510(k) · Cleared

Cleared

Ecg-Gating System for Aquilion CT Scanner, TSX-101A

K991766510(k) TraditionalCleared Aug 10, 199978-day reviewClass II21 CFR 892.1750

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 Aug 10, 1999 as substantially equivalent to K982265 (Toshiba America Medical Systems, In.C, 1998) and 1 other predicate after a 78-day review. Its family tree reaches back 3 generations to 1990. 1 later device descends from it.

Decided: Aug 10, 1999
Review: 78 days
Class: Class II
Product code: JAK
Recalls: None
Predicates: 2

Its longest line of descent runs back 3 generations to K903701 (1990). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 3 generations backK903701 XpressToshiba America Medical Systems, In.C · 1990
2 generations backK982265 Aquilion CT Scanner, Model TSX-101AToshiba America Medical Systems, In.C · 1998 · Recalled
1 generation backK990134 Multislice Upgrade Kit for Aquilion CT Scanner, TSX-101A…Toshiba America Medical Systems, In.C · 1999
This deviceK991766 Ecg-Gating System for Aquilion CT Scanner, TSX-101AToshiba America Medical Systems, In.C · 1999
Descendant · cites it directly · 0 of its ownK160350 ECG CT Gating DeviceNeocoil, LLC · 2016

Most influential descendants

Showing 1 of 1 · See all

K160350ECG CT Gating DeviceNeocoil, LLC · 2016 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K903701	Xpress	Toshiba America Medical Systems, In.C	1990	—
−2	K982265	Aquilion CT Scanner, Model TSX-101A	Toshiba America Medical Systems, In.C	1998	3
−1	K990134	Multislice Upgrade Kit for Aquilion CT Scanner, TSX-101A (Aquilion,Multi)	Toshiba America Medical Systems, In.C	1999	—
0 (this device)	K991766	Ecg-Gating System for Aquilion CT Scanner, TSX-101A	Toshiba America Medical Systems, In.C	1999	—
+1	K160350	ECG CT Gating Device	Neocoil, LLC	2016	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2016	1	0

FIG. 1 — Lineage of K991766, 1990–2016Source: 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

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What was it cleared against? (2)

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
*	K982265	Aquilion CT Scanner, Model TSX-101A Summary page 1 …X-Ray [Fed. Reg. No. 892.1750, Pro. Code: 90JAK] IT (per 21 CFR 892.1750) 21 CFR Subchapter J, Federal Diagnostic X-ray Equipment Standard Toshiba TSX-101A, Aquilion [K982265, K990134] Siemens SOMATOM Plus 4 with Volume Zoom [K982349] GE LightSpeed QXi [K980176] Modification of cleared device The ECG…	Toshiba America Medical Systems, In.C	1998	3
*	K990134	Multislice Upgrade Kit for Aquilion CT Scanner, TSX-101A (Aquilion,Multi) Summary page 1 …d. Reg. No. 892.1750, Pro. Code: 90JAK] IT (per 21 CFR 892.1750) 21 CFR Subchapter J, Federal Diagnostic X-ray Equipment Standard Toshiba TSX-101A, Aquilion [K982265, K990134] Siemens SOMATOM Plus 4 with Volume Zoom [K982349] GE LightSpeed QXi [K980176] Modification of cleared device The ECG-Gating S…	Toshiba America Medical Systems, In.C	1999	—

Also cleared against K982265: 2 other devices →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K160350	ECG CT Gating Device	Neocoil, LLC	2016	0

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

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 9 years and passes through 1 company; a new generation was cleared every 7 months on median.
1 of the 3 ancestors has a recall of any class.
Of its descendants, K160350 (Neocoil, LLC, 2016) has gone furthest, with 0 descendants of its own.
2 other devices also cite its predicate K982265.

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?

This device is indicated to produce cross-sectional images of a human body by reconstruction of x-ray transmission data from the same axial plane taken at different angles. This specific model employs the use of ECG signals to specify the timing of the x-ray transmission commencement.

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/K991766 · printed Nov 5, 2026

Cite this page

510(k) Report. “K991766: Ecg-Gating System for Aquilion CT Scanner, TSX-101A.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K991766

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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