The following data is part of a premarket notification filed by Eastman Kodak Company with the FDA for Kodak Digital Sciences (kds) Image View.
Device ID | K981053 |
510k Number | K981053 |
Device Name: | KODAK DIGITAL SCIENCES (KDS) IMAGE VIEW |
Classification | System, Digital Image Communications, Radiological |
Applicant | EASTMAN KODAK COMPANY 18325 WATERVIEW PKWY. Dallas, TX 75252 -8026 |
Contact | Robert Wolfarth |
Correspondent | Robert Wolfarth EASTMAN KODAK COMPANY 18325 WATERVIEW PKWY. Dallas, TX 75252 -8026 |
Product Code | LMD |
CFR Regulation Number | 892.2020 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1998-03-23 |
Decision Date | 1998-06-18 |
Summary: | summary |