510(k) · Cleared
Recalled · Class II · 2014Symbia, Version 4.0
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 21, 2008 as substantially equivalent to K041166 (Siemens Medical Solutions USA, Inc., 2004) and 3 other predicates after an 84-day review. Its family tree reaches back 6 generations to 1995. 7 of the 103 devices in its family, counting itself, have a Class I recall. 83 later devices descend from it. It has been recalled 9 times.
- Decided
- Nov 21, 2008
- Review
- 84 days
- Class
- Class II
- Product code
- KPS
- Recalls
- 9
- Predicates
- 4
Its longest line of descent runs back 6 generations to K952674 (1995). 19 ancestors in all, the oldest K892358 (1989). 83 later devices descend from it, 4 citing it directly. 7 of the 103 devices in this family, counting this one, have a Class I recall.
- Root · 6 generations backK952674 Transact: Attenuation Correction System for the Apex Cardial Gamma…Elscint, Inc. · 1995 · Recalled
- 5 generations backK980959 Vtransact: Attenuation Correction System for Dual-Head Variable…Ge Medical Systems F.I. Haifa · 1998
- 4 generations backK991841 Hawkeye Option for Dual-Head Variable Angle Gamma CameraGe Medical Systems F.I. Haifa · 1999 · Recalled (Class I)
- 3 generations backK023190 E.Cam Computer / E.Soft WorkstationSiemens Medical Solutions USA, Inc. · 2002
- 2 generations backK063826 Syngo MI Applications 2007ASiemens Medical Solutions USA, Inc. · 2007
- 1 generation backK072567 Symbia-E, Model 10275879Siemens Medical Solutions USA, Inc. · 2007 · Recalled
- This deviceK082506 Symbia, Version 4.0Siemens Medical Solutions USA, Inc. · 2008
- Descendant · cites it directly · 66 of its ownK131634 SymbiaSiemens Medical Solutions USA, Inc. · 2013 · Recalled
- Descendant · 2 generations on · 65 of its ownK142006 Symbia 6.0Siemens Medical Solutions USA, Inc. · 2014 · Recalled
- Descendant · 3 generations on · 63 of its ownK162483 Symbia Intevo BoldSiemens Medical Solutions USA, Inc. · 2017
- Descendant · 4 generations on · 54 of its ownK180815 MIM - SPECTRA QuantMim Software, Inc. · 2018
- Descendant · 5 generations on · 53 of its ownK182624 MIM - MRT DosimetryMim Software, Inc. · 2018
Showing 5 of 83 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 83 · See all- K131634SymbiaSiemens Medical Solutions USA, Inc. · 2013 · cites it directly66descendants
- K142006Symbia 6.0Siemens Medical Solutions USA, Inc. · 2014 · 2 generations on65descendants
- K162483Symbia Intevo BoldSiemens Medical Solutions USA, Inc. · 2017 · 3 generations on63descendants
- K180815MIM - SPECTRA QuantMim Software, Inc. · 2018 · 4 generations on54descendants
- K182624MIM - MRT DosimetryMim Software, Inc. · 2018 · 5 generations on53descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K952674 | Transact: Attenuation Correction System for the Apex Cardial Gamma Camera | Elscint, Inc. | 1995 | 1 |
| −5 | K980959 | Vtransact: Attenuation Correction System for Dual-Head Variable Angle Gamma… | Ge Medical Systems F.I. Haifa | 1998 | — |
| −4 | 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 | — |
| −2 | K063826 | Syngo MI Applications 2007A | Siemens Medical Solutions USA, Inc. | 2007 | — |
| −1 | K072567 | Symbia-E, Model 10275879 | Siemens Medical Solutions USA, Inc. | 2007 | 2 |
| 0 (this device) | K082506 | Symbia, Version 4.0 | Siemens Medical Solutions USA, Inc. | 2008 | — |
| +1 | K131634 | Symbia | Siemens Medical Solutions USA, Inc. | 2013 | 7 |
| +2 | K142006 | Symbia 6.0 | Siemens Medical Solutions USA, Inc. | 2014 | 9 |
| +3 | K162483 | Symbia Intevo Bold | Siemens Medical Solutions USA, Inc. | 2017 | — |
| +4 | K180815 | MIM - SPECTRA Quant | Mim Software, Inc. | 2018 | — |
| +5 | K182624 | MIM - MRT Dosimetry | 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 |
|---|---|---|
| 2009 | 1 | 1 |
| 2010 | 1 | 0 |
| 2011 | 3 | 2 |
| 2012 | 1 | 1 |
| 2013 | 1 | 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 18.6 · 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? (4)
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 |
|---|---|---|---|
| * | K041166 | Siemens Enhanced Imaging SystemSummary page 1…to which Equivalence is claimed Device Manufacturer 510(k) Number Siemens Enhanced Siemens Medical K041166 Imaging Solutions USA, Inc System Symbia E Siemens Medical K072567… | 2004 |
| * | K072567 | Symbia-E, Model 10275879Summary page 1…Siemens Medical K041166 Imaging Solutions USA, Inc System Symbia E Siemens Medical K072567 Solutions USA, Inc syngo Ml Applications Siemens Medical K063826 2007A… | 2007 |
| * | K063826 | Syngo MI Applications 2007ASummary page 1…Siemens Medical K072567 Solutions USA, Inc syngo Ml Applications Siemens Medical K063826 2007A Solutions USA, Inc IP500 Nuclear Gamma Siemens Medical K952109 Camera… | 2007 |
| * | K952109 | IP500 Nuclear Gamma Camera SystemSummary page 1…ations Siemens Medical K063826 2007A Solutions USA, Inc IP500 Nuclear Gamma Siemens Medical K952109 Camera System Solutions USA, Inc QRM10097-T-01 R… | 1995 |
What descends from it? (83)
See all 834 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 |
|---|---|---|---|---|
| Jul 28, 2014 | Class II | Z-2713-2014 | Component design/selection | Siemens Medical Solutions USA, Inc. is performing a field correction because we recently detected a rubber isolator with unfavorable aging properties. The function of the rubber isolator, which is situated within the rotate motor mounting… |
