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: K230600
·
Decision Apr 28, 2023
Classifications
1
FEI Numbers
85
Registration Numbers
85
Same Product Code
470
Applicant Total
8
Review Days
56
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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
- K230600
- Device Class
- FDA class 2
- Clearance Type
- Abbreviated
- Regulation Number
- 892.1200
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Spectrum Dynamics Medical, Ltd.
- Date Received
- March 3, 2023
- Decision Date
- April 28, 2023
- 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 |
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Other Clearances by Spectrum Dynamics Medical, Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| 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) | Jan 13, 2026 | Substantially Equivalent |
| K253532 | TruSPECT Processing Station | Dec 30, 2025 | 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 |