The following data is part of a premarket notification filed by Fujifilm Medical System U.s.a., Inc. with the FDA for Fcr Dms Optical Disk Image Filing Unit Od-f614, Odf614l & Multimodality System.
| Device ID | K960326 |
| 510k Number | K960326 |
| Device Name: | FCR DMS OPTICAL DISK IMAGE FILING UNIT OD-F614, ODF614L & MULTIMODALITY SYSTEM |
| Classification | Device, Digital Image Storage, Radiological |
| Applicant | FUJIFILM MEDICAL SYSTEM U.S.A., INC. 333 LUDLOW ST. P.O. BOX 120035 Stamford, CT 06912 -0035 |
| Contact | Robert A Uzenoff |
| Correspondent | Robert A Uzenoff FUJIFILM MEDICAL SYSTEM U.S.A., INC. 333 LUDLOW ST. P.O. BOX 120035 Stamford, CT 06912 -0035 |
| Product Code | LMB |
| CFR Regulation Number | 892.2010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-01-24 |
| Decision Date | 1996-03-07 |
| Summary: | summary |