The following data is part of a premarket notification filed by Medical Standard Co., Ltd. with the FDA for Pacsplus.
Device ID | K023460 |
510k Number | K023460 |
Device Name: | PACSPLUS |
Classification | System, Image Processing, Radiological |
Applicant | MEDICAL STANDARD CO., LTD. 1100 LAKEVIEW BLVD. Denton, TX 76201 |
Contact | Carl Alletto |
Correspondent | Carl Alletto MEDICAL STANDARD CO., LTD. 1100 LAKEVIEW BLVD. Denton, TX 76201 |
Product Code | LLZ |
CFR Regulation Number | 892.2050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2002-10-15 |
Decision Date | 2003-01-09 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
PACSPLUS 77324370 3693259 Dead/Cancelled |
Medical Standard Co., Ltd. 2007-11-08 |