510(k) · Cleared
ClearedVERITON CT whole body SPECT/CT system
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spectrum Dynamics Medical, Ltd. · KPS System, Tomography, Computed, Emission
Cleared on Jul 12, 2019 as substantially equivalent to K182484 (Spectrum Dynamics Medical, Ltd., 2018) after a 137-day review. Its family tree reaches back 10 generations to 1995. 6 of the 64 devices in its family, counting itself, have a Class I recall. 2 later devices descend from it.
- Decided
- Jul 12, 2019
- Review
- 137 days
- Class
- Class II
- Product code
- KPS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K952674 (1995). 61 ancestors in all, the oldest K885054 (1989). 2 later devices descend from it, 1 citing it directly. 6 of the 64 devices in this family, counting this one, have a Class I recall.
- Root · 10 generations backK952674 Transact: Attenuation Correction System for the Apex Cardial Gamma…Elscint, Inc. · 1995 · Recalled
- 6 generations between
- 3 generations backK093514 Discovery Model NM/CT 670Ge Medical Systems F.I. Haifa · 2009 · Recalled (Class I)
- 2 generations backK153402 Discovery NM/CT 670 CZTGE Healthcare · 2016 · Recalled (Class I)
- 1 generation backK182484 VERITON CT whole body SPECT/CT systemSpectrum Dynamics Medical, Ltd. · 2018
- This deviceK190457 VERITON CT whole body SPECT/CT systemSpectrum Dynamics Medical, Ltd. · 2019
- Descendant · cites it directly · 1 of its ownK230600 VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364)…Spectrum Dynamics Medical, Ltd. · 2023
- Descendant · 2 generations on · 0 of its ownK254001 VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364)…Spectrum Dynamics Medical, Ltd. · 2026
Show all 10 generations
- Root · 10 generations backK952674 Transact: Attenuation Correction System for the Apex Cardial Gamma…Elscint, Inc. · 1995 · Recalled
- 9 generations backK980959 Vtransact: Attenuation Correction System for Dual-Head Variable…Ge Medical Systems F.I. Haifa · 1998
- 8 generations backK991841 Hawkeye Option for Dual-Head Variable Angle Gamma CameraGe Medical Systems F.I. Haifa · 1999 · Recalled (Class I)
- 7 generations backK023190 E.Cam Computer / E.Soft WorkstationSiemens Medical Solutions USA, Inc. · 2002
- 6 generations backK063826 Syngo MI Applications 2007ASiemens Medical Solutions USA, Inc. · 2007
- 5 generations backK072567 Symbia-E, Model 10275879Siemens Medical Solutions USA, Inc. · 2007 · Recalled
- 4 generations backK082506 Symbia, Version 4.0Siemens Medical Solutions USA, Inc. · 2008 · Recalled
- 3 generations backK093514 Discovery Model NM/CT 670Ge Medical Systems F.I. Haifa · 2009 · Recalled (Class I)
- 2 generations backK153402 Discovery NM/CT 670 CZTGE Healthcare · 2016 · Recalled (Class I)
- 1 generation backK182484 VERITON CT whole body SPECT/CT systemSpectrum Dynamics Medical, Ltd. · 2018
- This deviceK190457 VERITON CT whole body SPECT/CT systemSpectrum Dynamics Medical, Ltd. · 2019
Class I recalls in this family
Most influential descendants
Showing 2 of 2 · See all- K230600VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364); VERITON CT 400…Spectrum Dynamics Medical, Ltd. · 2023 · cites it directly1descendant
- K254001VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364); VERITON CT 400…Spectrum Dynamics Medical, Ltd. · 2026 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K952674 | Transact: Attenuation Correction System for the Apex Cardial Gamma Camera | Elscint, Inc. | 1995 | 1 |
| −9 | K980959 | Vtransact: Attenuation Correction System for Dual-Head Variable Angle Gamma… | Ge Medical Systems F.I. Haifa | 1998 | — |
| −8 | K991841 | Hawkeye Option for Dual-Head Variable Angle Gamma Camera | Ge Medical Systems F.I. Haifa | 1999 | Class I |
| −7 | K023190 | E.Cam Computer / E.Soft Workstation | Siemens Medical Solutions USA, Inc. | 2002 | — |
| −6 | K063826 | Syngo MI Applications 2007A | Siemens Medical Solutions USA, Inc. | 2007 | — |
| −5 | K072567 | Symbia-E, Model 10275879 | Siemens Medical Solutions USA, Inc. | 2007 | 2 |
| −4 | K082506 | Symbia, Version 4.0 | Siemens Medical Solutions USA, Inc. | 2008 | 9 |
| −3 | K093514 | Discovery Model NM/CT 670 | Ge Medical Systems F.I. Haifa | 2009 | Class I |
| −2 | K153402 | Discovery NM/CT 670 CZT | GE Healthcare | 2016 | Class I |
| −1 | K182484 | VERITON CT whole body SPECT/CT system | Spectrum Dynamics Medical, Ltd. | 2018 | — |
| 0 (this device) | K190457 | VERITON CT whole body SPECT/CT system | Spectrum Dynamics Medical, Ltd. | 2019 | — |
