510(k) · Cleared

Cleared

C-Pet Plus Imaging System

K042839510(k) TraditionalCleared Oct 29, 200415-day reviewClass II21 CFR 892.1200

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. · KPS System, Tomography, Computed, Emission

Cleared on Oct 29, 2004 as substantially equivalent to K973396 (Ugm Medical Systems, Inc., 1998) and 1 other predicate after a 15-day review. Its family tree reaches back 2 generations to 1993.

Decided: Oct 29, 2004
Review: 15 days
Class: Class II
Product code: KPS
Recalls: None
Predicates: 2

Its longest line of descent runs back 2 generations to K930428 (1993). 4 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK930428 Penn-Pet ScannerUgm Medical Systems, Inc. · 1993
1 generation backK973396 Quest Pet Imaging SystemUgm Medical Systems, Inc. · 1998
This deviceK042839 C-Pet Plus Imaging SystemPhilips Medical Systems (Cleveland), Inc. · 2004

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K930428	Penn-Pet Scanner	Ugm Medical Systems, Inc.	1993	—
−1	K973396	Quest Pet Imaging System	Ugm Medical Systems, Inc.	1998	—
0 (this device)	K042839	C-Pet Plus Imaging System	Philips Medical Systems (Cleveland), Inc.	2004	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2000	1	0
2003	1	0

FIG. 1 — Lineage of K042839, 1993–2004Source: 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 KPS? 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 KPS device

#1 K253564 uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI…score 18.6 · 17 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
*	K973396	Quest Pet Imaging System Summary page 1 ….1200, Class II Product Code: 90OKPS C. Date prepared: August 20, 2004 D. Predicate Device: Sentry Imaging System (K973396, 01/21/1998) Allegro Imaging System (K033782, 12/19/2003) E. Performance Standards: NEM…	Ugm Medical Systems, Inc.	1998	—
*	K033782	Allegro Imaging System Summary page 1 …August 20, 2004 D. Predicate Device: Sentry Imaging System (K973396, 01/21/1998) Allegro Imaging System (K033782, 12/19/2003) E. Performance Standards: NEMA NU-2 F. Intended Use: The device is a Positron Emission Tomography (PET) I…	Philips Medical Systems (Cleveland), Inc.	2003	—

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?

The line of descent spans 11 years and passes through 2 companies; a new generation was cleared every 6.8 years on median.
None of the 4 ancestors has a recall.

How does its category compare?

All KPS devices

KPS System, Tomography, Computed, Emission: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KPS

12in 2025

2007high 17 (2008) · low 3 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KPS

65in 2025

2007high 112 (2015) · low 25 (2008)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · KPS

16in 2025

2007high 34 (2011) · low 4 (2010)2026

Class I (17 since 2007) Class II/III not classified

Adverse event reports per year · KPS

36in 2025

2007high 240 (2013) · low 10 (2016)2025

MAUDE reports naming product code KPS, 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	8	38	22	38
2008	17	25	16	11
2009	9	42	14	15
2010	3	91	4	44
2011	7	28	34	56
2012	6	94	13	34
2013	11	84	13	240
2014	11	92	18	33
2015	3	112	5	24
2016	11	65	16	10
2017	11	104	11	31
2018	13	59	12 (3)	26
2019	3	60	5 (5)	105
2020	12	72	8	22
2021	15	66	4	10
2022	5	60	8 (6)	15
2023	12	63	6 (3)	22
2024	11	59	15	23
2025	12	65	16	36
2026	6	67	6	—

What is it indicated for?

The device is a Positron Emission Tomography (PET) Imaging System. It is intended

to produce images depicting the anatomical distributions of single photon and

positron emitting radioisotopes with the human body for interpretation by medical

personnel.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K042839 · printed Nov 5, 2026

Cite this page

510(k) Report. “K042839: C-Pet Plus Imaging System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K042839

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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