The following data is part of a premarket notification filed by Prescient Imaging, Llc with the FDA for Bbx-pet Scanner.
| Device ID | K210450 |
| 510k Number | K210450 |
| Device Name: | BBX-PET Scanner |
| Classification | System, Tomography, Computed, Emission |
| Applicant | Prescient Imaging, LLC 12569 Crenshaw Blvd Hawthorne, CA 90250 |
| Contact | Farhad Daghighian |
| Correspondent | Dave Yungvirt THIRD PARTY REVIEW GROUP, LLC 25 Independence Blvd Warren, NJ 07059 |
| Product Code | KPS |
| CFR Regulation Number | 892.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2021-02-16 |
| Decision Date | 2021-03-17 |