510(k) · Cleared

Cleared

E. Cam Coincidence Mode (CM)

K970627510(k) TraditionalCleared Sep 4, 1997197-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

Siemens Medical Solutions USA, Inc. · KPS System, Tomography, Computed, Emission

Cleared on Sep 4, 1997 after a 197-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 3 later devices descend from it.

Decided: Sep 4, 1997
Review: 197 days
Class: Class II
Product code: KPS
Recalls: None
Predicates: 0

3 later devices descend from it, 1 citing it directly.

This deviceK970627 E. Cam Coincidence Mode (CM)Siemens Medical Solutions USA, Inc. · 1997
Descendant · cites it directly · 2 of its ownK981027 E.Cam Lso 311 Pet/Spect SystemCti Pet Systems, Inc. · 1998
Descendant · 2 generations on · 0 of its ownK040933 Ecat HRRTCti Pet Systems, Inc. · 2004
Descendant · 2 generations on · 0 of its ownK021633 Ecat Vision Pet Scanner, Models 3000 & 5000Cti Pet Systems, Inc. · 2002

Most influential descendants

Showing 3 of 3 · See all

K981027E.Cam Lso 311 Pet/Spect SystemCti Pet Systems, Inc. · 1998 · cites it directly2descendants
K040933Ecat HRRTCti Pet Systems, Inc. · 2004 · 2 generations on0descendants
K021633Ecat Vision Pet Scanner, Models 3000 & 5000Cti Pet Systems, Inc. · 2002 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K970627	E. Cam Coincidence Mode (CM)	Siemens Medical Solutions USA, Inc.	1997	—
+1	K981027	E.Cam Lso 311 Pet/Spect System	Cti Pet Systems, Inc.	1998	—
+2	K040933	Ecat HRRT	Cti Pet Systems, Inc.	2004	—
+2	K021633	Ecat Vision Pet Scanner, Models 3000 & 5000	Cti Pet Systems, Inc.	2002	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1998	1	0
2002	1	0
2004	1	0

FIG. 1 — Lineage of K970627, 1997–2004Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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

Get a 510(k) Report

What was it cleared against?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (3)

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

Number	Device	Applicant	Decided	Descendants
K981027	E.Cam Lso 311 Pet/Spect System	Cti Pet Systems, Inc.	1998	2

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?

Of its descendants, K981027 (Cti Pet Systems, Inc., 1998) has gone furthest, with 2 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	—

What is it indicated for?

To detect or image the distribution of radionuclides in the body or organ using the following technique(s).

Planar Imaging

Whole Body Imaging

Tomographic Imaging (SPECT) for non Positron emitter

Positron imaging by coincidence

Positron imaging without coincidence

Positron Whole Body Imaging by coincidence

Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K970627 · printed Nov 5, 2026

Cite this page

510(k) Report. “K970627: E. Cam Coincidence Mode (CM).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K970627

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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