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 |