510(k) · Cleared
ClearedPegasys Nuclear Medicine Imaging Computer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Adac Laboratories · KPS System, Tomography, Computed, Emission
Cleared on Aug 23, 1989 after a 139-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 6 of the 138 devices in its family, counting itself, have a Class I recall. 137 later devices descend from it.
- Decided
- Aug 23, 1989
- Review
- 139 days
- Class
- Class II
- Product code
- KPS
- Recalls
- None
- Predicates
- 0
137 later devices descend from it, 4 citing it directly. 6 of the 138 devices in this family, counting this one, have a Class I recall.
- This deviceK892358 Pegasys Nuclear Medicine Imaging ComputerAdac Laboratories · 1989
- Descendant · cites it directly · 111 of its ownK992731 E.Cam ComputerSiemens Medical Solutions USA, Inc. · 1999 · Recalled
- Descendant · cites it directly · 104 of its ownK023190 E.Cam Computer / E.Soft WorkstationSiemens Medical Solutions USA, Inc. · 2002
- Descendant · 2 generations on · 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 · 3 generations on · 85 of its ownK072567 Symbia-E, Model 10275879Siemens Medical Solutions USA, Inc. · 2007 · Recalled
Showing 5 of 137 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 137 · See all- K992731E.Cam ComputerSiemens Medical Solutions USA, Inc. · 1999 · cites it directly111descendants
- K023190E.Cam Computer / E.Soft WorkstationSiemens Medical Solutions USA, Inc. · 2002 · cites it directly104descendants
- K041166Siemens Enhanced Imaging SystemSiemens Medical Solutions USA, Inc. · 2004 · 2 generations on87descendants
- K063826Syngo MI Applications 2007ASiemens Medical Solutions USA, Inc. · 2007 · 2 generations on86descendants
- K072567Symbia-E, Model 10275879Siemens Medical Solutions USA, Inc. · 2007 · 3 generations on85descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K892358 | Pegasys Nuclear Medicine Imaging Computer | Adac Laboratories | 1989 | — |
| +1 | K992731 | E.Cam Computer | Siemens Medical Solutions USA, Inc. | 1999 | 1 |
| +1 | K023190 | E.Cam Computer / E.Soft Workstation | Siemens Medical Solutions USA, Inc. | 2002 | — |
| +2 | K041166 | Siemens Enhanced Imaging System | Siemens Medical Solutions USA, Inc. | 2004 | 12 |
| +2 | K063826 | Syngo MI Applications 2007A | Siemens Medical Solutions USA, Inc. | 2007 | — |
| +3 | K072567 | Symbia-E, Model 10275879 | Siemens Medical Solutions USA, Inc. | 2007 | 2 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 4 | 0 |
| 2004 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 4 | 0 |
| 2008 | 2 | 0 |
| 2009 | 2 | 1 |
| 2010 | 5 | 0 |
| 2011 | 7 | 2 |
| 2012 | 2 | 1 |
| 2013 | 3 | 0 |
| 2014 | 2 | 0 |
| 2015 | 2 | 0 |
| 2016 | 6 | 1 |
| 2017 | 2 | 0 |
| 2018 | 8 | 1 |
| 2019 | 3 | 0 |
| 2020 | 7 | 0 |
| 2021 | 13 | 0 |
| 2022 | 7 | 0 |
| 2023 | 12 | 0 |
| 2024 | 11 | 0 |
| 2025 | 17 | 0 |
| 2026 | 13 | 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.
6 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (137)
See all 1374 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (6 Class I)
No FDA recall names this device.
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.
- 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
- 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
- K121019Optima NM/CT 640GE Healthcare · 2012 · 6 generations on · ◆ in the 2012 descendants bar of FIG. 12 Class I recalls
Nearest 5 of 6; all are on the web page.
What does this lineage say?
- Of its descendants, K992731 (Siemens Medical Solutions USA, Inc., 1999) has gone furthest, with 111 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/K892358 · printed Nov 4, 2026
Cite this page
510(k) Report. “K892358: Pegasys Nuclear Medicine Imaging Computer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K892358
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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