CLARITY PET
FDA 510(k) clearance K032866 · decided 2003-12-12
Clearance details
- K-number
- K032866
- Device name
- CLARITY PET
- Applicant
- Shared P.E.T. Imaging, LLC
- Decision
- Substantially Equivalent
- Date received
- 2003-09-15
- Decision date
- 2003-12-12
- Days to decision
- 88 days
- Clearance type
- Traditional
- Product code
- KPS
- Device class
- 2
- Regulation number
- 892.1200
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Washington, DC, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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Recalls involving this device
No recalls on record reference this clearance.