The following data is part of a premarket notification filed by Diacor, Inc. with the FDA for Radassist.
| Device ID | K934566 |
| 510k Number | K934566 |
| Device Name: | RADASSIST |
| Classification | Accelerator, Linear, Medical |
| Applicant | DIACOR, INC. 3191 SOUTH 3300 EAST, SUITE 100-A Salt Lake City, UT 84109 |
| Contact | Glenn N Waterman |
| Correspondent | Glenn N Waterman DIACOR, INC. 3191 SOUTH 3300 EAST, SUITE 100-A Salt Lake City, UT 84109 |
| Product Code | IYE |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-09-21 |
| Decision Date | 1993-11-03 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() RADASSIST 85345750 4418997 Live/Registered |
Lucid Radiology Solutions, LLC 2011-06-14 |
![]() RADASSIST 74440315 1841763 Dead/Cancelled |
Diacor, Inc. 1993-09-27 |