510(k) · Cleared
ClearedVERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364); VERITON CT 400 Series Digital SPECT/CT System (VERITON CT 416/464)
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 Jan 13, 2026 as substantially equivalent to K230600 (Spectrum Dynamics Medical, Ltd., 2023) after a 29-day review. Its family tree reaches back 12 generations to 1995. 6 of the 64 devices in its family, counting itself, have a Class I recall.
- Decided
- Jan 13, 2026
- Review
- 29 days
- Class
- Class II
- Product code
- KPS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 12 generations to K952674 (1995). 63 ancestors in all, the oldest K885054 (1989). No later device cites it as a predicate yet. 6 of the 64 devices in this family, counting this one, have a Class I recall.
- Root · 12 generations backK952674 Transact: Attenuation Correction System for the Apex Cardial Gamma…Elscint, Inc. · 1995 · Recalled
- 8 generations between
- 3 generations backK182484 VERITON CT whole body SPECT/CT systemSpectrum Dynamics Medical, Ltd. · 2018
- 2 generations backK190457 VERITON CT whole body SPECT/CT systemSpectrum Dynamics Medical, Ltd. · 2019
- 1 generation backK230600 VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364)…Spectrum Dynamics Medical, Ltd. · 2023
- This deviceK254001 VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364)…Spectrum Dynamics Medical, Ltd. · 2026
Show all 12 generations
- Root · 12 generations backK952674 Transact: Attenuation Correction System for the Apex Cardial Gamma…Elscint, Inc. · 1995 · Recalled
- 11 generations backK980959 Vtransact: Attenuation Correction System for Dual-Head Variable…Ge Medical Systems F.I. Haifa · 1998
- 10 generations backK991841 Hawkeye Option for Dual-Head Variable Angle Gamma CameraGe Medical Systems F.I. Haifa · 1999 · Recalled (Class I)
- 9 generations backK023190 E.Cam Computer / E.Soft WorkstationSiemens Medical Solutions USA, Inc. · 2002
- 8 generations backK063826 Syngo MI Applications 2007ASiemens Medical Solutions USA, Inc. · 2007
- 7 generations backK072567 Symbia-E, Model 10275879Siemens Medical Solutions USA, Inc. · 2007 · Recalled
- 6 generations backK082506 Symbia, Version 4.0Siemens Medical Solutions USA, Inc. · 2008 · Recalled
- 5 generations backK093514 Discovery Model NM/CT 670Ge Medical Systems F.I. Haifa · 2009 · Recalled (Class I)
- 4 generations backK153402 Discovery NM/CT 670 CZTGE Healthcare · 2016 · Recalled (Class I)
- 3 generations backK182484 VERITON CT whole body SPECT/CT systemSpectrum Dynamics Medical, Ltd. · 2018
- 2 generations backK190457 VERITON CT whole body SPECT/CT systemSpectrum Dynamics Medical, Ltd. · 2019
- 1 generation backK230600 VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364)…Spectrum Dynamics Medical, Ltd. · 2023
- This deviceK254001 VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364)…Spectrum Dynamics Medical, Ltd. · 2026
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K952674 | Transact: Attenuation Correction System for the Apex Cardial Gamma Camera | Elscint, Inc. | 1995 | 1 |
| −11 | K980959 | Vtransact: Attenuation Correction System for Dual-Head Variable Angle Gamma… | Ge Medical Systems F.I. Haifa | 1998 | — |
| −10 | K991841 | Hawkeye Option for Dual-Head Variable Angle Gamma Camera | Ge Medical Systems F.I. Haifa | 1999 | Class I |
| −9 | K023190 | E.Cam Computer / E.Soft Workstation | Siemens Medical Solutions USA, Inc. | 2002 | — |
| −8 | K063826 | Syngo MI Applications 2007A | Siemens Medical Solutions USA, Inc. | 2007 | — |
| −7 | K072567 | Symbia-E, Model 10275879 | Siemens Medical Solutions USA, Inc. | 2007 | 2 |
| −6 | K082506 | Symbia, Version 4.0 | Siemens Medical Solutions USA, Inc. | 2008 | 9 |
| −5 | K093514 | Discovery Model NM/CT 670 | Ge Medical Systems F.I. Haifa | 2009 | Class I |
| −4 | K153402 | Discovery NM/CT 670 CZT | GE Healthcare | 2016 | Class I |
| −3 | K182484 | VERITON CT whole body SPECT/CT system | Spectrum Dynamics Medical, Ltd. | 2018 | — |
| −2 | 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 | — |
| 0 (this device) | 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 |
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 |
|---|---|---|---|
| * | K230600 | VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364); VERITON CT 400…Summary page 5…d Tomography (CT) system Predicate device: Predicate Device: VERITON CT 300/400 Series Digital SPECT/CT System Sponsor: Spectrum Dynamics Medical Ltd. 510(k) Number: K230600 The predicate has not been withdrawn or found to be unsafe or ineffective. Device Description: The VERITON CT 300/400 Digital… | 2023 |
| † | K233620 | MIM - Centiloid Scaling | 2024 |
What descends from it?
No later submission names this one as a predicate yet.
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 · 4 generations back · ◆ on the line of descent in FIG. 11 Class I recall
- K093514Discovery Model NM/CT 670Ge Medical Systems F.I. Haifa · 2009 · 5 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 · 6 generations back · ◆ in the 2005 ancestors bar of FIG. 11 Class I recall
- K022960GE Quasar Nuclear Medicine SystemGe Medical Systems F.I. Haifa · 2002 · 6 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 · 7 generations back · ◆ on the line of descent in FIG. 11 Class I recall
- K953801VaricamElscint, Inc. · 1995 · 7 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 31 years and passes through 5 companies; a new generation was cleared every 2.7 years on median.
- 27 of the 63 ancestors have a recall of any class; 6 have 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?
Spectrum Dynamics Medical's VERITON system is intended for use by trained healthcare professionals to aid in the detection, localization, diagnosis, staging and restaging of lesions, diseases, and organ function. For evaluating diseases and disorders such as cardiovascular disease, neurological disorders, and trauma. System outcomes can be used to plan, guide, and monitor therapy. SPECT: The SPECT component is intended to detect or image the distribution…
Read the full statement (159 words)
Spectrum Dynamics Medical's VERITON system is intended for use by trained healthcare professionals to
aid in the detection, localization, diagnosis, staging and restaging of lesions, diseases, and organ function.
For evaluating diseases and disorders such as cardiovascular disease, neurological disorders, and trauma.
System outcomes can be used to plan, guide, and monitor 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.
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 as stated in the FDA summary.
https://510kreport.com/device/K254001 · printed Nov 6, 2026
Cite this page
510(k) Report. “K254001: VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364); VERITON CT 400 Series Digital SPECT/CT System (VERITON CT 416/464).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K254001
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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