510(k) · Cleared
Recalled · Class II · 2018Symbia 6.5
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 Sep 8, 2016 as substantially equivalent to K142006 (Siemens Medical Solutions USA, Inc., 2014) after a 17-day review. Its family tree reaches back 9 generations to 1995. 1 of the 31 devices in its family, counting itself, has a Class I recall. 8 later devices descend from it. It has been recalled 4 times.
- Decided
- Sep 8, 2016
- Review
- 17 days
- Class
- Class II
- Product code
- KPS
- Recalls
- 4
- Predicates
- 1
Its longest line of descent runs back 9 generations to K952674 (1995). 22 ancestors in all, the oldest K892358 (1989). 8 later devices descend from it, 1 citing it directly. 1 of the 31 devices in this family, counting this one, has a Class I recall.
- Root · 9 generations backK952674 Transact: Attenuation Correction System for the Apex Cardial Gamma…Elscint, Inc. · 1995 · Recalled
- 5 generations between
- 3 generations backK082506 Symbia, Version 4.0Siemens Medical Solutions USA, Inc. · 2008 · Recalled
- 2 generations backK131634 SymbiaSiemens Medical Solutions USA, Inc. · 2013 · Recalled
- 1 generation backK142006 Symbia 6.0Siemens Medical Solutions USA, Inc. · 2014 · Recalled
- This deviceK162337 Symbia 6.5Siemens Medical Solutions USA, Inc. · 2016
- Descendant · cites it directly · 7 of its ownK200474 Symbia 6.7Siemens Medical Solutions USA, Inc. · 2020 · Recalled
- Descendant · 2 generations on · 4 of its ownK210557 Symbia VA10A FamilySiemens Medical Solutions USA, Inc. · 2021
- Descendant · 3 generations on · 3 of its ownK212604 Symbia VA10A FamilySiemens Medical Solutions USA, Inc. · 2021 · Recalled
- Descendant · 4 generations on · 2 of its ownK231102 Symbia Pro.specta VA20A FamilySiemens Medical Solutions USA, Inc. · 2023
- Descendant · 5 generations on · 1 of its ownK243186 Symbia Pro.specta Q3 (11364751); Symbia Pro.specta X3 (11364752)…Siemens Medical Solutions USA, Inc. · 2024
Show all 9 generations
- Root · 9 generations backK952674 Transact: Attenuation Correction System for the Apex Cardial Gamma…Elscint, Inc. · 1995 · Recalled
- 8 generations backK980959 Vtransact: Attenuation Correction System for Dual-Head Variable…Ge Medical Systems F.I. Haifa · 1998
- 7 generations backK991841 Hawkeye Option for Dual-Head Variable Angle Gamma CameraGe Medical Systems F.I. Haifa · 1999 · Recalled (Class I)
- 6 generations backK023190 E.Cam Computer / E.Soft WorkstationSiemens Medical Solutions USA, Inc. · 2002
- 5 generations backK063826 Syngo MI Applications 2007ASiemens Medical Solutions USA, Inc. · 2007
- 4 generations backK072567 Symbia-E, Model 10275879Siemens Medical Solutions USA, Inc. · 2007 · Recalled
- 3 generations backK082506 Symbia, Version 4.0Siemens Medical Solutions USA, Inc. · 2008 · Recalled
- 2 generations backK131634 SymbiaSiemens Medical Solutions USA, Inc. · 2013 · Recalled
- 1 generation backK142006 Symbia 6.0Siemens Medical Solutions USA, Inc. · 2014 · Recalled
- This deviceK162337 Symbia 6.5Siemens Medical Solutions USA, Inc. · 2016
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K991841 Hawkeye Option for Dual-Head Variable Angle…5 generations back · 1999
Most influential descendants
Showing 5 of 8 · See all- K200474Symbia 6.7Siemens Medical Solutions USA, Inc. · 2020 · cites it directly7descendants
- K210557Symbia VA10A FamilySiemens Medical Solutions USA, Inc. · 2021 · 2 generations on4descendants
- K212604Symbia VA10A FamilySiemens Medical Solutions USA, Inc. · 2021 · 3 generations on3descendants
- K231102Symbia Pro.specta VA20A FamilySiemens Medical Solutions USA, Inc. · 2023 · 4 generations on2descendants
- K243186Symbia Pro.specta Q3 (11364751); Symbia Pro.specta X3 (11364752); Symbia Pro.specta X7…Siemens Medical Solutions USA, Inc. · 2024 · 5 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K952674 | Transact: Attenuation Correction System for the Apex Cardial Gamma Camera | Elscint, Inc. | 1995 | 1 |
| −8 | K980959 | Vtransact: Attenuation Correction System for Dual-Head Variable Angle Gamma… | Ge Medical Systems F.I. Haifa | 1998 | — |
| −7 | K991841 | Hawkeye Option for Dual-Head Variable Angle Gamma Camera | Ge Medical Systems F.I. Haifa | 1999 | Class I |
| −6 | K023190 | E.Cam Computer / E.Soft Workstation | Siemens Medical Solutions USA, Inc. | 2002 | — |
| −5 | K063826 | Syngo MI Applications 2007A | Siemens Medical Solutions USA, Inc. | 2007 | — |
