BBX-PET Scanner— 510(k) K210450
Substantially EquivalentPrescient Imaging, LLC
FDA 510(k) clearance K210450 for BBX-PET Scanner, Substantially Equivalent on 2021-03-17. Applicant: Prescient Imaging, LLC. Device class: 2.
Clearance details
- Applicant
- Prescient Imaging, LLC
- 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
- Hawthorne, CA, US
Recent devices under product code KPS
view allData sourced from openFDA. This site is unofficial and independent of the FDA.