510(k) · Cleared

Cleared

ImagenSPECT

K152503510(k) TraditionalCleared Jan 25, 2016145-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

Cardiovascular Imaging Technologies · KPS System, Tomography, Computed, Emission

Cleared on Jan 25, 2016 as substantially equivalent to K061029 (Adac Laboratories, 2006) and 2 other predicates after a 145-day review. Its family tree reaches back 4 generations to 1995. 1 of the 17 devices in its family, counting itself, has a Class I recall. 1 later device descends from it.

Decided: Jan 25, 2016
Review: 145 days
Class: Class II
Product code: KPS
Recalls: None
Predicates: 3

Its longest line of descent runs back 4 generations to K952674 (1995). 15 ancestors in all, the oldest K892358 (1989). 1 later device descends from it, 1 citing it directly. 1 of the 17 devices in this family, counting this one, has a Class I recall.

By dateBy generation

Root · 4 generations backK952674 Transact: Attenuation Correction System for the Apex Cardial Gamma…Elscint, Inc. · 1995 · Recalled
3 generations backK980959 Vtransact: Attenuation Correction System for Dual-Head Variable…Ge Medical Systems F.I. Haifa · 1998
2 generations backK991841 Hawkeye Option for Dual-Head Variable Angle Gamma CameraGe Medical Systems F.I. Haifa · 1999 · Recalled (Class I)
1 generation backK023190 E.Cam Computer / E.Soft WorkstationSiemens Medical Solutions USA, Inc. · 2002
This deviceK152503 ImagenSPECTCardiovascular Imaging Technologies · 2016
Descendant · cites it directly · 0 of its ownK201933 ImagenSPECT 3.0Cardiovascular Imaging Technologies · 2020

Class I recalls in this family

K991841 Hawkeye Option for Dual-Head Variable Angle…2 generations back · 1999

Most influential descendants

Showing 1 of 1 · See all

K201933ImagenSPECT 3.0Cardiovascular Imaging Technologies · 2020 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−4	K952674	Transact: Attenuation Correction System for the Apex Cardial Gamma Camera	Elscint, Inc.	1995	1
−3	K980959	Vtransact: Attenuation Correction System for Dual-Head Variable Angle Gamma…	Ge Medical Systems F.I. Haifa	1998	—
−2	K991841	Hawkeye Option for Dual-Head Variable Angle Gamma Camera	Ge Medical Systems F.I. Haifa	1999	Class I
−1	K023190	E.Cam Computer / E.Soft Workstation	Siemens Medical Solutions USA, Inc.	2002	—
0 (this device)	K152503	ImagenSPECT	Cardiovascular Imaging Technologies	2016	—
+1	K201933	ImagenSPECT 3.0	Cardiovascular Imaging Technologies	2020	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1989	1	0
1991	1	0
1995	1	0
1999	2	0
2000	2	0
2004	2	0
2006	1	0
2009	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2020	1	0

FIG. 1 — Lineage of K152503, 1995–2020Source: 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.

1 device in this family has 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? (3)

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
*	K061029	Jetstream Workspace Summary page 4 …September 1, 2015 ImagenSPECT™ System, Emission Computed Tomography 21 CFR 892.1200 (KPS) System, Image Processing, Radiological 21 CFR 892.2050 (LLZ) ADAC JETStream (k061029) Siemens e.Cam Computer/e.Soft Workstation (k023190) Philips AutoSPECT with Astonish (k090403) ImagenSPECT™ is a Windows appli…	Adac Laboratories	2006	1
*	K023190	E.Cam Computer / E.Soft Workstation Summary page 4 …uted Tomography 21 CFR 892.1200 (KPS) System, Image Processing, Radiological 21 CFR 892.2050 (LLZ) ADAC JETStream (k061029) Siemens e.Cam Computer/e.Soft Workstation (k023190) Philips AutoSPECT with Astonish (k090403) ImagenSPECT™ is a Windows application which allows physicians and healthcare profess…	Siemens Medical Solutions USA, Inc.	2002	—
*	K090403	Autospect Summary page 4 …em, Image Processing, Radiological 21 CFR 892.2050 (LLZ) ADAC JETStream (k061029) Siemens e.Cam Computer/e.Soft Workstation (k023190) Philips AutoSPECT with Astonish (k090403) ImagenSPECT™ is a Windows application which allows physicians and healthcare professionals to inspect, reconstruct and reorient…	Philips Medical Systems (Cleveland), Inc.	2009	2

Also cleared against K061029: 2 other devices →

What descends from it? (1)

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

Number	Device	Applicant	Decided	Descendants
K201933	ImagenSPECT 3.0	Cardiovascular Imaging Technologies	2020	0

Has anything in its family been recalled? (1 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.

K991841Hawkeye Option for Dual-Head Variable Angle Gamma CameraGe Medical Systems F.I. Haifa · 1999 · 2 generations back · ◆ on the line of descent in FIG. 11 Class I recall

What does this lineage say?

The line of descent spans 21 years and passes through 4 companies; a new generation was cleared every 3.2 years on median.
9 of the 15 ancestors have a recall of any class; 1 has a Class I recall.
Of its descendants, K201933 (Cardiovascular Imaging Technologies, 2020) has gone furthest, with 0 descendants of its own.
2 other devices also cite its predicate K061029.

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. 2016, this device’s year, is highlighted.

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?

The ImagenSPECT™ system is a software application that provides a processing environment for the analysis and display of cardiac SPECT images. The results of this processing may be used in determining the presence of cardiac diseases. Data for ImagenSPECT is derived from a nuclear medicine gamma camera. The resulting datasets may be either planar or 3D tomograms of patient anatomy.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K152503 · printed Nov 6, 2026

Cite this page

510(k) Report. “K152503: ImagenSPECT.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K152503

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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