K212587 is an FDA 510(k) clearance for the 3D-RD-S. This device is classified as a Camera, Scintillation (gamma) (Class I - General Controls, product code IYX).
Submitted by Radiopharmaceutical Imaging and Dosimetry, LLC (Baltimore, US). The FDA issued a Cleared decision on February 22, 2023, 555 days after receiving the submission on August 16, 2021.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1100.
| 510(k) Number | K212587 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 16, 2021 |
| Decision Date | February 22, 2023 |
| Days to Decision | 555 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | IYX - Camera, Scintillation (gamma) |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 892.1100 |