The following data is part of a premarket notification filed by Eastman Kodak Company with the FDA for Kodak Digital Science Oncology Image Manager.
Device ID | K980118 |
510k Number | K980118 |
Device Name: | KODAK DIGITAL SCIENCE ONCOLOGY IMAGE MANAGER |
Classification | System, Image Processing, Radiological |
Applicant | EASTMAN KODAK COMPANY 18325 WATERVIEW PKWY. Dallas, TX 75252 -8026 |
Contact | Nancy Butcher |
Correspondent | Nancy Butcher EASTMAN KODAK COMPANY 18325 WATERVIEW PKWY. Dallas, TX 75252 -8026 |
Product Code | LLZ |
CFR Regulation Number | 892.2050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1998-01-13 |
Decision Date | 1998-03-17 |
Summary: | summary |