The following data is part of a premarket notification filed by Kodak Health Imaging Systems, Inc. with the FDA for Kodak Digital Science(kds) Medical Image And Information Library.
| Device ID | K960981 |
| 510k Number | K960981 |
| Device Name: | KODAK DIGITAL SCIENCE(KDS) MEDICAL IMAGE AND INFORMATION LIBRARY |
| Classification | Device, Digital Image Storage, Radiological |
| Applicant | KODAK HEALTH IMAGING SYSTEMS, INC. 18325 WATERVIEW PKWY. Dallas, TX 75252 |
| Contact | Stan E Tillman |
| Correspondent | Stan E Tillman KODAK HEALTH IMAGING SYSTEMS, INC. 18325 WATERVIEW PKWY. Dallas, TX 75252 |
| Product Code | LMB |
| CFR Regulation Number | 892.2010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-03-11 |
| Decision Date | 1996-06-07 |
| Summary: | summary |