The following data is part of a premarket notification filed by Novarad Corporation with the FDA for Novapacs.
| Device ID | K160371 |
| 510k Number | K160371 |
| Device Name: | NovaPACS |
| Classification | System, Image Processing, Radiological |
| Applicant | NOVARAD CORPORATION 752 EAST 1180 SOUTH #200 American Fork, UT 84003 |
| Contact | Doug Merrill |
| Correspondent | Doug Merrill NOVARAD CORPORATION 752 EAST 1180 SOUTH #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 | 2016-02-10 |
| Decision Date | 2016-10-14 |
| 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 |