510(k) · Cleared

Recalled · Class II · 2015

Model TSX-101A/H/I Aquilion 32/64 SP CT System

K080211510(k) TraditionalCleared Mar 14, 200845-day reviewClass II21 CFR 892.1750Recalls 8

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 · JAK System, X-Ray, Tomography, Computed

Cleared on Mar 14, 2008 as substantially equivalent to K051833 (Toshiba America Medical Systems, In.C, 2005) after a 45-day review. Its family tree reaches back 3 generations to 2003. 17 later devices descend from it. It has been recalled 8 times.

Decided: Mar 14, 2008
Review: 45 days
Class: Class II
Product code: JAK
Recalls: 8
Predicates: 1

Its longest line of descent runs back 3 generations to K031469 (2003). 17 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 3 generations backK031469 Aquilion Super 4 Multislice CT Scanner, Model TSX-101A/7Toshiba America Medical Systems, In.C · 2003 · Recalled
2 generations backK033418 TSX-101A/a and TSX-101A/C Aquilion Multislice CT ScannersToshiba America Medical Systems, In.C · 2003 · Recalled
1 generation backK051833 TSX-101A/H Aquilion 64 SP CT Scanner; TSX-101A/I Aquilion 32 SP CT…Toshiba America Medical Systems, In.C · 2005
This deviceK080211 Model TSX-101A/H/I Aquilion 32/64 SP CT SystemToshiba America Medical Systems, In.C · 2008
Descendant · cites it directly · 15 of its ownK101888 Scenaria Whole-Body X-Ray CT SystemHitachi Medical Systems America, Inc. · 2011 · Recalled
Descendant · 2 generations on · 14 of its ownK123509 Scenaria Phase 2 Whole-Body X-Ray CT SystemHitachi Medical Systems America, Inc. · 2013
Descendant · 3 generations on · 11 of its ownK161748 SUPRIA w/guideShot OptionHitachi Medical Systems America, Inc. · 2016
Descendant · 4 generations on · 10 of its ownK163528 HITACHI Supria Whole-body X-ray CT System Phase 3Hitachi Medical Systems America, Inc. · 2017
Descendant · 5 generations on · 9 of its ownK171738 Supria True64Hitachi Healthcare Americas Corporation · 2017

Showing 5 of 17 descendants. See all descendants

Descendants cleared per year

2011high 2 (2015) · low 0 (2014)2026

Most influential descendants

Showing 5 of 17 · See all

K101888Scenaria Whole-Body X-Ray CT SystemHitachi Medical Systems America, Inc. · 2011 · cites it directly15descendants
K123509Scenaria Phase 2 Whole-Body X-Ray CT SystemHitachi Medical Systems America, Inc. · 2013 · 2 generations on14descendants
K161748SUPRIA w/guideShot OptionHitachi Medical Systems America, Inc. · 2016 · 3 generations on11descendants
K163528HITACHI Supria Whole-body X-ray CT System Phase 3Hitachi Medical Systems America, Inc. · 2017 · 4 generations on10descendants
K171738Supria True64Hitachi Healthcare Americas Corporation · 2017 · 5 generations on9descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K031469	Aquilion Super 4 Multislice CT Scanner, Model TSX-101A/7	Toshiba America Medical Systems, In.C	2003	1
−2	K033418	TSX-101A/a and TSX-101A/C Aquilion Multislice CT Scanners	Toshiba America Medical Systems, In.C	2003	2
−1	K051833	TSX-101A/H Aquilion 64 SP CT Scanner; TSX-101A/I Aquilion 32 SP CT Scanner	Toshiba America Medical Systems, In.C	2005	—
0 (this device)	K080211	Model TSX-101A/H/I Aquilion 32/64 SP CT System	Toshiba America Medical Systems, In.C	2008	—
+1	K101888	Scenaria Whole-Body X-Ray CT System	Hitachi Medical Systems America, Inc.	2011	3
+2	K123509	Scenaria Phase 2 Whole-Body X-Ray CT System	Hitachi Medical Systems America, Inc.	2013	—
+3	K161748	SUPRIA w/guideShot Option	Hitachi Medical Systems America, Inc.	2016	—
+4	K163528	HITACHI Supria Whole-body X-ray CT System Phase 3	Hitachi Medical Systems America, Inc.	2017	—
+5	K171738	Supria True64	Hitachi Healthcare Americas Corporation	2017	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2011	1	0
2012	1	0
2013	1	0
2015	2	0
2016	1	0
2017	2	0
2019	2	0
2020	1	0
2022	1	0
2023	1	0
2024	1	0
2025	1	0
2026	2	0

FIG. 1 — Lineage of K080211, 2003–2026Source: 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.

