VERITON CT whole body SPECT/CT system— 510(k) K190457
Substantially EquivalentSpectrum Dynamics Medical, Ltd.
FDA 510(k) clearance K190457 for VERITON CT whole body SPECT/CT system, Substantially Equivalent on 2019-07-12. Applicant: Spectrum Dynamics Medical, Ltd.. Device class: 2.
Clearance details
- Applicant
- Spectrum Dynamics Medical, Ltd.
- Product code
- Code KPS
- Device class
- Class 2
- Regulation
- 21 CFR 892.1200
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Caesarea, IL
Recent devices under product code KPS
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