| Jul 28, 2014 | Class II | Z-2712-2014 | Component design/selection | Siemens Medical Solutions USA, Inc. is performing a field correction because we recently detected a rubber isolator with unfavorable aging properties. The function of the rubber isolator, which is situated within the rotate motor mounting… |
| Mar 5, 2014 | Class II | Z-0960-2015 | Component change control | There are confirmed reports of a component coming loose inside the CT enclosure and damaging the system. components. |
| Oct 28, 2013 | Class II | Z-0115-2015 | Process control | Reports of loose bolts in the detector support structure of Symbia and E.CAM systems. |
| Aug 16, 2013 | Class II | Z-0062-2017 | Component design/selection | The detectors on the Symbia S and Symbia T camera systems are supported and moved horizontally and vertically by four linear bearing cars. There is a potential for the linear bearing car to fail allowing the ball bearings to fall out. |
| Oct 23, 2012 | Class II | Z-1087-2015 | Component design/selection | There is a potential for the linear bearing car to fail allowing the ball bearings to fall out. |
| Oct 14, 2011 | Not classified | Z-0283-2012 | Component change control | Errors could potentially impact image interpretation. The acquisition software is exhibiting a defect in the energy window position when an isotope is peaked. There is a potential patient safety issue when running syngo MI Applications… |
| Oct 14, 2011 | Not classified | Z-0284-2012 | Component change control | Errors could potentially impact image interpretation. The acquisition software is exhibiting a defect in the energy window position when an isotope is peaked. There is a potential patient safety issue when running syngo MI Applications… |
| Jun 22, 2011 | Not classified | Z-2980-2011 | Device Design | There a potential patient safety issue when using the Symbia Radiation Therapy Pallet. When a patient is not iso-centered before starting a scan with the Symbia T Series Systems and a non-circular orbit is selected, it is possible that… |
The 5 latest of 9 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.
- 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 · Cites it directly · ◆ in the 2009 descendants bar of FIG. 12 Class I recalls
- K153402Discovery NM/CT 670 CZTGE Healthcare · 2016 · 2 generations on · ◆ in the 2016 descendants bar of FIG. 11 Class I recall
- K173816NM/CT 850, NM/CT 860GE Healthcare · 2018 · 2 generations on · ◆ in the 2018 descendants bar of FIG. 11 Class I recall
- K111445Discovery NM 630GE Healthcare · 2011 · 2 generations on · ◆ in the 2011 descendants bar of FIG. 12 Class I recalls
- K113350Brivo NM 615GE Healthcare · 2011 · 3 generations on · ◆ in the 2011 descendants bar of FIG. 12 Class I recalls
- K121019Optima NM/CT 640GE Healthcare · 2012 · 3 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 13 years and passes through 3 companies; a new generation was cleared every 2.7 years on median.
- 12 of the 19 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K131634 (Siemens Medical Solutions USA, Inc., 2013) has gone furthest, with 66 descendants of its own.
- 2 other devices also cite its predicate K041166.
How does its category compare?
All KPS devicesKPS System, Tomography, Computed, Emission: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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?
The Siemens Symbia series is intended for use by appropriately trained health care professionals to aid in detecting, localizing, diagnosing, staging and restaging of lesions, tumors, disease and organ function for the evaluation of diseases and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. The images produced by the system can also be used by the physician to aid in radiotherapy treatment planning and…
Read the full statement (203 words)
The Siemens Symbia series is intended for use by appropriately trained health care professionals to aid in detecting, localizing, diagnosing, staging and restaging of lesions, tumors, disease and organ function for the evaluation of diseases and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. The images produced by the system can also be used by the physician to aid in radiotherapy treatment planning and interventional radiology procedures.
SPECT: 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
CT: The CT component is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles.
SPECT+CT: Perform CT scans and nuclear imaging studies with the same instrument. To obtain attenuation corrected images and to provide registration of anatomical and physiological images within the patient's anatomy.
Software: The MI Applications software is a display and analysis package intended to aid the clinician in the assessment and quantification of pathologies taken from SPECT, PET, CT and other imaging modalities.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082506 · printed Nov 6, 2026
Cite this page
510(k) Report. “K082506: Symbia, Version 4.0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K082506
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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