510(k) · Cleared
Recalled · Class II · 2012Symbia-E, Model 10275879
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 Oct 30, 2007 as substantially equivalent to K963983 (Siemens Corp., 1997) and 4 other predicates after a 48-day review. Its family tree reaches back 5 generations to 1995. 7 of the 104 devices in its family, counting itself, have a Class I recall. 85 later devices descend from it. It has been recalled 2 times.
- Decided
- Oct 30, 2007
- Review
- 48 days
- Class
- Class II
- Product code
- KPS
- Recalls
- 2
- Predicates
- 5
Its longest line of descent runs back 5 generations to K952674 (1995). 18 ancestors in all, the oldest K892358 (1989). 85 later devices descend from it, 2 citing it directly. 7 of the 104 devices in this family, counting this one, have a Class I recall.
- Root · 5 generations backK952674 Transact: Attenuation Correction System for the Apex Cardial Gamma…Elscint, Inc. · 1995 · Recalled
- 4 generations backK980959 Vtransact: Attenuation Correction System for Dual-Head Variable…Ge Medical Systems F.I. Haifa · 1998
- 3 generations backK991841 Hawkeye Option for Dual-Head Variable Angle Gamma CameraGe Medical Systems F.I. Haifa · 1999 · Recalled (Class I)
- 2 generations backK023190 E.Cam Computer / E.Soft WorkstationSiemens Medical Solutions USA, Inc. · 2002
- 1 generation backK063826 Syngo MI Applications 2007ASiemens Medical Solutions USA, Inc. · 2007
- This deviceK072567 Symbia-E, Model 10275879Siemens Medical Solutions USA, Inc. · 2007
- Descendant · cites it directly · 83 of its ownK082506 Symbia, Version 4.0Siemens Medical Solutions USA, Inc. · 2008 · Recalled
- Descendant · 2 generations on · 66 of its ownK131634 SymbiaSiemens Medical Solutions USA, Inc. · 2013 · Recalled
- Descendant · 3 generations on · 65 of its ownK142006 Symbia 6.0Siemens Medical Solutions USA, Inc. · 2014 · Recalled
- Descendant · 4 generations on · 63 of its ownK162483 Symbia Intevo BoldSiemens Medical Solutions USA, Inc. · 2017
- Descendant · 5 generations on · 54 of its ownK180815 MIM - SPECTRA QuantMim Software, Inc. · 2018
Showing 5 of 85 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 85 · See all- K082506Symbia, Version 4.0Siemens Medical Solutions USA, Inc. · 2008 · cites it directly83descendants
- K131634SymbiaSiemens Medical Solutions USA, Inc. · 2013 · 2 generations on66descendants
- K142006Symbia 6.0Siemens Medical Solutions USA, Inc. · 2014 · 3 generations on65descendants
- K162483Symbia Intevo BoldSiemens Medical Solutions USA, Inc. · 2017 · 4 generations on63descendants
- K180815MIM - SPECTRA QuantMim Software, Inc. · 2018 · 5 generations on54descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K952674 | Transact: Attenuation Correction System for the Apex Cardial Gamma Camera | Elscint, Inc. | 1995 | 1 |
| −4 | K980959 | Vtransact: Attenuation Correction System for Dual-Head Variable Angle Gamma… | Ge Medical Systems F.I. Haifa | 1998 | — |
| −3 | K991841 | Hawkeye Option for Dual-Head Variable Angle Gamma Camera | Ge Medical Systems F.I. Haifa | 1999 | Class I |
| −2 | K023190 | E.Cam Computer / E.Soft Workstation | Siemens Medical Solutions USA, Inc. | 2002 | — |
| −1 | K063826 | Syngo MI Applications 2007A | Siemens Medical Solutions USA, Inc. | 2007 | — |
| 0 (this device) | K072567 | Symbia-E, Model 10275879 | Siemens Medical Solutions USA, Inc. | 2007 | — |
| +1 | K082506 | Symbia, Version 4.0 | Siemens Medical Solutions USA, Inc. | 2008 | 9 |
| +2 | K131634 | Symbia | Siemens Medical Solutions USA, Inc. | 2013 | 7 |
| +3 | K142006 | Symbia 6.0 | Siemens Medical Solutions USA, Inc. | 2014 | 9 |
| +4 | K162483 | Symbia Intevo Bold | Siemens Medical Solutions USA, Inc. | 2017 | — |
| +5 | K180815 | MIM - SPECTRA Quant | Mim Software, Inc. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1991 | 1 | 0 |
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 1 | 1 |
| 2010 | 1 | 0 |
| 2011 | 3 | 2 |
| 2012 | 1 | 1 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2016 | 2 | 1 |
| 2017 | 1 | 0 |
| 2018 | 4 | 1 |
| 2019 | 3 | 0 |
| 2020 | 4 | 0 |
| 2021 | 10 | 0 |
| 2022 | 7 | 0 |
| 2023 | 10 | 0 |
| 2024 | 10 | 0 |
| 2025 | 13 | 0 |
| 2026 | 11 | 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.
7 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? (5)
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 |
|---|---|---|---|
| * | K963983 | E. Cam Profile Attenuation CorrectionSummary page 1…ted Devices to which Equivalence is claimed Device Manufacturer 510(k) Number e.cam Siemens Medical K963983 Solutions USA, Inc Siemens Enhanced Siemens Medical K041166 Imaging Syst… | 1997 |
| * | K041166 | Siemens Enhanced Imaging SystemSummary page 1…am Siemens Medical K963983 Solutions USA, Inc Siemens Enhanced Siemens Medical K041166 Imaging System Solutions USA, Inc Syngo MI Applications Siemens Medical K063826 2007A… | 2004 |
| * | K063826 | Syngo MI Applications 2007ASummary page 1…mens Enhanced Siemens Medical K041166 Imaging System Solutions USA, Inc Syngo MI Applications Siemens Medical K063826 2007A Solutions USA, Inc c.carn Danish Diagnostic K031825… | 2007 |
| * | K031825 | C.CAMSummary page 1…go MI Applications Siemens Medical K063826 2007A Solutions USA, Inc c.carn Danish Diagnostic K031825 Development c.cam-AC Danish Diagnostic K051460… | 2003 |
| * | K051460 | C.Cam-ACSummary page 1…Inc c.carn Danish Diagnostic K031825 Development c.cam-AC Danish Diagnostic K051460 Development Template D0006237 Rev A P… | 2005 |
What descends from it? (85)
See all 852 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (7 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 15, 2012 | Not classified | Z-1686-2012 | Employee error | Siemens has identified a potential patient safety issue for e.cam and Symbia E camera systems that have had the radial drive motor assembly replaced during a Service action. There is a remote chance that during the motor replacement the… |
| Apr 11, 2012 | Class II | Z-1296-2015 | Employee error | Radial motor drives replaced during a customer service action were incorrectly assembled backwards. |
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 back · ◆ on the line of descent in 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?
- The line of descent spans 12 years and passes through 3 companies; a new generation was cleared every 2.7 years on median.
- 11 of the 18 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K082506 (Siemens Medical Solutions USA, Inc., 2008) has gone furthest, with 83 descendants of its own.
- 4 other devices also cite its predicate K963983.
How does its category compare?
All KPS devicesKPS System, Tomography, Computed, Emission: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
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 for isotopes with energies up to 588keV.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072567 · printed Nov 4, 2026
Cite this page
510(k) Report. “K072567: Symbia-E, Model 10275879.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K072567
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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