The following data is part of a premarket notification filed by Fujifilm Medical System U.s.a., Inc. with the FDA for Fuji Computed Radiography (fcr) Velocity Image Reader.
| Device ID | K033561 |
| 510k Number | K033561 |
| Device Name: | FUJI COMPUTED RADIOGRAPHY (FCR) VELOCITY IMAGE READER |
| 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 | Frank Gianelli |
| Correspondent | Susan Gill UNDERWRITERS LABORATORIES, INC. 12 LABORATORY DR. Research Triangle, NC 27709 |
| Product Code | MQB |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2003-11-12 |
| Decision Date | 2003-11-26 |
| Summary: | summary |