510(k) · Cleared
Recalled · Class II · 2014E.Cam Computer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Medical Solutions USA, Inc. · KPS System, Tomography, Computed, Emission
Cleared on Nov 10, 1999 as substantially equivalent to K952109 (Siemens Medical Solutions USA, Inc., 1995) and 2 other predicates after an 89-day review. Its family tree reaches back 1 generation to 1989. 6 of the 115 devices in its family, counting itself, have a Class I recall. 111 later devices descend from it. It has been recalled once.
- Decided
- Nov 10, 1999
- Review
- 89 days
- Class
- Class II
- Product code
- KPS
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 1 generation to K892358 (1989). 3 ancestors in all. 111 later devices descend from it, 5 citing it directly. 6 of the 115 devices in this family, counting this one, have a Class I recall.
- Root · 1 generation backK892358 Pegasys Nuclear Medicine Imaging ComputerAdac Laboratories · 1989
- This deviceK992731 E.Cam ComputerSiemens Medical Solutions USA, Inc. · 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 · cites it directly · 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 111 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 111 · 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 · cites it directly86descendants
- 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 |
|---|---|---|---|---|---|
| −1 | K892358 | Pegasys Nuclear Medicine Imaging Computer | Adac Laboratories | 1989 | — |
| 0 (this device) | K992731 | E.Cam Computer | Siemens Medical Solutions USA, Inc. | 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 |
| +1 | 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 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 3 | 0 |
| 2004 | 1 | 0 |
| 2007 | 3 | 0 |
| 2008 | 1 | 0 |
| 2009 | 2 | 1 |
| 2010 | 5 | 0 |
| 2011 | 3 | 2 |
| 2012 | 2 | 1 |
| 2013 | 3 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 3 | 1 |
| 2017 | 2 | 0 |
| 2018 | 6 | 1 |
| 2019 | 3 | 0 |
| 2020 | 6 | 0 |
| 2021 | 11 | 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.
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? (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 |
|---|---|---|---|
| * | K952109 | IP500 Nuclear Gamma Camera SystemSummary page 1…ter, Emission Tomography System (Computer) is substantially equivalent to the currently marketed by Siemens Medical Systems, Inc., Nuclear Medicine Group, E.CAM (IP-500, K952109) and ICON (K903315B) and ADAC Pegasys (K892358). Contact: Robert W. Callahan Manager of Regulatory Affairs Siemens Medical Sys… | 1995 |
| * | K903315 | ICONSummary page 1…raphy System (Computer) is substantially equivalent to the currently marketed by Siemens Medical Systems, Inc., Nuclear Medicine Group, E.CAM (IP-500, K952109) and ICON (K903315B) and ADAC Pegasys (K892358). Contact: Robert W. Callahan Manager of Regulatory Affairs Siemens Medical Systems, Inc. Nuclear… | 1991 |
| * | K892358 | Pegasys Nuclear Medicine Imaging ComputerSummary page 1…ubstantially equivalent to the currently marketed by Siemens Medical Systems, Inc., Nuclear Medicine Group, E.CAM (IP-500, K952109) and ICON (K903315B) and ADAC Pegasys (K892358). Contact: Robert W. Callahan Manager of Regulatory Affairs Siemens Medical Systems, Inc. Nuclear Medicine Group 2501 North B… | 1989 |
What descends from it? (111)
See all 1115 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 8, 2014 | Class II | Z-0914-2015 | Use error | There is a potential for patient finger injury on the e.cam systems. |
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 · 3 generations on · ◆ in the 2009 descendants bar of FIG. 12 Class I recalls
- K153402Discovery NM/CT 670 CZTGE Healthcare · 2016 · 4 generations on · ◆ in the 2016 descendants bar of FIG. 11 Class I recall
- K173816NM/CT 850, NM/CT 860GE Healthcare · 2018 · 4 generations on · ◆ in the 2018 descendants bar of FIG. 11 Class I recall
- K111445Discovery NM 630GE Healthcare · 2011 · 4 generations on · ◆ in the 2011 descendants bar of FIG. 12 Class I recalls
- K113350Brivo NM 615GE Healthcare · 2011 · 5 generations on · ◆ in the 2011 descendants bar of FIG. 12 Class I recalls
- K121019Optima NM/CT 640GE Healthcare · 2012 · 5 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?
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 detect or image the distribution of radionuclides in the body or organ, using the following techniques:
Planar Imaging
Whole body imaging
Tomographic imaging (SPECT) for non positron emitter
Positron imaging by coincidence
Positron imaging without coincidence up to 588 keV
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/K992731 · printed Nov 6, 2026
Cite this page
510(k) Report. “K992731: E.Cam Computer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K992731
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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