510(k) · Cleared

Cleared

Ecat Scintron Pet

K130269510(k) TraditionalCleared Apr 19, 201374-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

Miegmbh · KPS System, Tomography, Computed, Emission

Cleared on Apr 19, 2013 as substantially equivalent to K962797 (Cti Pet Systems, Inc., 1996) and 1 other predicate after a 74-day review. Its family tree reaches back 1 generation to 1996. 1 later device descends from it.

Decided: Apr 19, 2013
Review: 74 days
Class: Class II
Product code: KPS
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K962797 (1996). 2 ancestors in all. 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK962797 Ecat Exact & Ecat Exact HR+Cti Pet Systems, Inc. · 1996 · Recalled
This deviceK130269 Ecat Scintron PetMiegmbh · 2013
Descendant · cites it directly · 0 of its ownK201807 AncorisMiegmbh · 2020

Most influential descendants

Showing 1 of 1 · See all

K201807AncorisMiegmbh · 2020 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K962797	Ecat Exact & Ecat Exact HR+	Cti Pet Systems, Inc.	1996	14
0 (this device)	K130269	Ecat Scintron Pet	Miegmbh	2013	—
+1	K201807	Ancoris	Miegmbh	2020	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2000	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2020	1	0

FIG. 1 — Lineage of K130269, 1996–2020Source: 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
*	K962797	Ecat Exact & Ecat Exact HR+ Summary page 3 …) Device Comparison The integrated workstation 'ECAT SCINTRON PET' is similar to the integrated workstation of the PET Scanner, name ECAT EXACT PET System, K962797 and name ECAT ACCEL PET Scanner, K002584. This involves all computer applications as well hardware interfaces. The ma…	Cti Pet Systems, Inc.	1996	14
*	K002584	Ecat Accel Pet Scanner Summary page 1 …(k) # Device Manufacturer K<962797 ECAT EXACT PET System CTI PET Systems, Inc. K002584 ECAT ACCEL PET Scanner CTI PET Systems, Inc. 05 SCINTRON PET Summiary 2012-1 1-20.doc /TK…	Cti Pet Systems, Inc.	2000	14

Also cleared against K962797: 4 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
K201807	Ancoris	Miegmbh	2020	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?

2 of the 2 ancestors have a recall of any class.
Of its descendants, K201807 (Miegmbh, 2020) has gone furthest, with 0 descendants of its own.
4 other devices also cite its predicate K962797.

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. 2013, this device’s year, is highlighted.

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 'ECAT Scintron PET' integrated workstation is designed to acquire data, process and display images, by appropriated trained health care professionals, from ECAT EXACT and ECAT ACCEL PET scanners of CTI PET Systems via measuring the distribution of injected positron emitting radiopharmaceutical in humans for purpose of determining various metabolic and physiologic functions within the human body.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K130269 · printed Nov 6, 2026

Cite this page

510(k) Report. “K130269: Ecat Scintron Pet.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130269

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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