The following data is part of a premarket notification filed by Radialis Inc. with the FDA for Radialis Pet Camera.
| Device ID | K214062 |
| 510k Number | K214062 |
| Device Name: | Radialis PET Camera |
| Classification | System, Tomography, Computed, Emission |
| Applicant | Radialis Inc. Suite 2300B, 290 Munro Street Thunder Bay, CA P7a 7t1 |
| Contact | Michael Waterston |
| Correspondent | Eileen Heller BeanStock Ventures 8885 Rio San Diego Dr. #237 San Diego, CA 92108 |
| Product Code | KPS |
| CFR Regulation Number | 892.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2021-12-27 |
| Decision Date | 2022-02-04 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08500314551332 | K214062 | 000 |
| 00850031455337 | K214062 | 000 |