510(k) · Cleared

Cleared

FACTS

K982010510(k) TraditionalCleared Nov 19, 1998164-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 (Cleveland), Inc. · JAK System, X-Ray, Tomography, Computed

Cleared on Nov 19, 1998 as substantially equivalent to K955268 (Philips Medical Systems (Cleveland), Inc., 1996) and 2 other predicates after a 164-day review. Its family tree reaches back 1 generation to 1980.

Decided: Nov 19, 1998
Review: 164 days
Class: Class II
Product code: JAK
Recalls: None
Predicates: 3

Its longest line of descent runs back 1 generation to K800639 (1980). 3 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK800639 OrbitorPhilips Medical Systems (Cleveland), Inc. · 1980
This deviceK982010 FACTSPhilips Medical Systems (Cleveland), Inc. · 1998

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K800639	Orbitor	Philips Medical Systems (Cleveland), Inc.	1980	—
0 (this device)	K982010	FACTS	Philips Medical Systems (Cleveland), Inc.	1998	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1996	1	0
1998	1	0

FIG. 1 — Lineage of K982010, 1980–1998Source: 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? (3)

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
*	K955268	PQ-2000+ Computed Tomography X-Ray System Summary page 2 …mbination of legally marketed devices with a SSXI. The intended use of the FACTS is the same as legally marketed device PQ2000+ CT System granted marketing permission in K955268 combined with a C-Arm including the DynaRad Diagnostic Source Assembly cleared in K981267 and a SSXI subject of this 510(k) manuf…	Philips Medical Systems (Cleveland), Inc.	1996	1
*	K981267	Facts Monoblock Summary page 2 …me as legally marketed device PQ2000+ CT System granted marketing permission in K955268 combined with a C-Arm including the DynaRad Diagnostic Source Assembly cleared in K981267 and a SSXI subject of this 510(k) manufactured by Varian for Picker that is equivalent to the image intensifier of the Orbitor cl…	Dynarad Corp.	1998	—
*	K800639	Orbitor Summary page 2 …rce Assembly cleared in K981267 and a SSXI subject of this 510(k) manufactured by Varian for Picker that is equivalent to the image intensifier of the Orbitor cleared in K800639. No new questions of safety or effectiveness are raised with the combination and introduction of this device. (4) A description…	Philips Medical Systems (Cleveland), Inc.	1980	—

What descends from it?

No later submission names this one as a predicate yet.

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?

1 of the 3 ancestors has 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 FACTS is Intended to produce routine cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axlal plane takep at different angles of the entire human body. In addition, this device's fluoroscopic mode is intended to be used in CT interventional procedures and allows some minimally invasive surgical procedures to be implemented with the CT §ystem. Procedures possible with this equipment include tumor biopsies, abscess drainage’s, bone Intervention, visceral, neck trauma evaluation and catheter placement for organ assessment.

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/K982010 · printed Nov 6, 2026

Cite this page

510(k) Report. “K982010: FACTS.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K982010

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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