The following data is part of a premarket notification filed by Olicon Imaging Systems, Inc. with the FDA for Olicon Imaging Systems, Inc. Gateway And/or Software.
| Device ID | K973793 |
| 510k Number | K973793 |
| Device Name: | OLICON IMAGING SYSTEMS, INC. GATEWAY AND/OR SOFTWARE |
| Classification | System, Digital Image Communications, Radiological |
| Applicant | OLICON IMAGING SYSTEMS, INC. 6741 GRANT AVE. Plano, TX 75024 |
| Contact | Herman Oosterwijck |
| Correspondent | Herman Oosterwijck OLICON IMAGING SYSTEMS, INC. 6741 GRANT AVE. Plano, TX 75024 |
| Product Code | LMD |
| CFR Regulation Number | 892.2020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-10-06 |
| Decision Date | 1997-12-17 |
| Summary: | summary |