The following data is part of a premarket notification filed by Novarad Corporation with the FDA for Novapacs.
Device ID | K171754 |
510k Number | K171754 |
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 | 2017-06-13 |
Decision Date | 2017-07-28 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
B109NOVAPACS8690 | K171754 | 000 |
B109NOVAPACS8760 | K171754 | 000 |
B109NOVAPACS8770 | K171754 | 000 |
B109NOVAPACS87110 | K171754 | 000 |
B109NOVAPACS8830 | K171754 | 000 |
B109NOVAPACS8840 | K171754 | 000 |
B109NOVAPACS8850 | K171754 | 000 |
B109NOVAPACS8910 | K171754 | 000 |
B109NOVAPACS8920 | K171754 | 000 |
B109NOVAPACS8930 | K171754 | 000 |
B109NOVAPACS81030 | K171754 | 000 |
B109NOVAPACS8780 | K171754 | 000 |
B109NOVAPACS8740 | K171754 | 000 |
B109NOVAPACS85180 | K171754 | 000 |
B109NOVAPACS8680 | K171754 | 000 |
B109NOVAPACS8670 | K171754 | 000 |
B109NOVAPACS8660 | K171754 | 000 |
B109NOVAPACS8650 | K171754 | 000 |
B109NOVAPACS8640 | K171754 | 000 |
B109NOVAPACS8630 | K171754 | 000 |
B109NOVAPACS86140 | K171754 | 000 |
B109NOVAPACS86120 | K171754 | 000 |
B109NOVAPACS86110 | K171754 | 000 |
B109NOVAPACS8610 | K171754 | 000 |
B109NOVAPACS85190 | K171754 | 000 |
B109NOVAPACS81070 | K171754 | 000 |
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 |