| −4 | K072567 | Symbia-E, Model 10275879 | Siemens Medical Solutions USA, Inc. | 2007 | 2 |
| −3 | K082506 | Symbia, Version 4.0 | Siemens Medical Solutions USA, Inc. | 2008 | 9 |
| −2 | K131634 | Symbia | Siemens Medical Solutions USA, Inc. | 2013 | 7 |
| −1 | K142006 | Symbia 6.0 | Siemens Medical Solutions USA, Inc. | 2014 | 9 |
| 0 (this device) | K162337 | Symbia 6.5 | Siemens Medical Solutions USA, Inc. | 2016 | — |
| +1 | K200474 | Symbia 6.7 | Siemens Medical Solutions USA, Inc. | 2020 | 2 |
| +2 | K210557 | Symbia VA10A Family | Siemens Medical Solutions USA, Inc. | 2021 | — |
| +3 | K212604 | Symbia VA10A Family | Siemens Medical Solutions USA, Inc. | 2021 | 1 |
| +4 | K231102 | Symbia Pro.specta VA20A Family | Siemens Medical Solutions USA, Inc. | 2023 | — |
| +5 | K243186 | Symbia Pro.specta Q3 (11364751); Symbia Pro.specta X3 (11364752); Symbia… | Siemens Medical Solutions USA, Inc. | 2024 | — |
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 |
|---|---|---|
| 2020 | 1 | 0 |
| 2021 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 1 | 0 |
| 2026 | 1 | 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.
1 device in this family has 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? (1)
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.
What descends from it? (8)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K200474 | Symbia 6.7 | 2020 | 7 |
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 5, 2018 | Class II | Z-0372-2019 | Other | The Evo Excel External-ECG Power-Connection current limit is mis-labeled as 1.0A. It should be labeled 0.55A., |
| Nov 7, 2017 | Class II | Z-0094-2018 | Software design | The Broad Quantification option of the Symbia product software version VB20A may not allow modification of two data input values. The failure occurs when the system with the Broad Quantification option is calibrated with phantoms that do… |
| Nov 7, 2017 | Class II | Z-0093-2018 | Software design | The Broad Quantification option of the Symbia product software version VB20A may not allow modification of two data input values. The failure occurs when the system with the Broad Quantification option is calibrated with phantoms that do… |
| Sep 18, 2017 | Class II | Z-0047-2018 | Equipment maintenance | The torque wrench used to tighten system bolts during installation was found to be out of tolerance |
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 · 5 generations back · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 21 years and passes through 3 companies; a new generation was cleared every 2.1 years on median.
- 15 of the 22 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K200474 (Siemens Medical Solutions USA, Inc., 2020) has gone furthest, with 7 descendants of its own.
- 1 other device also cites its predicate K142006.
How does its category compare?
All KPS devicesKPS System, Tomography, Computed, Emission: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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 (224 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: The SPECT component is intended to detect or image the distribution of radionuclides in the body or organ (physiology), using the following techniques; Planar imaging, whole body imaging, and tomographic imaging for isotopes with energies up to 588 keV.
CT: The CT component is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data (anatomy) from either the same axial plane taken at different angles or spiral planes take at different angles.
SPECT+CT: The SPECT and CT components used together acquire SPECT/CT images. The SPECT images can be corrected for attenuation with the CT images, and can be combined (image registration) to merge the patient's physiological (SPECT) and anatomical (CT) images.
Software: the syngo MI Applications software is a display and analysis package intended to aid the clinician in the assessment and quantification of pathologies in images produced from SPECT, PET, CT and other imaging modalities.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K162337 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162337: Symbia 6.5.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K162337
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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