The following data is part of a premarket notification filed by Kodak Health Imaging Systems, Inc. with the FDA for Kodak Digital Science Medical Modality Acquisition Unit.
| Device ID | K961739 |
| 510k Number | K961739 |
| Device Name: | KODAK DIGITAL SCIENCE MEDICAL MODALITY ACQUISITION UNIT |
| Classification | System, Image Processing, Radiological |
| Applicant | KODAK HEALTH IMAGING SYSTEMS, INC. 18325 WATERVIEW PKWY. Dallas, TX 75252 |
| Contact | Nancy Butcher |
| Correspondent | Nancy Butcher KODAK HEALTH IMAGING SYSTEMS, INC. 18325 WATERVIEW PKWY. Dallas, TX 75252 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-05-03 |
| Decision Date | 1996-11-14 |
| Summary: | summary |