510(k) · Cleared

Recalled · 2011

TSX-201A Aquilion LB CT Scanner

K050458510(k) TraditionalCleared Mar 10, 200515-day reviewClass II21 CFR 892.1750Recalls 1

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 10, 2005 as substantially equivalent to K022050 (Toshiba America Medical Systems, In.C, 2002) after a 15-day review. Its family tree reaches back 4 generations to 1990. 12 later devices descend from it. It has been recalled once.

Decided: Mar 10, 2005
Review: 15 days
Class: Class II
Product code: JAK
Recalls: 1
Predicates: 1

Its longest line of descent runs back 4 generations to K903701 (1990). 12 later devices descend from it, 4 citing it directly.

By dateBy generation

Root · 4 generations backK903701 XpressToshiba America Medical Systems, In.C · 1990
3 generations backK982265 Aquilion CT Scanner, Model TSX-101AToshiba America Medical Systems, In.C · 1998 · Recalled
2 generations backK020385 CGS-30A Multislice Upgrade Kit for Aquilion CT Scanner, Model TSX-101AToshiba America Medical Systems, In.C · 2002
1 generation backK022050 CGS-31A Multislice Upgrade Kit for Aquilion CT Scanner. TSX-101A…Toshiba America Medical Systems, In.C · 2002
This deviceK050458 TSX-201A Aquilion LB CT ScannerToshiba America Medical Systems, In.C · 2005
Descendant · cites it directly · 4 of its ownK123500 Aquilion LB Triton V4.91Toshibamedical Systems Corporation · 2013
Descendant · cites it directly · 4 of its ownK111633 Aquilion LB Movement Base KitToshiba America Medical Systems, In.C · 2011
Descendant · 2 generations on · 3 of its ownK134025 Aquilion One Vision Self-Propelled Scan Base Kit for Ivr-CTToshibamedical Systems Corporation · 2014
Descendant · 3 generations on · 2 of its ownK143223 CGBA-032A, Aquilion PRIME Self-Propelled Scan Base Kit for IVR-CTToshibamedical Systems Corporation · 2015
Descendant · 2 generations on · 2 of its ownK140651 Celesteion, Pca-9000A/2Toshibamedical Systems Corporation · 2014 · Recalled

Showing 5 of 12 descendants. See all descendants

Descendants cleared per year

2006high 2 (2014) · low 0 (2007)2026

Most influential descendants

Showing 5 of 12 · See all

K123500Aquilion LB Triton V4.91Toshibamedical Systems Corporation · 2013 · cites it directly4descendants
K111633Aquilion LB Movement Base KitToshiba America Medical Systems, In.C · 2011 · cites it directly4descendants
K134025Aquilion One Vision Self-Propelled Scan Base Kit for Ivr-CTToshibamedical Systems Corporation · 2014 · 2 generations on3descendants
K143223CGBA-032A, Aquilion PRIME Self-Propelled Scan Base Kit for IVR-CTToshibamedical Systems Corporation · 2015 · 3 generations on2descendants
K140651Celesteion, Pca-9000A/2Toshibamedical Systems Corporation · 2014 · 2 generations on2descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−4	K903701	Xpress	Toshiba America Medical Systems, In.C	1990	—
−3	K982265	Aquilion CT Scanner, Model TSX-101A	Toshiba America Medical Systems, In.C	1998	3
−2	K020385	CGS-30A Multislice Upgrade Kit for Aquilion CT Scanner, Model TSX-101A	Toshiba America Medical Systems, In.C	2002	—
−1	K022050	CGS-31A Multislice Upgrade Kit for Aquilion CT Scanner. TSX-101A (Aquilion…	Toshiba America Medical Systems, In.C	2002	—
0 (this device)	K050458	TSX-201A Aquilion LB CT Scanner	Toshiba America Medical Systems, In.C	2005	—
+1	K123500	Aquilion LB Triton V4.91	Toshibamedical Systems Corporation	2013	—
+1	K111633	Aquilion LB Movement Base Kit	Toshiba America Medical Systems, In.C	2011	—
+2	K134025	Aquilion One Vision Self-Propelled Scan Base Kit for Ivr-CT	Toshibamedical Systems Corporation	2014	—
+3	K143223	CGBA-032A, Aquilion PRIME Self-Propelled Scan Base Kit for IVR-CT	Toshibamedical Systems Corporation	2015	—
+2	K140651	Celesteion, Pca-9000A/2	Toshibamedical Systems Corporation	2014	2

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2006	1	0
2008	1	0
2011	1	0
2013	1	0
2014	2	0
2015	2	0
2017	1	0
2018	2	0
2025	1	0

FIG. 1 — Lineage of K050458, 1990–2025Source: 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
*	K022050	CGS-31A Multislice Upgrade Kit for Aquilion CT Scanner. TSX-101A (Aquilion Advance Multi) Summary page 1 …21 CFR Subchapter J, Federal Diagnostic X-ray Equipment Standard Predicate lDevice(s): TSX-1OIA, Aquilion MS-16 [k022050] Reason For Submission Modification of cleared device Description of this Device: The Aquilion LB is a multi-sl…	Toshiba America Medical Systems, In.C	2002	—

Also cleared against K022050: 1 other device →

What descends from it? (12)

See all 12

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

Number	Device	Applicant	Decided	Descendants
K123500	Aquilion LB Triton V4.91	Toshibamedical Systems Corporation	2013	4
K111633	Aquilion LB Movement Base Kit	Toshiba America Medical Systems, In.C	2011	4
K082244	Pca-8000A, Mark 11, Pet / CT System	Toshiba America Medical Systems, In.C	2008	0
K061187	TSX-201A, Aquilion LB CT Scanner with Respiratory Gating	Toshiba America Medical Systems, In.C	2006	0

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Jun 22, 2011	Not classified	Z-3197-2011	Software design	Toshiba America Medical Systems is initiating a field correction on their TSX-301B: AQUILION Premium; System, X-Ray, Tomography, Computed, TSX-301A: AQUILION One; System, X-Ray, Tomography, Computed, TSX-20IA: AQUlLlON LB; System, X-Ray…

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 15 years and passes through 1 company; a new generation was cleared every 3.5 years on median.
1 of the 4 ancestors has a recall of any class.
Of its descendants, K123500 (Toshibamedical Systems Corporation, 2013) has gone furthest, with 4 descendants of its own.
1 other device also cites its predicate K022050.

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.

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?

X-ray imaging of whole body - Computerized Tomography

Including:

Axial

Volumetric (Helical)

CT Fluoroscopy

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K050458 · printed Nov 6, 2026

Cite this page

510(k) Report. “K050458: TSX-201A Aquilion LB CT Scanner.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050458

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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