The following data is part of a premarket notification filed by C4 Imaging, Llc with the FDA for Sirius Mri Marker Ns.
| Device ID | K171487 |
| 510k Number | K171487 |
| Device Name: | Sirius MRI Marker NS |
| Classification | Source, Brachytherapy, Radionuclide |
| Applicant | C4 Imaging, LLC 196 West Ashland Street Doylestown, PA 18901 |
| Contact | Andrew Bright |
| Correspondent | Stephen J. Goldner Regulatory Affairs Associates 4761 Tara Court West Bloomfield, MI 48323 |
| Product Code | KXK |
| CFR Regulation Number | 892.5730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-05-22 |
| Decision Date | 2017-08-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00863593000228 | K171487 | 000 |