The following data is part of a premarket notification filed by Isoray Medical, Inc. with the FDA for Sirius Mri Markers, Cs-131 Preloaded Strands With Sirius Mri Markers In 18 Gauge Needles.
| Device ID | K202267 |
| 510k Number | K202267 |
| Device Name: | Sirius MRI Markers, Cs-131 Preloaded Strands With Sirius MRI Markers In 18 Gauge Needles |
| Classification | Source, Brachytherapy, Radionuclide |
| Applicant | Isoray Medical, Inc. 350 Hills St, Suite 106 Richland, WA 99354 |
| Contact | Leslie White |
| Correspondent | Grace Powers Grace Powers - Powers Regulatory Consulting 2451 Cumberland Parkway SE, Suite 3740 Atlanta, GA 30080 |
| Product Code | KXK |
| CFR Regulation Number | 892.5730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-08-11 |
| Decision Date | 2020-12-31 |