510(k) · Cleared
ClearedSymbia T16, Symbia Intevo 16 and Symbia Intevo Bold
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 17, 2017 as substantially equivalent to K142955 (Siemens Medical Solutions USA, Inc., 2015) after a 50-day review. Its family tree reaches back 9 generations to 2001.
- Decided
- Nov 17, 2017
- Review
- 50 days
- Class
- Class II
- Product code
- KPS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K013561 (2001). 30 ancestors in all, the oldest K940606 (1994). No later device cites it as a predicate yet.
- Root · 9 generations backK013561 Lightspeed 4.0 CT Scanner SystemGE Medical Systems · 2001 · Recalled
- 5 generations between
- 3 generations backK121072 Somatom Definition FlashSiemens Medical Systems, Inc. · 2012 · Recalled
- 2 generations backK133589 Somatom ForceSiemens Medical Solutions USA, Inc. · 2014 · Recalled
- 1 generation backK142955 SOMATOM Force, SOMATOM Definition Flash, SOMATOM Definition Edge…Siemens Medical Solutions USA, Inc. · 2015 · Recalled
- This deviceK173023 Symbia T16, Symbia Intevo 16 and Symbia Intevo BoldSiemens Medical Solutions USA, Inc. · 2017
Show all 9 generations
- Root · 9 generations backK013561 Lightspeed 4.0 CT Scanner SystemGE Medical Systems · 2001 · Recalled
- 8 generations backK030420 Lightspeed 5.0 Computed Tomography SystemGE Medical Systems · 2003 · Recalled
- 7 generations backK040372 Lightspeed 7.0 CT Scanner SystemGe Medical Systems, LLC · 2004 · Recalled
- 6 generations backK052216 Somatom DefinitionSiemens Medical Systems, Inc. · 2005
- 5 generations backK082220 Somatom Flash DSSiemens Medical Solutions USA, Inc. · 2008
- 4 generations backK113342 Somatom Definition FlashSiemens Medical Systems, Inc. · 2011 · Recalled
- 3 generations backK121072 Somatom Definition FlashSiemens Medical Systems, Inc. · 2012 · Recalled
- 2 generations backK133589 Somatom ForceSiemens Medical Solutions USA, Inc. · 2014 · Recalled
- 1 generation backK142955 SOMATOM Force, SOMATOM Definition Flash, SOMATOM Definition Edge…Siemens Medical Solutions USA, Inc. · 2015 · Recalled
- This deviceK173023 Symbia T16, Symbia Intevo 16 and Symbia Intevo BoldSiemens Medical Solutions USA, Inc. · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K013561 | Lightspeed 4.0 CT Scanner System | GE Medical Systems | 2001 | 5 |
| −8 | K030420 | Lightspeed 5.0 Computed Tomography System | GE Medical Systems | 2003 | 4 |
| −7 | K040372 | Lightspeed 7.0 CT Scanner System | Ge Medical Systems, LLC | 2004 | 5 |
| −6 | K052216 | Somatom Definition | Siemens Medical Systems, Inc. | 2005 | — |
| −5 | K082220 | Somatom Flash DS | Siemens Medical Solutions USA, Inc. | 2008 | — |
| −4 | K113342 | Somatom Definition Flash | Siemens Medical Systems, Inc. | 2011 | 1 |
| −3 | K121072 | Somatom Definition Flash | Siemens Medical Systems, Inc. | 2012 | 5 |
| −2 | K133589 | Somatom Force | Siemens Medical Solutions USA, Inc. | 2014 | 9 |
| −1 | K142955 | SOMATOM Force, SOMATOM Definition Flash, SOMATOM Definition Edge, SOMATOM… | Siemens Medical Solutions USA, Inc. | 2015 | 16 |
| 0 (this device) | K173023 | Symbia T16, Symbia Intevo 16 and Symbia Intevo Bold | Siemens Medical Solutions USA, Inc. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1998 | 3 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 3 | 0 |
| 2014 | 4 | 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.
Planning a device in KPS? 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K142955 | SOMATOM Force, SOMATOM Definition Flash, SOMATOM Definition Edge, SOMATOM Definition…Summary page 5…Siemens Medical Solutions USA, Inc. Product Code: 90 JAK Device Class: Class II 510(k) Number: K142955 Reference Devices: Device Proprietary Symbia T16 Symbia Intevo 16 Symbia Intevo Bold Name:… | 2015 |
| † | K162337 | Symbia 6.5 | 2016 |
| † | K162483 | Symbia Intevo Bold | 2017 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 16 years and passes through 4 companies; a new generation was cleared every 1.6 years on median.
- 23 of the 30 ancestors have a recall of any class.
- 4 other devices also cite its predicate K142955.
How does its category compare?
All KPS devicesKPS System, Tomography, Computed, Emission: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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 (271 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 :MIApplications 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.
The following statement applies only to the Siemens Symbia Tl 6, Siemens Symbia lntevo 16 and Siemens Symbia Intevo Bold systems. This CT system can be used for low dose lung cancer screening in high risk populations.*
*As defined by professional medical societies. Please refer to clinical literature, including the results of the National Lung Screening Trial (N Engl J Med 2011; 365:395-409) and subsequent literature, for further information.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K173023 · printed Nov 6, 2026
Cite this page
510(k) Report. “K173023: Symbia T16, Symbia Intevo 16 and Symbia Intevo Bold.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K173023
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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