510(k) · Cleared
Recalled · Class I · 2014Hawkeye Option for Dual-Head Variable Angle Gamma Camera
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 Aug 26, 1999 as substantially equivalent to K980959 (Ge Medical Systems F.I. Haifa, 1998) after a 90-day review. Its family tree reaches back 2 generations to 1995. 10 of the 123 devices in its family, counting itself, have a Class I recall. 120 later devices descend from it. It has been recalled 8 times, including a Class I recall.
- Decided
- Aug 26, 1999
- Review
- 90 days
- Class
- Class II
- Product code
- KPS
- Recalls
- 8 (1 Class I)
- Predicates
- 2
Its longest line of descent runs back 2 generations to K952674 (1995). 120 later devices descend from it, 6 citing it directly. 10 of the 123 devices in this family, counting this one, have a Class I recall.
- Root · 2 generations backK952674 Transact: Attenuation Correction System for the Apex Cardial Gamma…Elscint, Inc. · 1995 · Recalled
- 1 generation backK980959 Vtransact: Attenuation Correction System for Dual-Head Variable…Ge Medical Systems F.I. Haifa · 1998
- This deviceK991841 Hawkeye Option for Dual-Head Variable Angle Gamma CameraGe Medical Systems F.I. Haifa · 1999
- Descendant · cites it directly · 104 of its ownK023190 E.Cam Computer / E.Soft WorkstationSiemens Medical Solutions USA, Inc. · 2002
- Descendant · cites it directly · 87 of its ownK041166 Siemens Enhanced Imaging SystemSiemens Medical Solutions USA, Inc. · 2004 · Recalled
- Descendant · 2 generations on · 86 of its ownK063826 Syngo MI Applications 2007ASiemens Medical Solutions USA, Inc. · 2007
- Descendant · 2 generations on · 85 of its ownK072567 Symbia-E, Model 10275879Siemens Medical Solutions USA, Inc. · 2007 · Recalled
- Descendant · 2 generations on · 83 of its ownK082506 Symbia, Version 4.0Siemens Medical Solutions USA, Inc. · 2008 · Recalled
Showing 5 of 120 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 120 · See all- K023190E.Cam Computer / E.Soft WorkstationSiemens Medical Solutions USA, Inc. · 2002 · cites it directly104descendants
- K041166Siemens Enhanced Imaging SystemSiemens Medical Solutions USA, Inc. · 2004 · cites it directly87descendants
- K063826Syngo MI Applications 2007ASiemens Medical Solutions USA, Inc. · 2007 · 2 generations on86descendants
- K072567Symbia-E, Model 10275879Siemens Medical Solutions USA, Inc. · 2007 · 2 generations on85descendants
- K082506Symbia, Version 4.0Siemens Medical Solutions USA, Inc. · 2008 · 2 generations on83descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K952674 | Transact: Attenuation Correction System for the Apex Cardial Gamma Camera | Elscint, Inc. | 1995 | 1 |
| −1 | K980959 | Vtransact: Attenuation Correction System for Dual-Head Variable Angle Gamma… | Ge Medical Systems F.I. Haifa | 1998 | — |
| 0 (this device) | K991841 | Hawkeye Option for Dual-Head Variable Angle Gamma Camera | Ge Medical Systems F.I. Haifa | 1999 | — |
| +1 | K023190 | E.Cam Computer / E.Soft Workstation | Siemens Medical Solutions USA, Inc. | 2002 | — |
| +1 | K041166 | Siemens Enhanced Imaging System | Siemens Medical Solutions USA, Inc. | 2004 | 12 |
| +2 | K063826 | Syngo MI Applications 2007A | Siemens Medical Solutions USA, Inc. | 2007 | — |
| +2 | K072567 | Symbia-E, Model 10275879 | Siemens Medical Solutions USA, Inc. | 2007 | 2 |
| +2 | K082506 | Symbia, Version 4.0 | Siemens Medical Solutions USA, Inc. | 2008 | 9 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
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 18.6 · 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? (2)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K980959 | Vtransact: Attenuation Correction System for Dual-Head Variable Angle Gamma CameraSummary page 1…son for 510(k) Submission Modification of legally marketed device. Identification of Legally Marketed Equivalent Devices VTransACT option for the VariCam Gamma Camera - K980959 Advanced Analysis Software: Fusion/Registration and rCBF Autoradiographic Model - K941223/S1 Device Description The Hawkeye Opti… | 1998 |
| Kept off the family tree | K941223/ | Advanced Analysis Software: Fusion/Registration and rCBF Autoradiographic Model Number could not be read Summary page 1…lly Marketed Equivalent Devices VTransACT option for the VariCam Gamma Camera - K980959 Advanced Analysis Software: Fusion/Registration and rCBF Autoradiographic Model - K941223/S1 Device Description The Hawkeye Option is an addition to the Apex VariCam / Millennium VG gamma cameras (K953801). It comprises a… |
What descends from it? (120)
See all 1206 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K023190 | E.Cam Computer / E.Soft Workstation | 2002 | 104 |
| K041166 | Siemens Enhanced Imaging System | 2004 | 87 |
| K022960 | GE Quasar Nuclear Medicine System Class I | 2002 | 23 |
| K052434 | Hawkeye 4 Option for Dual-Head Variable Angle Gamma Camera Class I | 2005 | 16 |
| K043381 | Infinia Lightspeed | 2004 | 1 |
| K071195 | KHBS (Krishnamurthy Hepato-Biliary Software), Model Version 1.5 | 2007 | 0 |
Has anything in its family been recalled? (10 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.
- K022960GE Quasar Nuclear Medicine SystemGe Medical Systems F.I. Haifa · 2002 · Cites it directly · ◆ in the 2002 descendants bar of FIG. 11 Class I recall
- K052434Hawkeye 4 Option for Dual-Head Variable Angle Gamma CameraGE Medical Systems · 2005 · Cites it directly · ◆ in the 2005 descendants bar of 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
- K080927Brightview VCT Imaging SystemPhilips Medical Systems (Cleveland), Inc. · 2008 · 2 generations on · ◆ in the 2008 descendants bar of FIG. 12 Class I recalls
- K121019Optima NM/CT 640GE Healthcare · 2012 · 2 generations on · ◆ in the 2012 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
Nearest 5 of 9; all are on the web page.
What does this lineage say?
- The line of descent spans 4 years and passes through 2 companies; a new generation was cleared every 2.7 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K023190 (Siemens Medical Solutions USA, Inc., 2002) has gone furthest, with 104 descendants of its own.
- 2 other devices also cite its predicate K980959.
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?
To obtain attenuation corrected emission images and to provide
registration of anatomical and physiological 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/K991841 · printed Nov 6, 2026
Cite this page
510(k) Report. “K991841: Hawkeye 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/K991841
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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