510(k) · Cleared

Cleared

Philips Tomoscan SR 8000

K954255510(k) TraditionalCleared Oct 7, 199526-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

Philips Medical Systems North America, Inc. · JAK System, X-Ray, Tomography, Computed

Cleared on Oct 7, 1995 after a 26-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 19 later devices descend from it.

Decided: Oct 7, 1995
Review: 26 days
Class: Class II
Product code: JAK
Recalls: None
Predicates: 0

19 later devices descend from it, 2 citing it directly.

This deviceK954255 Philips Tomoscan SR 8000Philips Medical Systems North America, Inc. · 1995
Descendant · cites it directly · 17 of its ownK991278 Philips Tomoscan AV-NTPhilips Medical Systems North America, Inc. · 1999
Descendant · 2 generations on · 16 of its ownK014240 ProntoHitachi Medical Systems America, Inc. · 2002
Descendant · 3 generations on · 15 of its ownK040902 Hitachi PrestoHitachi Medical Systems America, Inc. · 2004 · Recalled
Descendant · 4 generations on · 12 of its ownK071806 Eclos Computed Tomography X-Ray SystemHitachi Medical Systems America, Inc. · 2007 · Recalled
Descendant · 5 generations on · 9 of its ownK102677 Bodytom NL 4000Neurologica Corporation · 2011

Showing 5 of 19 descendants. See all descendants

Descendants cleared per year

1997high 2 (2004) · low 0 (1998)2026

Most influential descendants

Showing 5 of 19 · See all

K991278Philips Tomoscan AV-NTPhilips Medical Systems North America, Inc. · 1999 · cites it directly17descendants
K014240ProntoHitachi Medical Systems America, Inc. · 2002 · 2 generations on16descendants
K040902Hitachi PrestoHitachi Medical Systems America, Inc. · 2004 · 3 generations on15descendants
K071806Eclos Computed Tomography X-Ray SystemHitachi Medical Systems America, Inc. · 2007 · 4 generations on12descendants
K102677Bodytom NL 4000Neurologica Corporation · 2011 · 5 generations on9descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K954255	Philips Tomoscan SR 8000	Philips Medical Systems North America, Inc.	1995	—
+1	K991278	Philips Tomoscan AV-NT	Philips Medical Systems North America, Inc.	1999	—
+2	K014240	Pronto	Hitachi Medical Systems America, Inc.	2002	—
+3	K040902	Hitachi Presto	Hitachi Medical Systems America, Inc.	2004	4
+4	K071806	Eclos Computed Tomography X-Ray System	Hitachi Medical Systems America, Inc.	2007	1
+5	K102677	Bodytom NL 4000	Neurologica Corporation	2011	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1997	1	0
1999	1	0
2002	1	0
2004	2	0
2006	1	0
2007	1	0
2009	1	0
2011	1	0
2012	1	0
2013	1	0
2014	1	0
2016	1	0
2017	1	0
2018	1	0
2022	1	0
2025	1	0
2026	2	0

FIG. 1 — Lineage of K954255, 1995–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (19)

See all 19

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

Number	Device	Applicant	Decided	Descendants
K991278	Philips Tomoscan AV-NT	Philips Medical Systems North America, Inc.	1999	17
K964318	Philips Tomoscan AV Expander Upgrade	Philips Medical Systems North America, Inc.	1997	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?

Of its descendants, K991278 (Philips Medical Systems North America, Inc., 1999) has gone furthest, with 17 descendants of its own.

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/K954255 · printed Nov 4, 2026

Cite this page

510(k) Report. “K954255: Philips Tomoscan SR 8000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K954255

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Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026