510(k) · Cleared

Recalled · 2004

Ecat Pet Scanner

K002715510(k) TraditionalCleared Oct 31, 200061-day reviewClass II21 CFR 892.1200Recalls 2

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Cti Pet Systems, Inc. · KPS System, Tomography, Computed, Emission

Cleared on Oct 31, 2000 after a 61-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 7 of the 272 devices in its family, counting itself, have a Class I recall. 271 later devices descend from it. It has been recalled 2 times.

Decided: Oct 31, 2000
Review: 61 days
Class: Class II
Product code: KPS
Recalls: 2
Predicates: 0

271 later devices descend from it, 6 citing it directly. 7 of the 272 devices in this family, counting this one, have a Class I recall.

This deviceK002715 Ecat Pet ScannerCti Pet Systems, Inc. · 2000
Descendant · cites it directly · 104 of its ownK023190 E.Cam Computer / E.Soft WorkstationSiemens Medical Solutions USA, Inc. · 2002
Descendant · cites it directly · 88 of its ownK013521 Gemini Imaging SystemAdac Laboratories · 2001 · Recalled
Descendant · 2 generations on · 87 of its ownK032036 Gemini 16Philips Medical Systems (Cleveland), Inc. · 2003 · Recalled
Descendant · 2 generations on · 86 of its ownK063826 Syngo MI Applications 2007ASiemens Medical Solutions USA, Inc. · 2007
Descendant · 3 generations on · 85 of its ownK072567 Symbia-E, Model 10275879Siemens Medical Solutions USA, Inc. · 2007 · Recalled

Showing 5 of 271 descendants. See all descendants

Descendants cleared per year

2001high 28 (2025) · low 2 (2001)2026

Class I recalls in this family

K093514 Discovery Model NM/CT 6704 generations on · 2009
K153402 Discovery NM/CT 670 CZT5 generations on · 2016
K173816 NM/CT 850, NM/CT 8605 generations on · 2018
K111445 Discovery NM 6305 generations on · 2011

Most influential descendants

Showing 5 of 271 · See all

K023190E.Cam Computer / E.Soft WorkstationSiemens Medical Solutions USA, Inc. · 2002 · cites it directly104descendants
K013521Gemini Imaging SystemAdac Laboratories · 2001 · cites it directly88descendants
K032036Gemini 16Philips Medical Systems (Cleveland), Inc. · 2003 · 2 generations on87descendants
K063826Syngo MI Applications 2007ASiemens Medical Solutions USA, Inc. · 2007 · 2 generations on86descendants
K072567Symbia-E, Model 10275879Siemens Medical Solutions USA, Inc. · 2007 · 3 generations on85descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K002715	Ecat Pet Scanner	Cti Pet Systems, Inc.	2000	—
+1	K023190	E.Cam Computer / E.Soft Workstation	Siemens Medical Solutions USA, Inc.	2002	—
+1	K013521	Gemini Imaging System	Adac Laboratories	2001	2
+2	K032036	Gemini 16	Philips Medical Systems (Cleveland), Inc.	2003	2
+2	K063826	Syngo MI Applications 2007A	Siemens Medical Solutions USA, Inc.	2007	—
+3	K072567	Symbia-E, Model 10275879	Siemens Medical Solutions USA, Inc.	2007	2

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2001	2	0
2002	4	0
2003	3	0
2004	5	0
2005	3	0
2006	4	0
2007	4	0
2008	6	0
2009	3	1
2010	6	0
2011	7	2
2012	5	1
2013	7	0
2014	10	0
2015	3	0
2016	7	1
2017	11	0
2018	18	1
2019	7	0
2020	17	1
2021	20	0
2022	18	0
2023	23	0
2024	23	0
2025	28	0
2026	27	0

FIG. 1 — Lineage of K002715, 2000–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

7 devices in this family have a Class I recall. 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

Get a 510(k) Report

What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (271)

See all 271

6 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K023190	E.Cam Computer / E.Soft Workstation	Siemens Medical Solutions USA, Inc.	2002	104
K013521	Gemini Imaging System	Adac Laboratories	2001	88
K013504	Modification to: Ecat Lso Pet/CT Scanner	Cti Pet Systems, Inc.	2001	73
K032063	Pem 2400 Pet Scanner	Pem Technologies	2003	2
K023768	Ecat Pet/CT; Ecat Lso Pet/CT; Ecat Lso Pet/CT 16	Cti Pet Systems, Inc.	2002	1
K021633	Ecat Vision Pet Scanner, Models 3000 & 5000	Cti Pet Systems, Inc.	2002	0

Has anything in its family been recalled? (7 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
May 27, 2004	Not classified	Z-0547-05	Other	Misalignment of CT and PET scans from performing additional CT scans may produce an incorrect fused data set. In performing additional CT scans, the original PET and CT scans may become misaligned and produce an incorrect fused data set.
Oct 2, 2003	Not classified	Z-0106-04	Other	CPS has found that in some instances, when the CT E-Stop is activated, a malfunction may occur where the PHS controller may not shut down and stop bed motion.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

K093514Discovery Model NM/CT 670Ge Medical Systems F.I. Haifa · 2009 · 4 generations on · ◆ in the 2009 descendants bar of FIG. 12 Class I recalls
K153402Discovery NM/CT 670 CZTGE Healthcare · 2016 · 5 generations on · ◆ in the 2016 descendants bar of FIG. 11 Class I recall
K173816NM/CT 850, NM/CT 860GE Healthcare · 2018 · 5 generations on · ◆ in the 2018 descendants bar of FIG. 11 Class I recall
K111445Discovery NM 630GE Healthcare · 2011 · 5 generations on · ◆ in the 2011 descendants bar of FIG. 12 Class I recalls
K113350Brivo NM 615GE Healthcare · 2011 · 6 generations on · ◆ in the 2011 descendants bar of FIG. 12 Class I recalls
K121019Optima NM/CT 640GE Healthcare · 2012 · 6 generations on · ◆ in the 2012 descendants bar of FIG. 12 Class I recalls
K200213Biograph mMR with syngo MR E11P-AP01 system softwareSiemens Medical Solutions USA, Inc. · 2020 · 9 generations on · ◆ in the 2020 descendants bar of FIG. 11 Class I recall

Nearest 5 of 7; all are on the web page.

What does this lineage say?

Of its descendants, K023190 (Siemens Medical Solutions USA, Inc., 2002) has gone furthest, with 104 descendants of its own.

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	—

https://510kreport.com/device/K002715 · printed Nov 6, 2026

Cite this page

510(k) Report. “K002715: Ecat Pet Scanner.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K002715

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Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026