510(k) · Cleared
Recalled · Class I · 2025GE Quasar Nuclear Medicine System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ge Medical Systems F.I. Haifa · KPS System, Tomography, Computed, Emission
Cleared on Sep 19, 2002 as substantially equivalent to K953801 (Elscint, Inc., 1995) and 2 other predicates after a 13-day review. Its family tree reaches back 3 generations to 1995. 9 of the 29 devices in its family, counting itself, have a Class I recall. 23 later devices descend from it. It has been recalled 24 times, including a Class I recall.
- Decided
- Sep 19, 2002
- Review
- 13 days
- Class
- Class II
- Product code
- KPS
- Recalls
- 24 (1 Class I)
- Predicates
- 3
Its longest line of descent runs back 3 generations to K952674 (1995). 5 ancestors in all. 23 later devices descend from it, 4 citing it directly. 9 of the 29 devices in this family, counting this one, have a Class I recall.
- 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 deviceK022960 GE Quasar Nuclear Medicine SystemGe Medical Systems F.I. Haifa · 2002
- 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 · cites it directly · 3 of its ownK102231 Discovery NM 750BGe Medical Systems Israel, Functional Imaging · 2010
- Descendant · cites it directly · 3 of its ownK051855 VentriGe Medical Systems F.I. Haifa · 2005 · Recalled
Showing 5 of 23 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 23 · 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
- K102231Discovery NM 750BGe Medical Systems Israel, Functional Imaging · 2010 · cites it directly3descendants
- K051855VentriGe Medical Systems F.I. Haifa · 2005 · cites it directly3descendants
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) | K022960 | GE Quasar Nuclear Medicine System | Ge Medical Systems F.I. Haifa | 2002 | — |
| +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 | — |
| +1 | K102231 | Discovery NM 750B | Ge Medical Systems Israel, Functional Imaging | 2010 | — |
| +1 | K051855 | Ventri | Ge Medical Systems F.I. Haifa | 2005 | 3 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 1 |
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 1 |
| 2010 | 1 | 0 |
| 2011 | 3 | 2 |
| 2012 | 1 | 1 |
| 2013 | 1 | 0 |
| 2016 | 2 | 1 |
| 2018 | 2 | 1 |
| 2019 | 1 | 0 |
| 2021 | 2 | 0 |
| 2023 | 1 | 0 |
| 2025 | 3 | 0 |
| 2026 | 1 | 0 |
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
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 | Decided |
|---|---|---|---|
| * | K953801 | VaricamSummary page 1…Reason for 510(k) Submission Modification of legally marketed device. Identification of Legallv Marketed Equivalent Devices Elscint Apex VariCam - K953801 GE Hawkeye Option for Dual-Head Variable Angle Gamma Camera - K991841 GE CoDe Option; Volumetric Coinci… | 1995 |
| * | K991841 | Hawkeye Option for Dual-Head Variable Angle Gamma CameraSummary page 1…ntification of Legallv Marketed Equivalent Devices Elscint Apex VariCam - K953801 GE Hawkeye Option for Dual-Head Variable Angle Gamma Camera - K991841 GE CoDe Option; Volumetric Coincidence Detection (CoDe) Imaging System for VariCam (Nuclear Medicine System)… | 1999 |
| * | K962100 | Volmetric Coincidence Detection SystemSummary page 1…e Gamma Camera - K991841 GE CoDe Option; Volumetric Coincidence Detection (CoDe) Imaging System for VariCam (Nuclear Medicine System) - K962 100 24of51 DEPARTMENT OF HEALTH… | 1997 |
What descends from it? (23)
See all 234 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (9 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 20, 2025 | Class II | Z-2097-2025 | Software design | Unintended radial detector motion may occur during patient setup or during patient scan if system does not have correct version of gantry software installed. Unintended detector motion may result in life-threatening injury. |
| Dec 18, 2024 | Class II | Z-0888-2025 | Package design/selection | GE HealthCare has become aware that certain Infinia, VariCam/VG/VH, Brivo NM 615, Discovery NM 630, Discovery NM/CT 670, and Optima NM/CT 640 Nuclear Medicine systems (see Affected Products Details and Appendices) could have been… |
| Dec 18, 2024 | Class II | Z-0897-2025 | Package design/selection | GE HealthCare has become aware that certain Infinia, VariCam/VG/VH, Brivo NM 615, Discovery NM 630, Discovery NM/CT 670, and Optima NM/CT 640 Nuclear Medicine systems (see Affected Products Details and Appendices) could have been… |
| Dec 18, 2024 | Class II | Z-0898-2025 | Package design/selection | GE HealthCare has become aware that certain Infinia, VariCam/VG/VH, Brivo NM 615, Discovery NM 630, Discovery NM/CT 670, and Optima NM/CT 640 Nuclear Medicine systems (see Affected Products Details and Appendices) could have been… |
| Dec 18, 2024 | Class II | Z-0899-2025 | Package design/selection | GE HealthCare has become aware that certain Infinia, VariCam/VG/VH, Brivo NM 615, Discovery NM 630, Discovery NM/CT 670, and Optima NM/CT 640 Nuclear Medicine systems (see Affected Products Details and Appendices) could have been… |
| 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… |
| Feb 7, 2014 | Class II | Z-1198-2014 | Device Design | Potential safety issue related to unintended radial detector motion, which may occur during patient setup or at the end of a patient scan. This failure mode has been observed on a single system, in which the detector moved to the home… |
| Feb 7, 2014 | Class II | Z-1200-2014 | Device Design | Potential safety issue related to unintended radial detector motion, which may occur during patient setup or at the end of a patient scan. This failure mode has been observed on a single system, in which the detector moved to the home… |
