The following data is part of a premarket notification filed by Samsung Sds Co., Ltd with the FDA for Samsung Raypax System.
| Device ID | K991537 |
| 510k Number | K991537 |
| Device Name: | SAMSUNG RAYPAX SYSTEM |
| Classification | System, Digital Image Communications, Radiological |
| Applicant | SAMSUNG SDS CO., LTD 2001 EAST OAKSHORES DR. Aubrey, TX 76227 |
| Contact | Herman Oosterwjick |
| Correspondent | Herman Oosterwjick SAMSUNG SDS CO., LTD 2001 EAST OAKSHORES DR. Aubrey, TX 76227 |
| Product Code | LMD |
| CFR Regulation Number | 892.2020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-05-03 |
| Decision Date | 1999-07-06 |
| Summary: | summary |