The following data is part of a premarket notification filed by Novarad Corp. with the FDA for Novapacs.
Device ID | K132853 |
510k Number | K132853 |
Device Name: | NOVAPACS |
Classification | System, Image Processing, Radiological |
Applicant | NOVARAD CORP. 752 E 1180 S Ste 200 American Fork, UT 84003 |
Contact | Amy Hoffman |
Correspondent | Doug Merrill NOVARAD CORP. 752 E 1180 S Ste 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 | 2013-09-12 |
Decision Date | 2014-10-30 |
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 |