| Feb 7, 2014 | Class II | Z-1199-2014 | Device Design | Potential safety issue related to unintended radial detector motion, which may occur during patient setup or at the end of a patient scan. This failure mode has been observed on a single system, in which the detector moved to the home… |
| 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. |
| Sep 8, 2008 | Not classified | Z-1095-2009 | Software design | There is a possibility for misregistration when brain scans are performed with Infinia with the Hawkeye option. This misregistration could present the potential for misdiagnosis when the patient headrest sags under the weight of a head. |
| Sep 8, 2008 | Not classified | Z-1094-2009 | Software design | There is a possibility for misregistration when brain scans are performed with Infinia with the Hawkeye option. This misregistration could present the potential for misdiagnosis when the patient headrest sags under the weight of a head. |
| Jun 2, 2008 | Not classified | Z-1001-2009 | Device Design | GE Healthcare has recently became aware of excessive pressure applied by the collimator pressure sensitive cover of Infinia (Infinia, Infinia Hawkeye, Infinia Hawkeye 4) that may impact patient safety. It was reported at a customer site… |
| Jun 2, 2008 | Not classified | Z-1003-2009 | Device Design | GE Healthcare has recently became aware of excessive pressure applied by the collimator pressure sensitive cover of Infinia (Infinia, Infinia Hawkeye, Infinia Hawkeye 4) that may impact patient safety. It was reported at a customer site… |
| Jun 2, 2008 | Not classified | Z-1002-2009 | Device Design | GE Healthcare has recently became aware of excessive pressure applied by the collimator pressure sensitive cover of Infinia (Infinia, Infinia Hawkeye, Infinia Hawkeye 4) that may impact patient safety. It was reported at a customer site… |
| Jun 2, 2008 | Not classified | Z-1121-2009 | Other | The metal pin in the adjustable head holder, which is used to acquire Brain SPECT data on Infinia systems (Infinia, Infinia Hawkeye, and Infinia Hawkeye 4), creates an artifact on the patient's cerebellum, which may lead to the potential… |
| Jun 2, 2008 | Not classified | Z-1120-2009 | Other | The metal pin in the adjustable head holder, which is used to acquire Brain SPECT data on Infinia systems (Infinia, Infinia Hawkeye, and Infinia Hawkeye 4), creates an artifact on the patient's cerebellum, which may lead to the potential… |
| Jun 2, 2008 | Not classified | Z-1119-2009 | Other | The metal pin in the adjustable head holder, which is used to acquire Brain SPECT data on Infinia systems (Infinia, Infinia Hawkeye, and Infinia Hawkeye 4), creates an artifact on the patient's cerebellum, which may lead to the potential… |
The 5 latest of 24 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
- K953801VaricamElscint, Inc. · 1995 · Direct predicate · ◆ in the 1995 ancestors bar of FIG. 11 Class I recall
- 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
- 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
- K121019Optima NM/CT 640GE Healthcare · 2012 · 3 generations on · ◆ in the 2012 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 7 years and passes through 2 companies; a new generation was cleared every 2.7 years on median.
- 3 of the 5 ancestors have a recall of any class; 2 have a Class I recall.
- Of its descendants, K093514 (Ge Medical Systems F.I. Haifa, 2009) has gone furthest, with 13 descendants of its own.
- 1 other device also cites its predicate K953801.
How does its category compare?
All KPS devicesKPS System, Tomography, Computed, Emission: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KPS
12in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KPS
65in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KPS
16in 2025
Class I (17 since 2007) Class II/III not classified
Adverse event reports per year · KPS
36in 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 Quasar system is to perform general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scanning modes supported by various acquisition types and optional imaging features designed to enhance image quality in Oncology, Cardiology, Neurology and other clinical diagnostic imaging applications. The scanning modes include planar (Static, Multi-gated, Dynamic, Whole…
Read the full statement (121 words)
The intended use of the Quasar system is to perform general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scanning modes supported by various acquisition types and optional imaging features designed to enhance image quality in Oncology, Cardiology, Neurology and other clinical diagnostic imaging applications.
The scanning modes include planar (Static, Multi-gated, Dynamic, Whole body scanning) and tomographic (SPECT , Gated SPECT , Whole body SPECT , Camera based PET - also known as Coincidence Detection). Acquisition types include single and multi-isotope/multi-peak frame/list mode single-photon and positron imaging. Optional imaging-enhancement features include assortment of collimators, gating by physiological signals, real-time automatic body contouring, and CT-based attenuation correction and functional anatomic mapping.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K022960 · printed Nov 5, 2026
Cite this page
510(k) Report. “K022960: GE Quasar Nuclear Medicine System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K022960
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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