The following data is part of a premarket notification filed by Eastman Kodak Company with the FDA for Kodak Digital Science Medical Image Manager.
Device ID | K960382 |
510k Number | K960382 |
Device Name: | KODAK DIGITAL SCIENCE MEDICAL IMAGE MANAGER |
Classification | System, Digital Image Communications, 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 | LMD |
CFR Regulation Number | 892.2020 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-01-25 |
Decision Date | 1996-04-17 |
Summary: | summary |