NovaPACS

System, Image Processing, Radiological

Novarad Corporation

The following data is part of a premarket notification filed by Novarad Corporation with the FDA for Novapacs.

Pre-market Notification Details

• 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

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
B109NOVAPACS8690	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
B109NOVAPACS81070	K171754	000
B109NOVAPACS9130	K171754	000
B109NOVAPACS9140	K171754	000
B109NOVAPACS8770	K171754	000
B109NOVAPACS8760	K171754	000
B109NOVAPACS8740	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
B109NOVAPACS85180	K171754	000
B109NOVAPACS9150	K171754	000