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 |