The following data is part of a premarket notification filed by C4 Imaging Llc with the FDA for C4 Fiducial Marker.
| Device ID | K192771 |
| 510k Number | K192771 |
| Device Name: | C4 Fiducial Marker |
| Classification | Marker, Radiographic, Implantable |
| 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 | NEU |
| CFR Regulation Number | 878.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-09-30 |
| Decision Date | 2020-10-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00863593000259 | K192771 | 000 |
| 00863593000242 | K192771 | 000 |
| 00863593000273 | K192771 | 000 |