510(k) · Cleared

Recalled · Class I · 2014

Hawkeye 4 Option for Dual-Head Variable Angle Gamma Camera

K052434510(k) SpecialCleared Sep 27, 200521-day reviewClass II21 CFR 892.1200Recalls 8 (1 Class I)

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

GE Medical Systems · KPS System, Tomography, Computed, Emission

Cleared on Sep 27, 2005 as substantially equivalent to K991841 (Ge Medical Systems F.I. Haifa, 1999) after a 21-day review. Its family tree reaches back 3 generations to 1995. 9 of the 20 devices in its family, counting itself, have a Class I recall. 16 later devices descend from it. It has been recalled 8 times, including a Class I recall.

Decided: Sep 27, 2005
Review: 21 days
Class: Class II
Product code: KPS
Recalls: 8 (1 Class I)
Predicates: 1

Its longest line of descent runs back 3 generations to K952674 (1995). 16 later devices descend from it, 3 citing it directly. 9 of the 20 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 deviceK052434 Hawkeye 4 Option for Dual-Head Variable Angle Gamma CameraGE Medical Systems · 2005
Descendant · cites it directly · 13 of its ownK093514 Discovery Model NM/CT 670Ge Medical Systems F.I. Haifa · 2009 · Recalled (Class I)
Descendant · 2 generations on · 6 of its ownK153402 Discovery NM/CT 670 CZTGE Healthcare · 2016 · Recalled (Class I)
Descendant · 3 generations on · 3 of its ownK182484 VERITON CT whole body SPECT/CT systemSpectrum Dynamics Medical, Ltd. · 2018
Descendant · 4 generations on · 2 of its ownK190457 VERITON CT whole body SPECT/CT systemSpectrum Dynamics Medical, Ltd. · 2019
Descendant · 2 generations on · 2 of its ownK111445 Discovery NM 630GE Healthcare · 2011 · Recalled (Class I)

Showing 5 of 16 descendants. See all descendants

Descendants cleared per year

2008high 3 (2025) · low 0 (2010)2026

Class I recalls in this family

K991841 Hawkeye Option for Dual-Head Variable Angle…direct predicate · 1999
K080927 Brightview VCT Imaging Systemcites it directly · 2008
K093514 Discovery Model NM/CT 670cites it directly · 2009
K121019 Optima NM/CT 640cites it directly · 2012

Most influential descendants

Showing 5 of 16 · See all

K093514Discovery Model NM/CT 670Ge Medical Systems F.I. Haifa · 2009 · cites it directly13descendants
K153402Discovery NM/CT 670 CZTGE Healthcare · 2016 · 2 generations on6descendants
K182484VERITON CT whole body SPECT/CT systemSpectrum Dynamics Medical, Ltd. · 2018 · 3 generations on3descendants
K190457VERITON CT whole body SPECT/CT systemSpectrum Dynamics Medical, Ltd. · 2019 · 4 generations on2descendants
K111445Discovery NM 630GE Healthcare · 2011 · 2 generations on2descendants

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)	K052434	Hawkeye 4 Option for Dual-Head Variable Angle Gamma Camera	GE Medical Systems	2005	—
+1	K093514	Discovery Model NM/CT 670	Ge Medical Systems F.I. Haifa	2009	Class I
+2	K153402	Discovery NM/CT 670 CZT	GE Healthcare	2016	Class I
+3	K182484	VERITON CT whole body SPECT/CT system	Spectrum Dynamics Medical, Ltd.	2018	—
+4	K190457	VERITON CT whole body SPECT/CT system	Spectrum Dynamics Medical, Ltd.	2019	—
+2	K111445	Discovery NM 630	GE Healthcare	2011	Class I

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2008	1	1
2009	2	1
2011	2	2
2012	1	1
2016	1	1
2018	2	1
2019	1	0
2021	1	0
2023	1	0
2025	3	0
2026	1	0

FIG. 1 — Lineage of K052434, 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.

