The following data is part of a premarket notification filed by Samsung Sds Co., Ltd with the FDA for Raypax Web Clinical System.
Device ID | K992426 |
510k Number | K992426 |
Device Name: | RAYPAX WEB CLINICAL SYSTEM |
Classification | System, Digital Image Communications, 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 | LMD |
CFR Regulation Number | 892.2020 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1999-07-21 |
Decision Date | 1999-10-13 |
Summary: | summary |