The following data is part of a premarket notification filed by Olicon Imaging Systems, Inc. with the FDA for Raytel Digital Imaging Systems.
| Device ID | K922164 |
| 510k Number | K922164 |
| Device Name: | RAYTEL DIGITAL IMAGING SYSTEMS |
| Classification | System, Digital Image Communications, Radiological |
| Applicant | OLICON IMAGING SYSTEMS, INC. 1011 CALLE AMANECER San Clemente, CA 92673 |
| Contact | R. L Paulsen |
| Correspondent | R. L Paulsen OLICON IMAGING SYSTEMS, INC. 1011 CALLE AMANECER San Clemente, CA 92673 |
| Product Code | LMD |
| CFR Regulation Number | 892.2020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-05-08 |
| Decision Date | 1993-01-21 |