FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇱 Israel
VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364); VERITON CT 400 Series Digital SPECT/CT System (VERITON CT 416/464)
K Number: K254001
·
Decision Jan 13, 2026
Classifications
1
FEI Numbers
85
Registration Numbers
85
Same Product Code
470
Applicant Total
8
Review Days
29
Basic Information
- Device Name
- VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364); VERITON CT 400 Series Digital SPECT/CT System (VERITON CT 416/464)
- K Number
- K254001
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 892.1200
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Spectrum Dynamics Medical, Ltd.
- Date Received
- December 15, 2025
- Decision Date
- January 13, 2026
- Product Code
- KPS
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| KPS | System, Tomography, Computed, Emission | FDA class 2 | Radiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KPS), ordered by most recent decision date.
Symbia Pro.specta Q3 (11364751);Symbia Pro.specta X3 (11364752);Symbia Pro.specta X7 (11364753);Symbia Pro.specta VA40 Family
FDA 510(k)
FDA Class 2
·Radiology
uMI Panvivo (uMI Panvivo LS); uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S); uMI Panvivo (uMI Panvivo EX); uMI Panvivo (uMI Panvivo ES)
FDA 510(k)
FDA Class 2
·Radiology
uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S); uMI Panvivo (uMI Panvivo EX); uMI Panvivo (uMI Panvivo ES)
FDA 510(k)
FDA Class 2
·Radiology
AnyScan 3.0 NM Scanner Family
FDA 510(k)
FDA Class 2
·Radiology
Cartesion Prime (PCD-1000A/3) V10.21
FDA 510(k)
FDA Class 2
·Radiology
PennPET Explorer Positron Emission Tomograph
FDA 510(k)
FDA Class 2
·Radiology
Other Clearances by Spectrum Dynamics Medical, Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K253532 | TruSPECT Processing Station | Dec 30, 2025 | Substantially Equivalent |
| K230600 | VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364); VERITON CT 400 Series Digital SPECT/CT System (VERITON CT 416/464) | Apr 28, 2023 | Substantially Equivalent |
| K212230 | TruSPECT Radiological Image Processing Station | Aug 16, 2021 | Substantially Equivalent |
| K190457 | VERITON CT whole body SPECT/CT system | Jul 12, 2019 | Substantially Equivalent |
| K182484 | VERITON CT whole body SPECT/CT system | Nov 9, 2018 | Substantially Equivalent |
| K180514 | VERITON NM | Apr 25, 2018 | Substantially Equivalent |
| K161740 | D-SPECT Scanner, D-SPECT L Scanner | Nov 4, 2016 | Substantially Equivalent |