510(k) · Cleared

Cleared

GE Positrace/Discovery VI Pet/CT Dual Mode Oncology Scanner

K012775510(k) SpecialCleared Sep 18, 200129-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

GE Medical Systems · KPS System, Tomography, Computed, Emission

Cleared on Sep 18, 2001 as substantially equivalent to K001681 (Smv America, 2000) after a 29-day review. Its family tree reaches back 1 generation to 2000.

Decided: Sep 18, 2001
Review: 29 days
Class: Class II
Product code: KPS
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K001681 (2000). No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK001681 Positrace Dual Mode Pet/CT Oncology SystemSmv America · 2000
This deviceK012775 GE Positrace/Discovery VI Pet/CT Dual Mode Oncology ScannerGE Medical Systems · 2001

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K001681	Positrace Dual Mode Pet/CT Oncology System	Smv America	2000	—
0 (this device)	K012775	GE Positrace/Discovery VI Pet/CT Dual Mode Oncology Scanner	GE Medical Systems	2001	—

FIG. 1 — Lineage of K012775, 2000–2001Source: 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 18.7 · 17 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
*	K001681	Positrace Dual Mode Pet/CT Oncology System Summary page 1 …Dual Mode PET/CT Oncology System Emission Computed Tomography System, 21 CFR 892.1200, 90-KPS Marketed Device: Positrace Dual Mode PET/CT Oncology System, 510(k) Number K001681, currently in commercial distribution. Device Description: The Positrace / Discovery VI PET/CT scanner is a whole-body scanner p…	Smv America	2000	—

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?

Its one ancestor has no 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?

Combination of whole-body positron emission tomography (PET) scanning with a diagnostic quality computed tomography scanner. Intended for use as a diagnostic imaging device. Used with appropriate radiopharmaceuticals, it produces images which depict the anatomical distribution of radicisotopes within the human body. The integrated CT system is intended to provide an enhancement to the emission images by compensating for the attenuation effects of the human body. It will also provide registration of anatomical and physiological images to localize the radioisotope activity in the patient anatomy. The CT or PET scanner may be used independently.

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/K012775 · printed Nov 4, 2026

Cite this page

510(k) Report. “K012775: GE Positrace/Discovery VI Pet/CT Dual Mode Oncology Scanner.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K012775

Report an extraction error

Are you the manufacturer?

Record history

FDA decision record loaded May 2, 2026
Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026