The following data is part of a premarket notification filed by C4 Imaging Llc with the FDA for Hdr Mri Lumen Marker.
| Device ID | K180069 |
| 510k Number | K180069 |
| Device Name: | HDR MRI Lumen Marker |
| Classification | System, Applicator, Radionuclide, Remote-controlled |
| Applicant | C4 Imaging LLC 196 West Ashland Street Doylestown, PA 18901 |
| Contact | Andrew Bright |
| Correspondent | Andrew Bright C4 Imaging LLC 196 West Ashland Street Doylestown, PA 18901 |
| Product Code | JAQ |
| CFR Regulation Number | 892.5700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-01-09 |
| Decision Date | 2018-04-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00863593000235 | K180069 | 000 |