The following data is part of a premarket notification filed by Fujifilm Medical Systems U.s.a., Inc. with the FDA for Fuji Ip Cassette Type Pc.
| Device ID | K070920 |
| 510k Number | K070920 |
| Device Name: | FUJI IP CASSETTE TYPE PC |
| Classification | Accelerator, Linear, Medical |
| Applicant | FUJIFILM MEDICAL SYSTEMS U.S.A., INC. 419 WEST AVE. Stamford, CT 06902 -6300 |
| Contact | Debbie Peacock |
| Correspondent | Debbie Peacock FUJIFILM MEDICAL SYSTEMS U.S.A., INC. 419 WEST AVE. Stamford, CT 06902 -6300 |
| Product Code | IYE |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-04-02 |
| Decision Date | 2007-05-22 |
| Summary: | summary |