The following data is part of a premarket notification filed by Agfa-gevaert, Inc. with the FDA for Scopix Video Imager.
| Device ID | K882096 |
| 510k Number | K882096 |
| Device Name: | SCOPIX VIDEO IMAGER |
| Classification | Camera, Multi Format, Radiological |
| Applicant | AGFA-GEVAERT, INC. 100 CHALLENGER RD. Ridgefield Park, NJ 07660 |
| Contact | William J Reddy |
| Correspondent | William J Reddy AGFA-GEVAERT, INC. 100 CHALLENGER RD. Ridgefield Park, NJ 07660 |
| Product Code | LMC |
| CFR Regulation Number | 892.2040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-05-18 |
| Decision Date | 1988-08-09 |