Planning a device in JAK? 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 JAK device

#1 K230223 iCAC Devicescore 23.5 · 12 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
*	K051833	TSX-101A/H Aquilion 64 SP CT Scanner; TSX-101A/I Aquilion 32 SP CT Scanner Summary page 2 …ndards. Substantial Equivalence: This device is similar in materials and processes to that of the predicate device, Toshiba TSX-101AfH, /I Aquilion 32/64 SP CT scanner [k051833]. 510(k) Summary Statement. 2 of 2 === Page 3…	Toshiba America Medical Systems, In.C	2005	—

Also cleared against K051833: 2 other devices →

What descends from it? (17)

See all 17

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

Number	Device	Applicant	Decided	Descendants
K101888	Scenaria Whole-Body X-Ray CT System	Hitachi Medical Systems America, Inc.	2011	15
K112989	Aquilion CXL	Toshiba America Medical Systems, In.C	2012	0

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
May 8, 2015	Class II	Z-0013-2016	Radiation Control for Health and Safety Act	If two specific operations are performed in multi-phase helical scanning, the acquired raw data may not be saved.
Oct 1, 2013	Class II	Z-1113-2014	Software design	Toshiba intitiated this recall because their investigation revealed that due to a problem of the X-ray output control software, the X-ray output conditions may not be set correctly. As a result, X-ray exposure under the scan conditions…
Dec 8, 2010	Not classified	Z-3221-2011	Software design	There is the potential that the current may not be controlled correctly in examinations using the ECG modulation function, which adjusts the x-ray output in synchronization with the ECG waveform.
Apr 9, 2010	Not classified	Z-2204-2011	Software design	The recall was initiated by Toshiba America Medical Systems (TAMS) because the software associated with TSX-101A: Aquilion 64 can prevent scanning from being performed at the specified helical pitch (couch movement speed).
Jan 8, 2009	Not classified	Z-1168-2010	Component design/selection	Toshiba America Medical Systems Inc (TAMS) has initiated a field correction on the Aquilion 32 CT Scanners due to the potential for the bolus tracking software (SureStart) to cause delay of the helical scan, up to 10 seconds, when large…
Jan 8, 2009	Not classified	Z-1166-2010	Component design/selection	Toshiba America Medical Systems Inc (TAMS) has initiated a field correction on the Aquilion 32 CT Scanners due to the potential for the bolus tracking software (SureStart) to cause delay of the helical scan, up to 10 seconds, when large…
Jan 8, 2009	Not classified	Z-1167-2010	Component design/selection	Toshiba America Medical Systems Inc (TAMS) has initiated a field correction on the Aquilion 32 CT Scanners due to the potential for the bolus tracking software (SureStart) to cause delay of the helical scan, up to 10 seconds, when large…
Jan 8, 2009	Not classified	Z-1169-2010	Component design/selection	Toshiba America Medical Systems Inc (TAMS) has initiated a field correction on the Aquilion 32 CT Scanners due to the potential for the bolus tracking software (SureStart) to cause delay of the helical scan, up to 10 seconds, when large…

The 5 latest of 8 recalls; the web page lists all.

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 5 years and passes through 1 company; a new generation was cleared every 1.7 years on median.
2 of the 3 ancestors have a recall of any class.
Of its descendants, K101888 (Hitachi Medical Systems America, Inc., 2011) has gone furthest, with 15 descendants of its own.
2 other devices also cite its predicate K051833.

How does its category compare?

All JAK devices

JAK System, X-Ray, Tomography, Computed: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.

FDA decisions per year · JAK

27in 2025

2007high 30 (2014) · low 7 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JAK

141in 2025

2007high 200 (2014) · low 27 (2007)2026

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

Recalls per year · JAK

17in 2025

2007high 51 (2010) · low 5 (2019)2026

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

Adverse event reports per year · JAK

219in 2025

2007high 543 (2018) · low 76 (2007)2025

MAUDE reports naming product code JAK, 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	14	27	11	76
2008	26	42	16	120
2009	15	31	29	105
2010	7	92	51	119
2011	16	155	34	205
2012	28	121	23	192
2013	17	132	11	414
2014	30	200	10	308
2015	30	140	28	454
2016	25	129	44	365
2017	29	96	33	338
2018	24	114	10	543
2019	28	94	5	233
2020	30	112	8	177
2021	20	145	15	261
2022	30	131	9	199
2023	27	139	9	310
2024	26	141	20	212
2025	27	141	17	219
2026	21	167	23	—

What is it indicated for?

Acquisition and display of axial x-ray images of the whole body to include the head.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K080211 · printed Nov 6, 2026

Cite this page

510(k) Report. “K080211: Model TSX-101A/H/I Aquilion 32/64 SP CT System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K080211

Report an extraction error

Are you the manufacturer?

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