510(k) · Cleared
Recalled · Class II · 2025Transact: Attenuation Correction System for the Apex Cardial Gamma Camera
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Elscint, Inc. · KPS System, Tomography, Computed, Emission
Cleared on Sep 26, 1995 after a 106-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 10 of the 126 devices in its family, counting itself, have a Class I recall. 125 later devices descend from it. It has been recalled once.
- Decided
- Sep 26, 1995
- Review
- 106 days
- Class
- Class II
- Product code
- KPS
- Recalls
- 1
- Predicates
- 0
125 later devices descend from it, 2 citing it directly. 10 of the 126 devices in this family, counting this one, have a Class I recall.
- This deviceK952674 Transact: Attenuation Correction System for the Apex Cardial Gamma…Elscint, Inc. · 1995
- Descendant · cites it directly · 123 of its ownK980959 Vtransact: Attenuation Correction System for Dual-Head Variable…Ge Medical Systems F.I. Haifa · 1998
- Descendant · 2 generations on · 120 of its ownK991841 Hawkeye Option for Dual-Head Variable Angle Gamma CameraGe Medical Systems F.I. Haifa · 1999 · Recalled (Class I)
- Descendant · 3 generations on · 104 of its ownK023190 E.Cam Computer / E.Soft WorkstationSiemens Medical Solutions USA, Inc. · 2002
- Descendant · 3 generations on · 87 of its ownK041166 Siemens Enhanced Imaging SystemSiemens Medical Solutions USA, Inc. · 2004 · Recalled
- Descendant · 4 generations on · 86 of its ownK063826 Syngo MI Applications 2007ASiemens Medical Solutions USA, Inc. · 2007
Showing 5 of 125 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 125 · See all- K980959Vtransact: Attenuation Correction System for Dual-Head Variable Angle Gamma CameraGe Medical Systems F.I. Haifa · 1998 · cites it directly123descendants
- K991841Hawkeye Option for Dual-Head Variable Angle Gamma CameraGe Medical Systems F.I. Haifa · 1999 · 2 generations on120descendants
- K023190E.Cam Computer / E.Soft WorkstationSiemens Medical Solutions USA, Inc. · 2002 · 3 generations on104descendants
- K041166Siemens Enhanced Imaging SystemSiemens Medical Solutions USA, Inc. · 2004 · 3 generations on87descendants
- K063826Syngo MI Applications 2007ASiemens Medical Solutions USA, Inc. · 2007 · 4 generations on86descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K952674 | Transact: Attenuation Correction System for the Apex Cardial Gamma Camera | Elscint, Inc. | 1995 | — |
| +1 | 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 |
| +3 | K023190 | E.Cam Computer / E.Soft Workstation | Siemens Medical Solutions USA, Inc. | 2002 | — |
| +3 | K041166 | Siemens Enhanced Imaging System | Siemens Medical Solutions USA, Inc. | 2004 | 12 |
| +4 | K063826 | Syngo MI Applications 2007A | Siemens Medical Solutions USA, Inc. | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 2 | 0 |
| 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 |
Sources: FDA 510(k) database (decision fields), 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
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (125)
See all 1252 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (10 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 12, 2025 | Class II | Z-0290-2026 | Package design/selection | GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service could have been transported or relocated without adequate detector support. This could result in excessive stress being… |
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 on · ◆ in the 1999 descendants bar of FIG. 11 Class I recall
- K022960GE Quasar Nuclear Medicine SystemGe Medical Systems F.I. Haifa · 2002 · 3 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 · 3 generations on · ◆ in the 2005 descendants bar of FIG. 11 Class I recall
- K093514Discovery Model NM/CT 670Ge Medical Systems F.I. Haifa · 2009 · 4 generations on · ◆ in the 2009 descendants bar of FIG. 12 Class I recalls
- K080927Brightview VCT Imaging SystemPhilips Medical Systems (Cleveland), Inc. · 2008 · 4 generations on · ◆ in the 2008 descendants bar of FIG. 12 Class I recalls
- K121019Optima NM/CT 640GE Healthcare · 2012 · 4 generations on · ◆ in the 2012 descendants bar of FIG. 12 Class I recalls
- K153402Discovery NM/CT 670 CZTGE Healthcare · 2016 · 5 generations on · ◆ in the 2016 descendants bar of FIG. 11 Class I recall
- K173816NM/CT 850, NM/CT 860GE Healthcare · 2018 · 5 generations on · ◆ in the 2018 descendants bar of FIG. 11 Class I recall
- K111445Discovery NM 630GE Healthcare · 2011 · 5 generations on · ◆ in the 2011 descendants bar of FIG. 12 Class I recalls
- K113350Brivo NM 615GE Healthcare · 2011 · 6 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?
- Of its descendants, K980959 (Ge Medical Systems F.I. Haifa, 1998) has gone furthest, with 123 descendants of its own.
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 | — |
https://510kreport.com/device/K952674 · printed Nov 4, 2026
Cite this page
510(k) Report. “K952674: Transact: Attenuation Correction System for the Apex Cardial 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/K952674
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026