510(k) · Cleared

Cleared

E. Cam Profile Attenuation Correction

K963983510(k) TraditionalCleared Mar 31, 1997178-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 Corp. · KPS System, Tomography, Computed, Emission

Cleared on Mar 31, 1997 after a 178-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 6 of the 91 devices in its family, counting itself, have a Class I recall. 90 later devices descend from it.

Decided: Mar 31, 1997
Review: 178 days
Class: Class II
Product code: KPS
Recalls: None
Predicates: 0

90 later devices descend from it, 5 citing it directly. 6 of the 91 devices in this family, counting this one, have a Class I recall.

This deviceK963983 E. Cam Profile Attenuation CorrectionSiemens Corp. · 1997
Descendant · cites it directly · 86 of its ownK051460 C.Cam-ACDanish Diagnostic Development A/S · 2005 · Recalled
Descendant · cites it directly · 85 of its ownK072567 Symbia-E, Model 10275879Siemens Medical Solutions USA, Inc. · 2007 · Recalled
Descendant · 2 generations on · 83 of its ownK082506 Symbia, Version 4.0Siemens Medical Solutions USA, Inc. · 2008 · Recalled
Descendant · 3 generations on · 66 of its ownK131634 SymbiaSiemens Medical Solutions USA, Inc. · 2013 · Recalled
Descendant · 4 generations on · 65 of its ownK142006 Symbia 6.0Siemens Medical Solutions USA, Inc. · 2014 · Recalled

Showing 5 of 90 descendants. See all descendants

Descendants cleared per year

1998high 13 (2025) · low 0 (1999)2026

Class I recalls in this family

K093514 Discovery Model NM/CT 6703 generations on · 2009
K153402 Discovery NM/CT 670 CZT4 generations on · 2016
K173816 NM/CT 850, NM/CT 8604 generations on · 2018
K111445 Discovery NM 6304 generations on · 2011

Most influential descendants

Showing 5 of 90 · See all

K051460C.Cam-ACDanish Diagnostic Development A/S · 2005 · cites it directly86descendants
K072567Symbia-E, Model 10275879Siemens Medical Solutions USA, Inc. · 2007 · cites it directly85descendants
K082506Symbia, Version 4.0Siemens Medical Solutions USA, Inc. · 2008 · 2 generations on83descendants
K131634SymbiaSiemens Medical Solutions USA, Inc. · 2013 · 3 generations on66descendants
K142006Symbia 6.0Siemens Medical Solutions USA, Inc. · 2014 · 4 generations on65descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K963983	E. Cam Profile Attenuation Correction	Siemens Corp.	1997	—
+1	K051460	C.Cam-AC	Danish Diagnostic Development A/S	2005	1
+1	K072567	Symbia-E, Model 10275879	Siemens Medical Solutions USA, Inc.	2007	2
+2	K082506	Symbia, Version 4.0	Siemens Medical Solutions USA, Inc.	2008	9
+3	K131634	Symbia	Siemens Medical Solutions USA, Inc.	2013	7
+4	K142006	Symbia 6.0	Siemens Medical Solutions USA, Inc.	2014	9

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1998	2	0
2005	1	0
2007	1	0
2008	1	0
2009	1	1
2010	2	0
2011	3	2
2012	1	1
2013	2	0
2014	1	0
2016	2	1
2017	1	0
2018	4	1
2019	3	0
2020	4	0
2021	10	0
2022	7	0
2023	10	0
2024	10	0
2025	13	0
2026	11	0

FIG. 1 — Lineage of K963983, 1997–2026Source: 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.

6 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

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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? (90)

See all 90

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

Number	Device	Applicant	Decided	Descendants
K051460	C.Cam-AC	Danish Diagnostic Development A/S	2005	86
K072567	Symbia-E, Model 10275879	Siemens Medical Solutions USA, Inc.	2007	85
K101768	Mie Scintron Gamma Camera Systems	Miegmbh	2010	0
K983516	Transmission Kit, Trans-CT, Model NSTR-050A	Toshiba America Medical Systems, In.C	1998	0
K982300	Transview (Transmission System),Model NDTR-701A	Toshiba America Medical Systems, In.C	1998	0

Has anything in its family been recalled? (6 Class I)

No FDA recall names this device.

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 · 3 generations on · ◆ in the 2009 descendants bar of FIG. 12 Class I recalls
K153402Discovery NM/CT 670 CZTGE Healthcare · 2016 · 4 generations on · ◆ in the 2016 descendants bar of FIG. 11 Class I recall
K173816NM/CT 850, NM/CT 860GE Healthcare · 2018 · 4 generations on · ◆ in the 2018 descendants bar of FIG. 11 Class I recall
K111445Discovery NM 630GE Healthcare · 2011 · 4 generations on · ◆ in the 2011 descendants bar of FIG. 12 Class I recalls
K113350Brivo NM 615GE Healthcare · 2011 · 5 generations on · ◆ in the 2011 descendants bar of FIG. 12 Class I recalls
K121019Optima NM/CT 640GE Healthcare · 2012 · 5 generations on · ◆ in the 2012 descendants bar of FIG. 12 Class I recalls

Nearest 5 of 6; all are on the web page.

What does this lineage say?

Of its descendants, K051460 (Danish Diagnostic Development A/S, 2005) has gone furthest, with 86 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/K963983 · printed Nov 5, 2026

Cite this page

510(k) Report. “K963983: E. Cam Profile Attenuation Correction.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K963983

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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