The following data is part of a premarket notification filed by Controlrad, Inc. with the FDA for Controlrad Trace Model 9.
| Device ID | K200663 |
| 510k Number | K200663 |
| Device Name: | ControlRad Trace Model 9 |
| Classification | Interventional Fluoroscopic X-ray System |
| Applicant | ControlRad, Inc. 275 Scientific Drive NW #1100 Norcross, GA 30092 |
| Contact | Chris Fair |
| Correspondent | Linda Braddon Secure BioMed Evaluations 7828 Hickory Flat Highway, Suite 120 Woodstock, GA 30188 |
| Product Code | OWB |
| Subsequent Product Code | JAA |
| Subsequent Product Code | OXO |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-03-13 |
| Decision Date | 2020-06-24 |