The following data is part of a premarket notification filed by Adac Laboratories with the FDA for Omniview Digital Radiology Imaging System.
| Device ID | K901118 |
| 510k Number | K901118 |
| Device Name: | OMNIVIEW DIGITAL RADIOLOGY IMAGING SYSTEM |
| Classification | Device, Digital Image Storage, Radiological |
| Applicant | ADAC LABORATORIES 540 ALDER DR. Milpitas, CA 95035 |
| Contact | Larry Hernandez |
| Correspondent | Larry Hernandez ADAC LABORATORIES 540 ALDER DR. Milpitas, CA 95035 |
| Product Code | LMB |
| CFR Regulation Number | 892.2010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-03-12 |
| Decision Date | 1990-04-10 |