510(k) · Cleared

Recalled · Class II · 2013

Siemens Enhanced Imaging System

K041166510(k) TraditionalCleared May 17, 200413-day reviewClass II21 CFR 892.1200Recalls 12

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 May 17, 2004 as substantially equivalent to K992731 (Siemens Medical Solutions USA, Inc., 1999) and 3 other predicates after a 13-day review. Its family tree reaches back 3 generations to 1995. 7 of the 96 devices in its family, counting itself, have a Class I recall. 87 later devices descend from it. It has been recalled 12 times.

Decided: May 17, 2004
Review: 13 days
Class: Class II
Product code: KPS
Recalls: 12
Predicates: 4

Its longest line of descent runs back 3 generations to K952674 (1995). 8 ancestors in all, the oldest K892358 (1989). 87 later devices descend from it, 3 citing it directly. 7 of the 96 devices in this family, counting this one, have a Class I recall.

By dateBy generation

Root · 3 generations backK952674 Transact: Attenuation Correction System for the Apex Cardial Gamma…Elscint, Inc. · 1995 · Recalled
2 generations backK980959 Vtransact: Attenuation Correction System for Dual-Head Variable…Ge Medical Systems F.I. Haifa · 1998
1 generation backK991841 Hawkeye Option for Dual-Head Variable Angle Gamma CameraGe Medical Systems F.I. Haifa · 1999 · Recalled (Class I)
This deviceK041166 Siemens Enhanced Imaging SystemSiemens Medical Solutions USA, Inc. · 2004
Descendant · cites it directly · 86 of its ownK063826 Syngo MI Applications 2007ASiemens Medical Solutions USA, Inc. · 2007
Descendant · cites it directly · 85 of its ownK072567 Symbia-E, Model 10275879Siemens Medical Solutions USA, Inc. · 2007 · Recalled
Descendant · cites it directly · 83 of its ownK082506 Symbia, Version 4.0Siemens Medical Solutions USA, Inc. · 2008 · Recalled
Descendant · 2 generations on · 66 of its ownK131634 SymbiaSiemens Medical Solutions USA, Inc. · 2013 · Recalled
Descendant · 3 generations on · 65 of its ownK142006 Symbia 6.0Siemens Medical Solutions USA, Inc. · 2014 · Recalled

Showing 5 of 87 descendants. See all descendants

Descendants cleared per year

2007high 13 (2025) · low 0 (2015)2026

Class I recalls in this family

K991841 Hawkeye Option for Dual-Head Variable Angle…direct predicate · 1999
K093514 Discovery Model NM/CT 6702 generations on · 2009
K153402 Discovery NM/CT 670 CZT3 generations on · 2016
K173816 NM/CT 850, NM/CT 8603 generations on · 2018

Most influential descendants

Showing 5 of 87 · See all

K063826Syngo MI Applications 2007ASiemens Medical Solutions USA, Inc. · 2007 · cites it directly86descendants
K072567Symbia-E, Model 10275879Siemens Medical Solutions USA, Inc. · 2007 · cites it directly85descendants
K082506Symbia, Version 4.0Siemens Medical Solutions USA, Inc. · 2008 · cites it directly83descendants
K131634SymbiaSiemens Medical Solutions USA, Inc. · 2013 · 2 generations on66descendants
K142006Symbia 6.0Siemens Medical Solutions USA, Inc. · 2014 · 3 generations on65descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K952674	Transact: Attenuation Correction System for the Apex Cardial Gamma Camera	Elscint, Inc.	1995	1
−2	K980959	Vtransact: Attenuation Correction System for Dual-Head Variable Angle Gamma…	Ge Medical Systems F.I. Haifa	1998	—
−1	K991841	Hawkeye Option for Dual-Head Variable Angle Gamma Camera	Ge Medical Systems F.I. Haifa	1999	Class I
0 (this device)	K041166	Siemens Enhanced Imaging System	Siemens Medical Solutions USA, Inc.	2004	—
+1	K063826	Syngo MI Applications 2007A	Siemens Medical Solutions USA, Inc.	2007	—
+1	K072567	Symbia-E, Model 10275879	Siemens Medical Solutions USA, Inc.	2007	2
+1	K082506	Symbia, Version 4.0	Siemens Medical Solutions USA, Inc.	2008	9
+2	K131634	Symbia	Siemens Medical Solutions USA, Inc.	2013	7
+3	K142006	Symbia 6.0	Siemens Medical Solutions USA, Inc.	2014	9

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1989	1	0
1991	1	0
1995	1	0
1999	1	0
2002	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2007	2	0
2008	1	0
2009	1	1
2010	1	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 K041166, 1995–2026Source: 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.

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? (4)

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
*	K992731	E.Cam Computer Summary page 1 …Modification of a legally marketed device Identification of Legally Marketed Equivalent Devices 510(k) Number Date of Clearance Device Name K992731 November 10, 1999 Siemens, e.Cam Computer K(952109 August 23, 1995 Siemens, tp 500 Nuclear Ga…	Siemens Medical Solutions USA, Inc.	1999	1
*	K952109	IP500 Nuclear Gamma Camera System Summary page 1 …ly Marketed Equivalent Devices 510(k) Number Date of Clearance Device Name K992731 November 10, 1999 Siemens, e.Cam Computer K(952109 August 23, 1995 Siemens, tp 500 Nuclear Gamma Camera System K…	Siemens Medical Solutions USA, Inc.	1995	7
*	K991841	Hawkeye Option for Dual-Head Variable Angle Gamma Camera Summary page 1 …Siemens, e.Cam Computer K(952109 August 23, 1995 Siemens, tp 500 Nuclear Gamma Camera System K991841 August 26, 1999 General Electric, Hawkeye Option for Dual-Head Vari…	Ge Medical Systems F.I. Haifa	1999	Class I
*	K023687	Somatom Emotion 6 CT Systems Summary page 1 …ral Electric, Hawkeye Option for Dual-Head Variable Angle Gamma Camera K023687 November 22, 2002 Siemens Somatomn CT System 510(k) Summary of Safety and Effecti…	Siemens Medical Systems, Inc.	2002	6

