The following data is part of a premarket notification filed by Eastman Kodak Company with the FDA for Kodak Directview Tabletop Cassette.
| Device ID | K013686 |
| 510k Number | K013686 |
| Device Name: | KODAK DIRECTVIEW TABLETOP CASSETTE |
| Classification | Cassette, Radiographic Film |
| Applicant | EASTMAN KODAK COMPANY 1669 LAKE AVE. Rochester, NY 14652 |
| Contact | Judith A Wallace |
| Correspondent | Judith A Wallace EASTMAN KODAK COMPANY 1669 LAKE AVE. Rochester, NY 14652 |
| Product Code | IXA |
| CFR Regulation Number | 892.1850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-11-07 |
| Decision Date | 2001-12-07 |
| Summary: | summary |