The following data is part of a premarket notification filed by Eastman Kodak Company with the FDA for Kodak Digital Science (kds) Medical Image And Information Library (miil).
| Device ID | K972380 |
| 510k Number | K972380 |
| Device Name: | KODAK DIGITAL SCIENCE (KDS) MEDICAL IMAGE AND INFORMATION LIBRARY (MIIL) |
| Classification | Device, Digital Image Storage, Radiological |
| Applicant | EASTMAN KODAK COMPANY 18325 WATERVIEW PKWY. Dallas, TX 75252 |
| Contact | Nancy Butcher |
| Correspondent | Nancy Butcher EASTMAN KODAK COMPANY 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 | 1997-06-26 |
| Decision Date | 1997-09-11 |
| Summary: | summary |