The following data is part of a premarket notification filed by Fujifilm Medical System U.s.a., Inc. with the FDA for Fuji Medical Laser Imager Fl-im D.
| Device ID | K945475 |
| 510k Number | K945475 |
| Device Name: | FUJI MEDICAL LASER IMAGER FL-IM D |
| Classification | Camera, Multi Format, 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 | LMC |
| CFR Regulation Number | 892.2040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-11-08 |
| Decision Date | 1995-03-09 |