The following data is part of a premarket notification filed by Eastman Kodak Company with the FDA for Kodak Directview Pacs/image Management System, Kodak Directview Workflow Manager,kodak Directview Cx/dx, Kodak Directvib.
| Device ID | K030781 |
| 510k Number | K030781 |
| Device Name: | KODAK DIRECTVIEW PACS/IMAGE MANAGEMENT SYSTEM, KODAK DIRECTVIEW WORKFLOW MANAGER,KODAK DIRECTVIEW CX/DX, KODAK DIRECTVIB |
| Classification | System, Image Processing, Radiological |
| Applicant | EASTMAN KODAK COMPANY 47315 MISSION FALLS CT Fremont, CA 94539 |
| Contact | Linda J Moore |
| Correspondent | Linda J Moore EASTMAN KODAK COMPANY 47315 MISSION FALLS CT Fremont, CA 94539 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-03-11 |
| Decision Date | 2003-05-29 |
| Summary: | summary |