The following data is part of a premarket notification filed by C4 Imaging Llc with the FDA for Mri Marker.
| Device ID | K131689 |
| 510k Number | K131689 |
| Device Name: | MRI MARKER |
| Classification | Source, Brachytherapy, Radionuclide |
| Applicant | C4 IMAGING LLC 2550 SOUTH TELEGRAPH ROAD SUITE 108 Bloomfield Hills, MI 48302 |
| Contact | Stephen J Goldner, Jd, Rac |
| Correspondent | Stephen J Goldner, Jd, Rac C4 IMAGING LLC 2550 SOUTH TELEGRAPH ROAD SUITE 108 Bloomfield Hills, MI 48302 |
| Product Code | KXK |
| CFR Regulation Number | 892.5730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-06-10 |
| Decision Date | 2013-11-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00863593000211 | K131689 | 000 |
| 00863593000204 | K131689 | 000 |