| +1 | K230600 | VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364); VERITON CT… | Spectrum Dynamics Medical, Ltd. | 2023 | — |
| +2 | K254001 | VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364); VERITON CT… | Spectrum Dynamics Medical, Ltd. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 2 | 0 |
| 1991 | 3 | 0 |
| 1994 | 1 | 0 |
| 1995 | 3 | 1 |
| 1997 | 3 | 0 |
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 6 | 0 |
| 2001 | 3 | 0 |
| 2002 | 3 | 1 |
| 2003 | 5 | 0 |
| 2004 | 5 | 0 |
| 2005 | 4 | 1 |
| 2006 | 3 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2011 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 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.
6 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? (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 |
|---|---|---|---|
| * | K182484 | VERITON CT whole body SPECT/CT systemSummary page 4…Il KPS and JAK Radiology Emission Computed Tomography per 21 CFR 892.1200 The Spectrum Dynamics VERITON® CT 16 system is a modification to the VERITON® CT 64 system (K182484), the difference between the two models in the CT configuration used, 16 slices in compare to 64 in predicate. All other items in… | 2018 |
| † | K182147 | CTXX85 | 2018 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K230600 | VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364); VERITON CT 400… | 2023 | 1 |
Has anything in its family been recalled? (6 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.
- K153402Discovery NM/CT 670 CZTGE Healthcare · 2016 · 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 · 3 generations back · ◆ on the line of descent in FIG. 12 Class I recalls
- K052434Hawkeye 4 Option for Dual-Head Variable Angle Gamma CameraGE Medical Systems · 2005 · 4 generations back · ◆ in the 2005 ancestors bar of FIG. 11 Class I recall
- K022960GE Quasar Nuclear Medicine SystemGe Medical Systems F.I. Haifa · 2002 · 4 generations back · ◆ in the 2002 ancestors bar of FIG. 11 Class I recall
- 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
- K953801VaricamElscint, Inc. · 1995 · 5 generations back · ◆ in the 1995 ancestors bar of FIG. 11 Class I recall
Nearest 5 of 6; all are on the web page.
What does this lineage say?
- The line of descent spans 24 years and passes through 5 companies; a new generation was cleared every 2.7 years on median.
- 27 of the 61 ancestors have a recall of any class; 6 have a Class I recall.
- Of its descendants, K230600 (Spectrum Dynamics Medical, Ltd., 2023) has gone furthest, with 1 descendant of its own.
How does its category compare?
All KPS devicesKPS System, Tomography, Computed, Emission: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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 Spectrum Dynamics Medical’s VERITON™ CT is intended for use by appropriately trained health care professionals to aid in detecting, localizing, diagnosing, staging and restaging of lesions, disease and organ function for the evaluation of diseases and disorders such as, but not limited to, cardiovascular disease, neurological disorders and trauma. The system output can be used for planning, guiding, and monitoring therapy. SPECT: The SPECT component…
Read the full statement (178 words)
The Spectrum Dynamics Medical’s VERITON™ CT is intended for use by appropriately trained health care professionals to aid in detecting, localizing, diagnosing, staging and restaging of lesions, disease and organ function for the evaluation of diseases and disorders such as, but not limited to, cardiovascular disease, neurological disorders and trauma. The system output can be used for planning, guiding, and monitoring therapy.
SPECT: The SPECT component is intended to detect or image the distribution of radionuclides in the body or organ (physiology), using the following techniques; whole body and tomographic imaging.
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. The CT part is indicated for pediatric and adult patients.
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.
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/K190457 · printed Nov 4, 2026
Cite this page
510(k) Report. “K190457: VERITON CT whole body SPECT/CT system.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K190457
Report an extraction error
Are you the manufacturer?
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