The following data is part of a premarket notification filed by Novarad Corp. with the FDA for Novapacs.
Device ID | K063153 |
510k Number | K063153 |
Device Name: | NOVAPACS |
Classification | System, Image Processing, Radiological |
Applicant | NOVARAD CORP. 758 EAST UTAH VALLEY DR. SUITE 200 American Fork, UT 84003 |
Contact | Paul Shumway |
Correspondent | Paul Shumway NOVARAD CORP. 758 EAST UTAH VALLEY DR. SUITE 200 American Fork, UT 84003 |
Product Code | LLZ |
CFR Regulation Number | 892.2050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2006-10-16 |
Decision Date | 2006-12-07 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
NOVAPACS 77004504 3390641 Live/Registered |
NovaRad Corporation 2006-09-21 |
NOVAPACS 76511039 not registered Dead/Abandoned |
Novarad Corporation 2003-05-01 |