore 13.6 · 6 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? (1)

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
*	K082119	Aplio XG Diagnostic Ultrasound System, Model Ssa - 790A Version 3.0 Summary page 4 …4,5.6,7,9 Other (Specify) .. . N = new indication: P = previously cleared by FDA: E = added under this appendix Previous 5 10(k) of the transducer: K082119 Note I Small organ includes thyroid. breast and testicle. Note 2 Combined mode includes B/M: B/PWD: BDF/PWD: BDF/MDF; BDF/MDF/PW…	Toshiba America Medical Systems, In.C	2008	—

Also cleared against K082119: 1 other device →

What descends from it? (22)

See all 22

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

Number	Device	Applicant	Decided	Descendants
K093171	Viamo Ssa-640A Version 1.2	Toshiba America Medical Systems, In.C	2009	11
K092179	Aplio XG Diagnostic Ultrasound System, Model Ssa - 790A Version 4.0R001	Toshiba America Medical Systems, In.C	2009	9
K100067	Model Viamo Ssa-640A, Version 2.0 Ultrasound System	Toshiba America Medical Systems, In.C	2010	1
K092948	Aplio MX Ssa-780A, Version 1.0	Toshiba America Medical Systems, In.C	2009	0

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Aug 5, 2013	Class II	Z-0122-2014	Device Design	The firm initiated this recall of certain Toshiba Diagnostic Ultrasound Systems because it has been found that under certain conditions, the temperature of the transducer head may increase in 2D+PW mode or 2D+CDI (POWER, ADF) +PW mode.…
Jun 2, 2010	Not classified	Z-2981-2011	Device Design	Toshiba America Medical Systems Inc (TAMS) is initiating a field correction on the the Aplio XG model SSA-790A because it did not meet the requirement of clause 15b, IEC60601-1 which requires that the residual voltage shall not exceed 60V…

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 20 years and passes through 2 companies; a new generation was cleared every 10 months on median.
7 of the 56 ancestors have a recall of any class.
Of its descendants, K093171 (Toshiba America Medical Systems, In.C, 2009) has gone furthest, with 11 descendants of its own.
1 other device also cites its predicate K082119.

How does its category compare?

All ITX devices

ITX Transducer, Ultrasonic, Diagnostic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.

FDA decisions per year · ITX

4in 2025

2007high 17 (2009) · low 1 (2015)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · ITX

126in 2025

2007high 213 (2023) · low 16 (2011)2026

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

Recalls per year · ITX

2in 2025

2007high 15 (2018) · low 0 (2007)2026

Class I (10 since 2007) Class II/III not classified

Adverse event reports per year · ITX

571in 2025

2007high 988 (2024) · low 16 (2007)2025

MAUDE reports naming product code ITX, 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	10	26	0	16
2008	12	73	4	39
2009	17	28	4	23
2010	10	42	4	30
2011	10	16	1	34
2012	7	25	1	29
2013	3	105	0	38
2014	4	41	1	43
2015	1	—	5	183
2016	4	151	0	269
2017	6	110	1	412
2018	2	—	15	130
2019	1	—	0	119
2020	3	120	3	116
2021	3	139	10 (10)	146
2022	2	—	6	87
2023	6	213	1	138
2024	3	81	1	988
2025	4	126	2	571
2026	6	158	0	—

What is it indicated for?

The Aplio v4.0 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 as stated in the FDA summary.

https://510kreport.com/device/K091295 · printed Nov 4, 2026

Cite this page

510(k) Report. “K091295: Aplio XG Diagnostic Ultrasound System Model Ssa-790A Version 4.0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K091295

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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