510(k) · Cleared

Recalled · 2007

C.CAM

K031825510(k) AbbreviatedCleared Jun 20, 20037-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

Danish Diagnostic Development A/S · KPS System, Tomography, Computed, Emission

Cleared on Jun 20, 2003 as substantially equivalent to K011611 (Danish Diagnostic Development A/S, 2001) and 1 other predicate after a 7-day review. Its family tree reaches back 1 generation to 2000. 6 of the 101 devices in its family, counting itself, have a Class I recall. 98 later devices descend from it. It has been recalled 2 times.

Decided: Jun 20, 2003
Review: 7 days
Class: Class II
Product code: KPS
Recalls: 2
Predicates: 2

Its longest line of descent runs back 1 generation to K001888 (2000). 2 ancestors in all. 98 later devices descend from it, 3 citing it directly. 6 of the 101 devices in this family, counting this one, have a Class I recall.

By dateBy generation

Root · 1 generation backK001888 Unicorn Model SYS0630Danish Diagnostic Development A/S · 2000
This deviceK031825 C.CAMDanish Diagnostic Development A/S · 2003
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
Descendant · 5 generations on · 63 of its ownK162483 Symbia Intevo BoldSiemens Medical Solutions USA, Inc. · 2017

Showing 5 of 98 descendants. See all descendants

Descendants cleared per year

2006high 14 (2025) · low 0 (2015)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 98 · See all

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
K162483Symbia Intevo BoldSiemens Medical Solutions USA, Inc. · 2017 · 5 generations on63descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K001888	Unicorn Model SYS0630	Danish Diagnostic Development A/S	2000	—
0 (this device)	K031825	C.CAM	Danish Diagnostic Development A/S	2003	—
+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
+5	K162483	Symbia Intevo Bold	Siemens Medical Solutions USA, Inc.	2017	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2001	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2006	2	0
2007	2	0
2008	3	0
2009	1	1
2010	1	0
2011	4	2
2012	1	1
2013	2	0
2014	1	0
2016	4	1
2017	1	0
2018	5	1
2019	3	0
2020	4	0
2021	12	0
2022	7	0
2023	10	0
2024	10	0
2025	14	0
2026	11	0

FIG. 1 — Lineage of K031825, 2000–2026Source: 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.

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

Get a 510(k) Report

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
*	K011611	Cardiocam Model 9CSY0799	Danish Diagnostic Development A/S	2001	1
*	K001888	Unicorn Model SYS0630 Summary page 1 …c Development N S , CardioMD 5 1O(K) Number: KO11611 3D, Danish Diagnostic Development N S , Unicorn (K001888) Refer to section C3 Comparison of the New and Predicate Device, subpart;…	Danish Diagnostic Development A/S	2000	—

Also cleared against K011611: 2 other devices →

What descends from it? (98)

See all 98

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

Number	Device	Applicant	Decided	Descendants
K072567	Symbia-E, Model 10275879	Siemens Medical Solutions USA, Inc.	2007	85
K062450	D-Spect Cardiac Scanner System	Spectrum Dynamics, Ltd.	2006	14
K060486	Cyclone, Model Maicam 180	Spectrica	2006	0

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Sep 17, 2007	Not classified	Z-0304-2008	Software design	Unintended Motion: A hardware fault in the c.cam system can cause the system to experience unintended motion, thereby causing a collision hazard.
Apr 30, 2007	Not classified	Z-0906-2007	Other	Chair Breakage: Under extreme load, the chair back of the c.cam emission computed tomography system may bend and eventually break. This could be caused by the accumulated stress from heavy patients seating or stretching themselves in the…

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?

1 of the 2 ancestors has a recall of any class.
Of its descendants, K072567 (Siemens Medical Solutions USA, Inc., 2007) has gone furthest, with 85 descendants of its own.
2 other devices also cite its predicate K011611.

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?

Virgo is an emission computed tomography system intended to detect the location and distribution of gamma ray radionuclides in the body and produce cross-sectional images through computer reconstruction of the data The device includes display equipment, patient and equipment supports, component parts, and accessories. Virgo is primarily intended for cardiac applications but the Virgo design also supports non-cardiac procedures of the patient’s chest region and body extremities. Virgo supports radionuclides within the energy range of 60 - 170 keV

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K031825 · printed Nov 6, 2026

Cite this page

510(k) Report. “K031825: C.CAM.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031825

Report an extraction error

Are you the manufacturer?

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