9 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? (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
*	K991841	Hawkeye Option for Dual-Head Variable Angle Gamma Camera Summary page 2 …Head Variable Angle Gamma Camera" , Radiological, 21 CFR 892.1200, 90-KPS Marketed Device: "Hawkeye Option for Dual-Head Variable Angle Gamma Camera" -K991841 Radiological, 21 CFR 892.1200, 90-KPS Device Description: The "Hawkeye 4 Option" is a modification of the "Ha…	Ge Medical Systems F.I. Haifa	1999	Class I

Also cleared against K991841: 5 other devices →

What descends from it? (16)

See all 16

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

Number	Device	Applicant	Decided	Descendants
K093514	Discovery Model NM/CT 670 Class I	Ge Medical Systems F.I. Haifa	2009	13
K080927	Brightview VCT Imaging System Class I	Philips Medical Systems (Cleveland), Inc.	2008	1
K121019	Optima NM/CT 640 Class I	GE Healthcare	2012	0

Has anything in its family been recalled? (9 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Oct 14, 2014	Class II	Z-0185-2015	Nonconforming Material/Component	GE is issuing this recall due to a potential safety issue related to a portion of the system falling onto the patient during a scan due to fasteners being loose that secured the camera to the gantry. GE is updating the Preventative…
Oct 14, 2014	Class II	Z-0186-2015	Nonconforming Material/Component	GE is issuing this recall due to a potential safety issue related to a portion of the system falling onto the patient during a scan due to fasteners being loose that secured the camera to the gantry. GE is updating the Preventative…
Oct 14, 2014	Class II	Z-0188-2015	Nonconforming Material/Component	GE is issuing this recall due to a potential safety issue related to a portion of the system falling onto the patient during a scan due to fasteners being loose that secured the camera to the gantry. GE is updating the Preventative…
Oct 14, 2014	Class II	Z-0189-2015	Nonconforming Material/Component	GE is issuing this recall due to a potential safety issue related to a portion of the system falling onto the patient during a scan due to fasteners being loose that secured the camera to the gantry. GE is updating the Preventative…
Oct 14, 2014	Class II	Z-0187-2015	Nonconforming Material/Component	GE is updating the Preventative Maintenance procedure and schedule, and added an additional Preventative Maintenance check for loose fasteners on the Nuclear Medicaine systems. This check is being added to prevent a portion of the system…
Oct 14, 2014	Class II	Z-0184-2015	Nonconforming Material/Component	GE is issuing this recall due to a potential safety issue related to a portion of the system falling onto the patient during a scan due to fasteners being loose that secured the camera to the gantry. GE is updating the Preventative…
Jun 13, 2013	Class I	Z-1787-2013	Device Design	GE became aware of an incident at a VA Medical Center facility in the US in which a patient died due to injuries sustained while being scanned on an Infinia Hawkeye 4 Nuclear Medicine System.
Mar 6, 2012	Class II	Z-1078-2013	Process control	Accelerated fatigue of the lateral axis motion subsystem of the Infinia Computed Emission Tomography System could result in mechanical failure causing the detector to slide; may impact patient and operators.

The 5 latest of 8 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
K080927Brightview VCT Imaging SystemPhilips Medical Systems (Cleveland), Inc. · 2008 · Cites it directly · ◆ in the 2008 descendants bar of FIG. 12 Class I recalls
K093514Discovery Model NM/CT 670Ge Medical Systems F.I. Haifa · 2009 · Cites it directly · ◆ in the 2009 descendants bar of FIG. 12 Class I recalls
K121019Optima NM/CT 640GE Healthcare · 2012 · Cites it directly · ◆ in the 2012 descendants bar of FIG. 12 Class I recalls
K153402Discovery NM/CT 670 CZTGE Healthcare · 2016 · 2 generations on · ◆ in the 2016 descendants bar of FIG. 11 Class I recall
K173816NM/CT 850, NM/CT 860GE Healthcare · 2018 · 2 generations on · ◆ in the 2018 descendants bar of FIG. 11 Class I recall
K111445Discovery NM 630GE Healthcare · 2011 · 2 generations on · ◆ in the 2011 descendants bar of FIG. 12 Class I recalls
K113350Brivo NM 615GE Healthcare · 2011 · 3 generations on · ◆ in the 2011 descendants bar of FIG. 12 Class I recalls

Nearest 5 of 8; all are on the web page.

What does this lineage say?

The line of descent spans 10 years and passes through 3 companies; a new generation was cleared every 2.7 years on median.
2 of the 3 ancestors have a recall of any class; 1 has a Class I recall.
Of its descendants, K093514 (Ge Medical Systems F.I. Haifa, 2009) has gone furthest, with 13 descendants of its own.
5 other devices also cite its predicate K991841.

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?

The Intended use of the device is to produce attenuation- corrected NM Images. The attenuation maps are also displayed with the NM images to facilitate the localization of the NM activity in the patient anatomy.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K052434 · printed Nov 6, 2026

Cite this page

510(k) Report. “K052434: Hawkeye 4 Option for Dual-Head Variable Angle Gamma Camera.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052434

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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