Radialis PET Camera— 510(k) K214062
Substantially EquivalentRadialis, Inc.
FDA 510(k) clearance K214062 for Radialis PET Camera, Substantially Equivalent on 2022-02-04. Applicant: Radialis, Inc.. Device class: 2.
Clearance details
- Applicant
- Radialis, Inc.
- 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
- Thunder Bay, CA
Recent devices under product code KPS
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