510(k) K214062
K214062 is an FDA 510(k) premarket notification submitted by Radialis, Inc. for the device "Radialis PET Camera". The FDA issued a decision of Substantially Equivalent on Feb 4, 2022. The device falls under product code KPS (System, Tomography, Computed, Emission), a Class II device regulated under 21 CFR 892.1200.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Feb 4, 2022
- Date Received
- Dec 27, 2021
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- System, Tomography, Computed, Emission
- Device Class
- Class II
- Regulation Number
- 892.1200
- Review Panel
- RA
- Submission Type
- 510(k)