Also cleared against K992731: 4 other devices →

What descends from it? (87)

See all 87

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

Number	Device	Applicant	Decided	Descendants
K063826	Syngo MI Applications 2007A	Siemens Medical Solutions USA, Inc.	2007	86
K072567	Symbia-E, Model 10275879	Siemens Medical Solutions USA, Inc.	2007	85
K082506	Symbia, Version 4.0	Siemens Medical Solutions USA, Inc.	2008	83

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Aug 16, 2013	Class II	Z-0061-2017	Component design/selection	The detectors on the Symbia S and Symbia T camera systems are supported and moved horizontally and vertically by four linear bearing cars. There is a potential for the linear bearing car to fail allowing the ball bearings to fall out.
Oct 23, 2012	Class II	Z-1086-2015	Component design/selection	There is a potential for the linear bearing car to fail allowing the ball bearings to fall out.
Dec 11, 2009	Not classified	Z-0584-2010	Process control	Some of the hand controllers of the Symbia S & T systems are missing a resistor switch, and the absence of the switch may lead to unintended system motion during camera set up activities.
Dec 11, 2009	Not classified	Z-0583-2010	Process control	Some of the hand controllers of the Symbia S & T systems are missing a resistor switch, and the absence of the switch may lead to unintended system motion during camera set up activities.
Apr 22, 2009	Not classified	Z-1676-2009	Finished device change control	The pinion gear could crack and cause the gantry to spin freely thereby damaging the Symbia S or T System and potentially injuring a patient during a scan.
Apr 22, 2009	Not classified	Z-1677-2009	Finished device change control	The pinion gear could crack and cause the gantry to spin freely thereby damaging the Symbia S or T System and potentially injuring a patient during a scan.
Mar 11, 2009	Not classified	Z-1649-2009	Software design	Patient injury can occur when the patient is lying on the patient bed and the automatic collimator exchanger is undergoing a collimator change operation at the launch of an acquisition workflow. Detector motions required for this change…
Mar 11, 2009	Not classified	Z-1648-2009	Software design	Patient injury can occur when the patient is lying on the patient bed and the automatic collimator exchanger is undergoing a collimator change operation at the launch of an acquisition workflow. Detector motions required for this change…
Sep 29, 2008	Not classified	Z-0190-2009	Nonconforming Material/Component	The protective plastic cap over the CT gantry power switch on the Line Connection Box may come loose, exposing the energized electrical contacts within the switch, thereby causing an electric hazard.
Sep 29, 2008	Not classified	Z-0189-2009	Nonconforming Material/Component	The protective plastic cap over the CT gantry power switch on the Line Connection Box may come loose, exposing the energized electrical contacts within the switch, thereby causing an electric hazard.
Jan 30, 2007	Not classified	Z-0549-2007	Other	Symbia systems, running on e.soft version 5.5 or earlier, could allow a fully-extended patient pallet to come into contact with the pinhole collimator, resulting in system damage.
Jan 30, 2007	Not classified	Z-0548-2007	Other	Symbia systems, running on e.soft version 5.5 or earlier, could allow a fully-extended patient pallet to come into contact with the pinhole collimator, resulting in system damage.

The 5 latest of 12 recalls; the web page lists all.

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.

K991841Hawkeye Option for Dual-Head Variable Angle Gamma CameraGe Medical Systems F.I. Haifa · 1999 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall
K093514Discovery Model NM/CT 670Ge Medical Systems F.I. Haifa · 2009 · 2 generations on · ◆ in the 2009 descendants bar of FIG. 12 Class I recalls
K153402Discovery NM/CT 670 CZTGE Healthcare · 2016 · 3 generations on · ◆ in the 2016 descendants bar of FIG. 11 Class I recall
K173816NM/CT 850, NM/CT 860GE Healthcare · 2018 · 3 generations on · ◆ in the 2018 descendants bar of FIG. 11 Class I recall
K111445Discovery NM 630GE Healthcare · 2011 · 3 generations on · ◆ in the 2011 descendants bar of FIG. 12 Class I recalls
K113350Brivo NM 615GE Healthcare · 2011 · 4 generations on · ◆ in the 2011 descendants bar of FIG. 12 Class I recalls
K121019Optima NM/CT 640GE Healthcare · 2012 · 4 generations on · ◆ in the 2012 descendants bar of FIG. 12 Class I recalls

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

What does this lineage say?

The line of descent spans 9 years and passes through 3 companies; a new generation was cleared every 2.7 years on median.
6 of the 8 ancestors have a recall of any class; 1 has a Class I recall.
Of its descendants, K063826 (Siemens Medical Solutions USA, Inc., 2007) has gone furthest, with 86 descendants of its own.
4 other devices also cite its predicate K992731.

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?

SPECT: To detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging, tomographic imaging for isotopes with energies up to 588keV.

CT: The CT component is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial place taken at different angles or spiral planes taken at different angles.

SPECT+CT: Perform CT scans and nuclear imaging studies within the same instrument. To obtain attenuation corrected images and to provide registration of anatomical and physiological images within the patient's anatomy.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K041166 · printed Nov 6, 2026

Cite this page

510(k) Report. “K041166: Siemens Enhanced Imaging System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K041166

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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