VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364); VERITON CT 400 Series Digital SPECT/CT System (VERITON CT 416/464)
FDA 510(k) clearance K230600 · decided 2023-04-28
Clearance details
- K-number
- K230600
- 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)
- Applicant
- Spectrum Dynamics Medical, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2023-03-03
- Decision date
- 2023-04-28
- Days to decision
- 56 days
- Clearance type
- Abbreviated
- Product code
- KPS
- Device class
- 2
- Regulation number
- 892.1200
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Caesarea, IL
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.