510(k) · Cleared
ClearedSymbia Pro.specta Q3 (11364751);Symbia Pro.specta X3 (11364752);Symbia Pro.specta X7 (11364753);Symbia Pro.specta VA40 Family
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 May 21, 2026 as substantially equivalent to K243186 (Siemens Medical Solutions USA, Inc., 2024) after a 30-day review. Its family tree reaches back 15 generations to 1995. 1 of the 30 devices in its family, counting itself, has a Class I recall.
- Decided
- May 21, 2026
- Review
- 30 days
- Class
- Class II
- Product code
- KPS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 15 generations to K952674 (1995). 29 ancestors in all, the oldest K892358 (1989). No later device cites it as a predicate yet. 1 of the 30 devices in this family, counting this one, has a Class I recall.
- Root · 15 generations backK952674 Transact: Attenuation Correction System for the Apex Cardial Gamma…Elscint, Inc. · 1995 · Recalled
- 11 generations between
- 3 generations backK212604 Symbia VA10A FamilySiemens Medical Solutions USA, Inc. · 2021 · Recalled
- 2 generations backK231102 Symbia Pro.specta VA20A FamilySiemens Medical Solutions USA, Inc. · 2023
- 1 generation backK243186 Symbia Pro.specta Q3 (11364751); Symbia Pro.specta X3 (11364752)…Siemens Medical Solutions USA, Inc. · 2024
- This deviceK261315 Symbia Pro.specta Q3 (11364751);Symbia Pro.specta X3…Siemens Medical Solutions USA, Inc. · 2026
Show all 15 generations
- Root · 15 generations backK952674 Transact: Attenuation Correction System for the Apex Cardial Gamma…Elscint, Inc. · 1995 · Recalled
- 14 generations backK980959 Vtransact: Attenuation Correction System for Dual-Head Variable…Ge Medical Systems F.I. Haifa · 1998
- 13 generations backK991841 Hawkeye Option for Dual-Head Variable Angle Gamma CameraGe Medical Systems F.I. Haifa · 1999 · Recalled (Class I)
- 12 generations backK023190 E.Cam Computer / E.Soft WorkstationSiemens Medical Solutions USA, Inc. · 2002
- 11 generations backK063826 Syngo MI Applications 2007ASiemens Medical Solutions USA, Inc. · 2007
- 10 generations backK072567 Symbia-E, Model 10275879Siemens Medical Solutions USA, Inc. · 2007 · Recalled
- 9 generations backK082506 Symbia, Version 4.0Siemens Medical Solutions USA, Inc. · 2008 · Recalled
- 8 generations backK131634 SymbiaSiemens Medical Solutions USA, Inc. · 2013 · Recalled
- 7 generations backK142006 Symbia 6.0Siemens Medical Solutions USA, Inc. · 2014 · Recalled
- 6 generations backK162337 Symbia 6.5Siemens Medical Solutions USA, Inc. · 2016 · Recalled
- 5 generations backK200474 Symbia 6.7Siemens Medical Solutions USA, Inc. · 2020 · Recalled
- 4 generations backK210557 Symbia VA10A FamilySiemens Medical Solutions USA, Inc. · 2021
- 3 generations backK212604 Symbia VA10A FamilySiemens Medical Solutions USA, Inc. · 2021 · Recalled
- 2 generations backK231102 Symbia Pro.specta VA20A FamilySiemens Medical Solutions USA, Inc. · 2023
- 1 generation backK243186 Symbia Pro.specta Q3 (11364751); Symbia Pro.specta X3 (11364752)…Siemens Medical Solutions USA, Inc. · 2024
- This deviceK261315 Symbia Pro.specta Q3 (11364751);Symbia Pro.specta X3…Siemens Medical Solutions USA, Inc. · 2026
Class I recalls in this family
- K991841 Hawkeye Option for Dual-Head Variable Angle…11 generations back · 1999
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K952674 | Transact: Attenuation Correction System for the Apex Cardial Gamma Camera | Elscint, Inc. | 1995 | 1 |
| −14 | K980959 | Vtransact: Attenuation Correction System for Dual-Head Variable Angle Gamma… | Ge Medical Systems F.I. Haifa | 1998 | — |
| −13 | K991841 | Hawkeye Option for Dual-Head Variable Angle Gamma Camera | Ge Medical Systems F.I. Haifa | 1999 | Class I |
| −12 | K023190 | E.Cam Computer / E.Soft Workstation | Siemens Medical Solutions USA, Inc. | 2002 | — |
| −11 | K063826 | Syngo MI Applications 2007A | Siemens Medical Solutions USA, Inc. | 2007 | — |
| −10 | K072567 | Symbia-E, Model 10275879 | Siemens Medical Solutions USA, Inc. | 2007 | 2 |
| −9 | K082506 | Symbia, Version 4.0 | Siemens Medical Solutions USA, Inc. | 2008 | 9 |
| −8 | K131634 | Symbia | Siemens Medical Solutions USA, Inc. | 2013 | 7 |
| −7 | K142006 | Symbia 6.0 | Siemens Medical Solutions USA, Inc. | 2014 | 9 |
| −6 | K162337 | Symbia 6.5 | Siemens Medical Solutions USA, Inc. | 2016 | 4 |
| −5 | K200474 | Symbia 6.7 | Siemens Medical Solutions USA, Inc. | 2020 | 2 |
| −4 | K210557 | Symbia VA10A Family | Siemens Medical Solutions USA, Inc. | 2021 | — |
| −3 | K212604 | Symbia VA10A Family | Siemens Medical Solutions USA, Inc. | 2021 | 1 |
| −2 | K231102 | Symbia Pro.specta VA20A Family | Siemens Medical Solutions USA, Inc. | 2023 | — |
| −1 | K243186 | Symbia Pro.specta Q3 (11364751); Symbia Pro.specta X3 (11364752); Symbia… | Siemens Medical Solutions USA, Inc. | 2024 | — |
| 0 (this device) | K261315 | Symbia Pro.specta Q3 (11364751);Symbia Pro.specta X3 (11364752);Symbia… | Siemens Medical Solutions USA, Inc. | 2026 | — |
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 |
| 2017 | 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K243186 | Symbia Pro.specta Q3 (11364751); Symbia Pro.specta X3 (11364752); Symbia Pro.specta X7…Summary page 6…Code: KPS and JAK Classification Panel: Radiology Device Class: Class II 510(k) Number: K243186 Reference Device: Device Name and 510(k) SOMATOM Go.Platform numbers: Common Name: Compu… | 2024 |
| † | K250822 | SOMATOM go.Now; SOMATOM go.Up; SOMATOM go.All; SOMATOM go.Top; SOMATOM go.Sim; SOMATOM… | 2025 |
| † | K254016 | MI View&GO | 2026 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
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 · 11 generations back · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 31 years and passes through 3 companies; a new generation was cleared every 1.6 years on median.
- 18 of the 29 ancestors have a recall of any class; 1 has a Class I recall.
How does its category compare?
All KPS devicesKPS System, Tomography, Computed, Emission: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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 Symbia Pro.specta systems are 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…
Read the full statement (275 words)
The Symbia Pro.specta systems are 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 or additional uses.
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 taken 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 SPECTsyngo software is an acquisition, 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.
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.
There are no known contraindications.
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/K261315 · printed Nov 6, 2026
Cite this page
510(k) Report. “K261315: Symbia Pro.specta Q3 (11364751);Symbia Pro.specta X3 (11364752);Symbia Pro.specta X7 (11364753);Symbia Pro.specta VA40 Family.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K261315
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026