The following data is part of a premarket notification filed by Samsung Sds Co., Ltd with the FDA for Samsung Raypax Film Digitizer.
| Device ID | K992112 |
| 510k Number | K992112 |
| Device Name: | SAMSUNG RAYPAX FILM DIGITIZER |
| Classification | System, Image Processing, Radiological |
| Applicant | SAMSUNG SDS CO., LTD 2001 EAST OAKSHORES DR. Aubrey, TX 76227 |
| Contact | Carl Alletto |
| Correspondent | Carl Alletto SAMSUNG SDS CO., LTD 2001 EAST OAKSHORES DR. Aubrey, TX 76227 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-06-22 |
| Decision Date | 1999-09-09 |
| Summary: | summary |