The following data is part of a premarket notification filed by Samsung Sds Co., Ltd with the FDA for Samsung Raypax Long Term Archive.
| Device ID | K992131 |
| 510k Number | K992131 |
| Device Name: | SAMSUNG RAYPAX LONG TERM ARCHIVE |
| Classification | Device, Digital Image Storage, 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 | LMB |
| CFR Regulation Number | 892.2010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-06-23 |
| Decision Date | 1999-09-13 |
| Summary: | summary |