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 |