The following data is part of a premarket notification filed by Eastman Kodak Company with the FDA for Kodak Directview Cr 800 System, Catalog# 1268622; Kodak Directview Cr 900 System, Catalog# 1170976.
| Device ID | K020635 |
| 510k Number | K020635 |
| Device Name: | KODAK DIRECTVIEW CR 800 SYSTEM, CATALOG# 1268622; KODAK DIRECTVIEW CR 900 SYSTEM, CATALOG# 1170976 |
| Classification | Solid State X-ray Imager (flat Panel/digital Imager) |
| Applicant | EASTMAN KODAK COMPANY 343 STATE ST. Rochester, NY 14650 |
| Contact | Susan Pate |
| Correspondent | Susan Pate EASTMAN KODAK COMPANY 343 STATE ST. Rochester, NY 14650 |
| Product Code | MQB |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-02-27 |
| Decision Date | 2002-03-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 60889978981311 | K020635 | 000 |
| 60889978113613 | K020635 | 000 |
| 60889971794550 | K020635 | 000 |
| 60889971056504 | K020635 | 000 |