510(k) K210450
K210450 is an FDA 510(k) premarket notification submitted by Prescient Imaging, LLC for the device "BBX-PET Scanner". The FDA issued a decision of Substantially Equivalent on Mar 17, 2021. 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
- Mar 17, 2021
- Date Received
- Feb 16, 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)