The following data is part of a premarket notification filed by Universal Pacs, Inc. with the FDA for Unipacs Workstation.
Device ID | K023476 |
510k Number | K023476 |
Device Name: | UNIPACS WORKSTATION |
Classification | System, Image Processing, Radiological |
Applicant | UNIVERSAL PACS, INC. 127 ALBERT HART DR. Baton Rouge, LA 70803 |
Contact | John M Tyler |
Correspondent | John M Tyler UNIVERSAL PACS, INC. 127 ALBERT HART DR. Baton Rouge, LA 70803 |
Product Code | LLZ |
CFR Regulation Number | 892.2050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2002-10-16 |
Decision Date | 2003-01-07 |
Summary: | summary |