The following data is part of a premarket notification filed by Eastman Kodak Company with the FDA for Kodak Digital Science 3600 Distributed Medical Imager, Kodak Digital Science 1200 Distributed Medical Imager, Model 3600.
| Device ID | K983905 |
| 510k Number | K983905 |
| Device Name: | KODAK DIGITAL SCIENCE 3600 DISTRIBUTED MEDICAL IMAGER, KODAK DIGITAL SCIENCE 1200 DISTRIBUTED MEDICAL IMAGER, MODEL 3600 |
| Classification | Camera, Multi Format, Radiological |
| Applicant | EASTMAN KODAK COMPANY 901 ELMGROVE RD. Rochester, NY 14653 -0002 |
| Contact | Judith A Wallace |
| Correspondent | Judith A Wallace EASTMAN KODAK COMPANY 901 ELMGROVE RD. Rochester, NY 14653 -0002 |
| Product Code | LMC |
| CFR Regulation Number | 892.2040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-11-03 |
| Decision Date | 1999-01-25 |
| Summary: | summary |