510(k) · Cleared

Recalled · 2008

Hispeed Dual

K021491510(k) TraditionalCleared May 22, 200213-day reviewClass II21 CFR 892.1750Recalls 2

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Ge Medical Systems, Inc. · JAK System, X-Ray, Tomography, Computed

Cleared on May 22, 2002 as substantially equivalent to K993645 (Ge Medical Systems, Inc., 1999) after a 13-day review. Its family tree reaches back 2 generations to 1998. It has been recalled 2 times.

Decided: May 22, 2002
Review: 13 days
Class: Class II
Product code: JAK
Recalls: 2
Predicates: 1

Its longest line of descent runs back 2 generations to K980169 (1998). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK980169 Hispeed LX//I, Hispeed FX/I, and Hispeed DX/I Family of SystemsGeneral Electric Co. · 1998 · Recalled
1 generation backK993645 CT/E Computed Tomography Scannner SystemGe Medical Systems, Inc. · 1999 · Recalled
This deviceK021491 Hispeed DualGe Medical Systems, Inc. · 2002

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K980169	Hispeed LX//I, Hispeed FX/I, and Hispeed DX/I Family of Systems	General Electric Co.	1998	2
−1	K993645	CT/E Computed Tomography Scannner System	Ge Medical Systems, Inc.	1999	2
0 (this device)	K021491	Hispeed Dual	Ge Medical Systems, Inc.	2002	—

FIG. 1 — Lineage of K021491, 1998–2002Source: 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? (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
*	K993645	CT/E Computed Tomography Scannner System Summary page 2 …nsole ,computer and associated accessories. Materials: All construction and materials are complaint with 21 CFR Subchapter J and IEC 60601-1 and are equivalent to CT/e (K993645) Design: The system is designed to be a head and whole body CT scanner utilizing a solid state detector and an intutive Operato…	Ge Medical Systems, Inc.	1999	2

What descends from it?

No later submission names this one as a predicate yet.

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Dec 1, 2008	Not classified	Z-2224-2009	Radiation Control for Health and Safety Act	During internal testing, GE Healthcare has recently determined that the collimator used on our CT/e and HiSpeed X/i families of Computed Tomography systems does not comply with the specific requirements in United States Title 21 of the…
Oct 21, 2004	Not classified	Z-0269-05	Other	The patient tables of the affected CT systems are supported by a hydraulic cylinder and a cylinder shaft (i.e. the upper shaft) which connects the tabletop to the table frame. GE received a report of a HiSpeed LX/I system table falling…

No ancestor or descendant has a 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 2.4 years on median.
2 of the 2 ancestors have a recall of any class.

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?

The Hispeed CT/e Dual Computed Tomography System is indicated for head and whole body X-ray Computed Tomography applications.

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/K021491 · printed Nov 4, 2026

Cite this page

510(k) Report. “K021491: Hispeed Dual.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K021491

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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