The following data is part of a premarket notification filed by Fujifilm Medical System U.s.a., Inc. with the FDA for Fuji Speed Suite, Fuji Speed Sute Phase Ii.
| Device ID | K013218 |
| 510k Number | K013218 |
| Device Name: | FUJI SPEED SUITE, FUJI SPEED SUTE PHASE II |
| Classification | Solid State X-ray Imager (flat Panel/digital Imager) |
| Applicant | FUJIFILM MEDICAL SYSTEM U.S.A., INC. 419 WEST AVE. Stamford, CT 06902 |
| Contact | Joseph M Azary |
| Correspondent | Joseph M Azary FUJIFILM MEDICAL SYSTEM U.S.A., INC. 419 WEST AVE. Stamford, CT 06902 |
| Product Code | MQB |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-09-26 |
| Decision Date | 2001-12-20 |
| Summary: | summary |