The following data is part of a premarket notification filed by Icon Medical Systems, Inc. with the FDA for Icon Teleradiology System.
| Device ID | K911752 |
| 510k Number | K911752 |
| Device Name: | ICON TELERADIOLOGY SYSTEM |
| Classification | System, Image Processing, Radiological |
| Applicant | ICON MEDICAL SYSTEMS, INC. 1 BAYIEW SUITE 5 Los Gatos, CA 95030 |
| Contact | William E.mckay |
| Correspondent | William E.mckay ICON MEDICAL SYSTEMS, INC. 1 BAYIEW SUITE 5 Los Gatos, CA 95030 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-04-18 |
| Decision Date | 1991-07-31 |