510(k) · Cleared

Recalled · Class II · 2012

Select/SP

K961464510(k) TraditionalCleared Jul 3, 199677-day reviewClass II21 CFR 892.1750Recalls 3

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

Elscint, Inc. · JAK System, X-Ray, Tomography, Computed

Cleared on Jul 3, 1996 as substantially equivalent to K930090 (Elscint, Inc., 1993) after a 77-day review. Its family tree reaches back 1 generation to 1993. 265 later devices descend from it. It has been recalled 3 times.

Decided: Jul 3, 1996
Review: 77 days
Class: Class II
Product code: JAK
Recalls: 3
Predicates: 1

Its longest line of descent runs back 1 generation to K930090 (1993). 265 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 1 generation backK930090 HelicatElscint, Inc. · 1993
This deviceK961464 Select/SPElscint, Inc. · 1996
Descendant · cites it directly · 264 of its ownK982060 Volumax CT Imaging SystemElscint, Inc. · 1998
Descendant · 2 generations on · 263 of its ownK012009 MX8000 Idt CT SystemMarconi Medical Systems, Inc. · 2001 · Recalled
Descendant · 3 generations on · 214 of its ownK033326 Philips Plus Computed Tomography SystemPhilips Medical Systems, Inc. · 2003 · Recalled
Descendant · 3 generations on · 147 of its ownK042293 Brilliance CT, Private Practice CV Configuration, CT ScannerPhilips Medical Systems (Cleveland), Inc. · 2004 · Recalled
Descendant · 4 generations on · 92 of its ownK130159 Qlab Quantification Software Heart ModelPhilips Health Care · 2013

Showing 5 of 265 descendants. See all descendants

Descendants cleared per year

1998high 35 (2025) · low 0 (1999)2026

Most influential descendants

Showing 5 of 265 · See all

K982060Volumax CT Imaging SystemElscint, Inc. · 1998 · cites it directly264descendants
K012009MX8000 Idt CT SystemMarconi Medical Systems, Inc. · 2001 · 2 generations on263descendants
K033326Philips Plus Computed Tomography SystemPhilips Medical Systems, Inc. · 2003 · 3 generations on214descendants
K042293Brilliance CT, Private Practice CV Configuration, CT ScannerPhilips Medical Systems (Cleveland), Inc. · 2004 · 3 generations on147descendants
K130159Qlab Quantification Software Heart ModelPhilips Health Care · 2013 · 4 generations on92descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K930090	Helicat	Elscint, Inc.	1993	—
0 (this device)	K961464	Select/SP	Elscint, Inc.	1996	—
+1	K982060	Volumax CT Imaging System	Elscint, Inc.	1998	—
+2	K012009	MX8000 Idt CT System	Marconi Medical Systems, Inc.	2001	61
+3	K033326	Philips Plus Computed Tomography System	Philips Medical Systems, Inc.	2003	131
+3	K042293	Brilliance CT, Private Practice CV Configuration, CT Scanner	Philips Medical Systems (Cleveland), Inc.	2004	1
+4	K130159	Qlab Quantification Software Heart Model	Philips Health Care	2013	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1998	1	0
2001	1	0
2003	3	0
2004	7	0
2005	3	0
2006	3	0
2007	3	0
2008	7	0
2009	4	0
2010	2	0
2011	4	0
2012	6	0
2013	6	0
2014	9	0
2015	3	0
2016	5	0
2017	12	0
2018	14	0
2019	9	0
2020	22	0
2021	19	0
2022	22	0
2023	20	0
2024	19	0
2025	35	0
2026	26	0

FIG. 1 — Lineage of K961464, 1993–2026Source: 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
*	K930090	Helicat Summary page 1 …ain Features The SeleCT/SP is a cost effective spiral scanner, with compact siting requirements and real-time image processing functions. . Predicate Devices e HeliCAT, K930090. e QOther related devices: O Exel 905 GT, K884667 % AngioCT. K932508/B 0 ProVision by Algotec Ltd., Raanana, Israel, K954678…	Elscint, Inc.	1993	—
†	K884667	Exel 905 Series CT Scanner	Elscint, Inc.	1988	—

Also cleared against K930090: 1 other device →

What descends from it? (265)

See all 265

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

Number	Device	Applicant	Decided	Descendants
K982060	Volumax CT Imaging System	Elscint, Inc.	1998	264
K023785	Lung Nodule Assessment and Comparison Option	Philips Medical Systems (Cleveland), Inc.	2003	10
K033677	Brain Perfusion Option	Philips Medical Systems (Cleveland), Inc.	2004	3

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Sep 28, 2012	Class II	Z-0479-2013	Software design	Philips is issued a Field Change Order to update Extended Brilliance Workspace (EBW) systems to software version 4.5.5. The update will provide a number of improvements to address nonhazardous reliability issues which will improve the…
Sep 28, 2012	Class II	Z-0906-2013	Software design	Incorrect values may be displayed. Philips is issuing a software update (version 4.5.5) to the Extended Brilliance Workspace (EBW) systems currently running software version(s) 4.0.2, V4.5.2 or V4.5.3, addressing a number of…
Sep 11, 2012	Class II	Z-0675-2013	Software design	Philips was notified that when performing post processing with the Brilliance Workspace Portal platform with software versions 2.6.1.4, the coronary arteries in the rendered image are segmented automatically. However, the center line is…

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has no recall.
Of its descendants, K982060 (Elscint, Inc., 1998) has gone furthest, with 264 descendants of its own.
1 other device also cites its predicate K930090.

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	—

https://510kreport.com/device/K961464 · printed Nov 6, 2026

Cite this page

510(k) Report. “K961464: Select/SP.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K961464

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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