The following data is part of a premarket notification filed by Controlrad, Inc. with the FDA for Controlrad Trace Model 8.
| Device ID | K183109 |
| 510k Number | K183109 |
| Device Name: | ControlRad Trace Model 8 |
| Classification | Interventional Fluoroscopic X-ray System |
| Applicant | ControlRad, Inc. 150 N. Radnor Chester Road, Suite F-200 Radnor, PA 19087 |
| Contact | Guillaume Bailliard |
| Correspondent | Sasha Gelfand ControlRad Ltd. 20 HaTaas St. Kfar Saba, IL 4442520 |
| 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 | 2018-11-08 |
| Decision Date | 2019-05-13 |
| Summary: | summary |