510(k) · Cleared

Cleared

Vtransact: Attenuation Correction System for Dual-Head Variable Angle Gamma Camera

K980959510(k) TraditionalCleared Jun 4, 199882-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

Ge Medical Systems F.I. Haifa · KPS System, Tomography, Computed, Emission

Cleared on Jun 4, 1998 as substantially equivalent to K952674 (Elscint, Inc., 1995) after an 82-day review. Its family tree reaches back 1 generation to 1995. 10 of the 125 devices in its family, counting itself, have a Class I recall. 123 later devices descend from it.

Decided: Jun 4, 1998
Review: 82 days
Class: Class II
Product code: KPS
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K952674 (1995). 123 later devices descend from it, 3 citing it directly. 10 of the 125 devices in this family, counting this one, have a Class I recall.

By dateBy generation

Root · 1 generation backK952674 Transact: Attenuation Correction System for the Apex Cardial Gamma…Elscint, Inc. · 1995 · Recalled
This deviceK980959 Vtransact: Attenuation Correction System for Dual-Head Variable…Ge Medical Systems F.I. Haifa · 1998
Descendant · cites it directly · 120 of its ownK991841 Hawkeye Option for Dual-Head Variable Angle Gamma CameraGe Medical Systems F.I. Haifa · 1999 · Recalled (Class I)
Descendant · 2 generations on · 104 of its ownK023190 E.Cam Computer / E.Soft WorkstationSiemens Medical Solutions USA, Inc. · 2002
Descendant · 2 generations on · 87 of its ownK041166 Siemens Enhanced Imaging SystemSiemens Medical Solutions USA, Inc. · 2004 · Recalled
Descendant · 3 generations on · 86 of its ownK063826 Syngo MI Applications 2007ASiemens Medical Solutions USA, Inc. · 2007
Descendant · 3 generations on · 85 of its ownK072567 Symbia-E, Model 10275879Siemens Medical Solutions USA, Inc. · 2007 · Recalled

Showing 5 of 123 descendants. See all descendants

Descendants cleared per year

1999high 14 (2025) · low 0 (2001)2026

Class I recalls in this family

K991841 Hawkeye Option for Dual-Head Variable Angle…cites it directly · 1999
K022960 GE Quasar Nuclear Medicine System2 generations on · 2002
K052434 Hawkeye 4 Option for Dual-Head Variable Angle…2 generations on · 2005
K093514 Discovery Model NM/CT 6703 generations on · 2009

Most influential descendants

Showing 5 of 123 · See all

K991841Hawkeye Option for Dual-Head Variable Angle Gamma CameraGe Medical Systems F.I. Haifa · 1999 · cites it directly120descendants
K023190E.Cam Computer / E.Soft WorkstationSiemens Medical Solutions USA, Inc. · 2002 · 2 generations on104descendants
K041166Siemens Enhanced Imaging SystemSiemens Medical Solutions USA, Inc. · 2004 · 2 generations on87descendants
K063826Syngo MI Applications 2007ASiemens Medical Solutions USA, Inc. · 2007 · 3 generations on86descendants
K072567Symbia-E, Model 10275879Siemens Medical Solutions USA, Inc. · 2007 · 3 generations on85descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K952674	Transact: Attenuation Correction System for the Apex Cardial Gamma Camera	Elscint, Inc.	1995	1
0 (this device)	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
+2	K023190	E.Cam Computer / E.Soft Workstation	Siemens Medical Solutions USA, Inc.	2002	—
+2	K041166	Siemens Enhanced Imaging System	Siemens Medical Solutions USA, Inc.	2004	12
+3	K063826	Syngo MI Applications 2007A	Siemens Medical Solutions USA, Inc.	2007	—
+3	K072567	Symbia-E, Model 10275879	Siemens Medical Solutions USA, Inc.	2007	2

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1999	2	1
2000	1	0
2002	2	1
2004	2	0
2005	2	1
2007	3	0
2008	4	1
2009	2	1
2010	5	0
2011	4	2
2012	2	1
2013	4	0
2014	1	0
2015	1	0
2016	4	1
2017	2	0
2018	6	1
2019	3	0
2020	6	0
2021	12	0
2022	7	0
2023	12	0
2024	10	0
2025	14	0
2026	12	0

FIG. 1 — Lineage of K980959, 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.

10 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 18.7 · 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? (1)

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
*	K952674	Transact: Attenuation Correction System for the Apex Cardial Gamma Camera Summary page 1 …510(k) Submission Modification of legally marketed device. Identification of Legally Marketed Equivalent Devices TransACT option for the Apex Cardial. Gamma Camera - K952674 Device Description The VTransACT attenuation correction system is an addition to the Apex VariCam and Millennium VG gamma camer…	Elscint, Inc.	1995	1

Also cleared against K952674: 1 other device →

What descends from it? (123)

See all 123

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

Number	Device	Applicant	Decided	Descendants
K991841	Hawkeye Option for Dual-Head Variable Angle Gamma Camera Class I	Ge Medical Systems F.I. Haifa	1999	120
K994167	Code AC: Attenuation Correction System for Dual-Head Variable-Angle Gamma Camera with…	Ge Medical Systems F.I. Haifa	2000	0
K991896	MG Atc: Attenuation Correction System for Dual-Head Variable-Angle Gamma Camera	Ge Medical Systems F.I. Haifa	1999	0

Has anything in its family been recalled? (10 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 · Cites it directly · ◆ in the 1999 descendants bar of FIG. 11 Class I recall
K022960GE Quasar Nuclear Medicine SystemGe Medical Systems F.I. Haifa · 2002 · 2 generations on · ◆ in the 2002 descendants bar of FIG. 11 Class I recall
K052434Hawkeye 4 Option for Dual-Head Variable Angle Gamma CameraGE Medical Systems · 2005 · 2 generations on · ◆ in the 2005 descendants bar of FIG. 11 Class I recall
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
K080927Brightview VCT Imaging SystemPhilips Medical Systems (Cleveland), Inc. · 2008 · 3 generations on · ◆ in the 2008 descendants bar of FIG. 12 Class I recalls
K121019Optima NM/CT 640GE Healthcare · 2012 · 3 generations on · ◆ in the 2012 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

Nearest 5 of 10; all are on the web page.

What does this lineage say?

Its one ancestor has a recall.
Of its descendants, K991841 (Ge Medical Systems F.I. Haifa, 1999) has gone furthest, with 120 descendants of its own.
1 other device also cites its predicate K952674.

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 obtain attenuation corrected Nuclear Medicine images.

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/K980959 · printed Nov 4, 2026

Cite this page

510(k) Report. “K980959: Vtransact: Attenuation Correction System for Dual-Head Variable Angle Gamma Camera.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K980959

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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