510(k) · Cleared
Recalled · Class I · 2025Varicam
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 Nov 22, 1995 after a 103-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 8 of the 26 devices in its family, counting itself, have a Class I recall. 25 later devices descend from it. It has been recalled 7 times, including a Class I recall.
- Decided
- Nov 22, 1995
- Review
- 103 days
- Class
- Class II
- Product code
- KPS
- Recalls
- 7 (1 Class I)
- Predicates
- 0
25 later devices descend from it, 2 citing it directly. 8 of the 26 devices in this family, counting this one, have a Class I recall.
- This deviceK953801 VaricamElscint, Inc. · 1995
- Descendant · cites it directly · 23 of its ownK022960 GE Quasar Nuclear Medicine SystemGe Medical Systems F.I. Haifa · 2002 · Recalled (Class I)
- Descendant · 2 generations on · 13 of its ownK093514 Discovery Model NM/CT 670Ge Medical Systems F.I. Haifa · 2009 · Recalled (Class I)
- Descendant · 3 generations on · 6 of its ownK153402 Discovery NM/CT 670 CZTGE Healthcare · 2016 · Recalled (Class I)
- Descendant · 4 generations on · 3 of its ownK182484 VERITON CT whole body SPECT/CT systemSpectrum Dynamics Medical, Ltd. · 2018
- Descendant · 2 generations on · 3 of its ownK102231 Discovery NM 750BGe Medical Systems Israel, Functional Imaging · 2010
Showing 5 of 25 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 25 · See all- K022960GE Quasar Nuclear Medicine SystemGe Medical Systems F.I. Haifa · 2002 · cites it directly23descendants
- K093514Discovery Model NM/CT 670Ge Medical Systems F.I. Haifa · 2009 · 2 generations on13descendants
- K153402Discovery NM/CT 670 CZTGE Healthcare · 2016 · 3 generations on6descendants
- K182484VERITON CT whole body SPECT/CT systemSpectrum Dynamics Medical, Ltd. · 2018 · 4 generations on3descendants
- K102231Discovery NM 750BGe Medical Systems Israel, Functional Imaging · 2010 · 2 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K953801 | Varicam | Elscint, Inc. | 1995 | — |
| +1 | K022960 | GE Quasar Nuclear Medicine System | Ge Medical Systems F.I. Haifa | 2002 | Class I |
| +2 | K093514 | Discovery Model NM/CT 670 | Ge Medical Systems F.I. Haifa | 2009 | Class I |
| +3 | K153402 | Discovery NM/CT 670 CZT | GE Healthcare | 2016 | Class I |
| +4 | K182484 | VERITON CT whole body SPECT/CT system | Spectrum Dynamics Medical, Ltd. | 2018 | — |
| +2 | K102231 | Discovery NM 750B | Ge Medical Systems Israel, Functional Imaging | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 2002 | 1 | 1 |
| 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), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
8 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? (25)
See all 252 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (8 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 20, 2025 | Class II | Z-2098-2025 | 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-0900-2025 | 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 30, 2017 | Class II | Z-0704-2019 | Other | A potential hazardous situation may occur if the collimator locking handle is not properly placed in the lock position and the warning circuit does not detect that the collimator is unlocked because of the patient proximity to the… |
| Oct 30, 2017 | Class II | Z-0703-2019 | Other | A potential hazardous situation may occur if the collimator locking handle is not properly placed in the lock position and the warning circuit does not detect that the collimator is unlocked because of the patient proximity to the… |
| Mar 5, 2015 | Class II | Z-1279-2015 | Use error | GE Healthcare has recently become aware of a potential safety issue due to a collimator falling off a VG system during a Quality Control check, while the detectors were rotating. No injuries have been reported to date |
| Jun 13, 2013 | Class I | Z-1788-2013 | 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. |
| Sep 3, 2004 | Not classified | Z-0012-05 | Other | GE Healthcare received reports of intermittent low ejection fraction (EF) results for MUGA (multi-gated acquisitions) studies on Millennium VG systems. This issue can occasionally lead to distortions in the volume curve in some MUGA… |
The 5 latest of 7 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
- 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
- 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
- K121019Optima NM/CT 640GE Healthcare · 2012 · 4 generations on · ◆ in the 2012 descendants bar of FIG. 12 Class I recalls
Nearest 5 of 7; all are on the web page.
What does this lineage say?
- Of its descendants, K022960 (Ge Medical Systems F.I. Haifa, 2002) has gone furthest, with 23 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/K953801 · printed Nov 4, 2026
Cite this page
510(k) Report. “K953801: Varicam.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K953801
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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