510(k) · Cleared

Cleared

Quest Pet Imaging System

K973396510(k) TraditionalCleared Jan 21, 1998149-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

Ugm Medical Systems, Inc. · KPS System, Tomography, Computed, Emission

Cleared on Jan 21, 1998 as substantially equivalent to K930428 (Ugm Medical Systems, Inc., 1993) after a 149-day review. Its family tree reaches back 1 generation to 1993. 1 later device descends from it.

Decided: Jan 21, 1998
Review: 149 days
Class: Class II
Product code: KPS
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K930428 (1993). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK930428 Penn-Pet ScannerUgm Medical Systems, Inc. · 1993
This deviceK973396 Quest Pet Imaging SystemUgm Medical Systems, Inc. · 1998
Descendant · cites it directly · 0 of its ownK042839 C-Pet Plus Imaging SystemPhilips Medical Systems (Cleveland), Inc. · 2004

Most influential descendants

Showing 1 of 1 · See all

K042839C-Pet Plus Imaging SystemPhilips Medical Systems (Cleveland), Inc. · 2004 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

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

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2004	1	0

FIG. 1 — Lineage of K973396, 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? (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
*	K930428	Penn-Pet Scanner Summary page 1 …Positron emission tomograph Classification name: Emission Computed Tomography System 3) Equivalence: PENN-PET Scanner Manufacturer: UGM Medical Systems 510(k) Number: K930428 4) Description of Device: The Quest Positron Emission Tomography (PET) system is a whole body scanner designed to provide true…	Ugm Medical Systems, Inc.	1993	—

Also cleared against K930428: 2 other devices →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K042839	C-Pet Plus Imaging System	Philips Medical Systems (Cleveland), Inc.	2004	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?

Its one ancestor has no recall.
Of its descendants, K042839 (Philips Medical Systems (Cleveland), Inc., 2004) has gone furthest, with 0 descendants of its own.
2 other devices also cite its predicate K930428.

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 Quest Positron Emission Tomography (PET) system is a whole body scanner designed to provide true volumetric imaging. Quest is intended for use as a diagnostic imaging device. When used with appropriate radiopharmaceuticals, it produces images representative of the internal distribution of radioactivity in the head or the body. PET is based on the fact that certain radionuclides decay by positron emission. The positron annihilation results in the…

Read the full statement (125 words)

The Quest Positron Emission Tomography (PET) system is a whole body scanner designed to provide true volumetric imaging.

Quest is intended for use as a diagnostic imaging device. When used with appropriate radiopharmaceuticals, it produces images representative of the internal distribution of radioactivity in the head or the body.

PET is based on the fact that certain radionuclides decay by positron emission. The positron annihilation results in the emission of two 511 keV gamma-rays which are emitted in opposite directions. Coincidence detection of both gamma rays localizes the decay along a line. By using 6 large position-sensitive detectors around the patient, counts along many parallel lines and at many angles are acquired simultaneously. By using reconstruction algorithms, the internal distribution of radioactivity can be determined.

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/K973396 · printed Nov 5, 2026

Cite this page

510(k) Report. “K973396: Quest Pet 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/K973396

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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