The following data is part of a premarket notification filed by Radkor, Inc. with the FDA for Radkor Ts10-b.
| Device ID | K892196 |
| 510k Number | K892196 |
| Device Name: | RADKOR TS10-B |
| Classification | Table, Radiographic, Stationary Top |
| Applicant | RADKOR, INC. 16610 ASTON ST. Irvine, CA 92714 |
| Contact | Frank A.buzyn |
| Correspondent | Frank A.buzyn RADKOR, INC. 16610 ASTON ST. Irvine, CA 92714 |
| Product Code | IXQ |
| CFR Regulation Number | 892.1980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-04-03 |
| Decision Date | 1989-04-26 |