The following data is part of a premarket notification filed by Kodak Health Imaging Systems, Inc. with the FDA for Kodak Digital Science Film Digitizer L7501/l7506 (with Film Autofeeder).
| Device ID | K961768 |
| 510k Number | K961768 |
| Device Name: | KODAK DIGITAL SCIENCE FILM DIGITIZER L7501/L7506 (WITH FILM AUTOFEEDER) |
| Classification | Digitizer, Image, Radiological |
| Applicant | KODAK HEALTH IMAGING SYSTEMS, INC. 18325 WATERVIEW PKWY. Dallas, TX 75252 |
| Contact | Edward A Weaver |
| Correspondent | Edward A Weaver KODAK HEALTH IMAGING SYSTEMS, INC. 18325 WATERVIEW PKWY. Dallas, TX 75252 |
| Product Code | LMA |
| CFR Regulation Number | 892.2030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-05-08 |
| Decision Date | 1996-08-22 |
| Summary: | summary |