The following data is part of a premarket notification filed by Eastman Kodak Company with the FDA for Kodak Digital Science Cardiac Viewer.
Device ID | K974086 |
510k Number | K974086 |
Device Name: | KODAK DIGITAL SCIENCE CARDIAC VIEWER |
Classification | System, Image Processing, Radiological |
Applicant | EASTMAN KODAK COMPANY 901 ELMGROVE RD. Rochester, NY 14653 -0002 |
Contact | Mark Smith |
Correspondent | Mark Smith EASTMAN KODAK COMPANY 901 ELMGROVE RD. Rochester, NY 14653 -0002 |
Product Code | LLZ |
CFR Regulation Number | 892.2050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1997-10-29 |
Decision Date | 1998-01-20 |