FDA 510(k)

NovaPACS

K-Number: K160371 · 2016-10-14

Decision Date2016-10-14

Product CodeLLZ

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

NovaPACS is the device name listed in this FDA 510(k) record. The listed applicant is Novarad Corporation. It received FDA 510(k) clearance on 2016-10-14 under 510(k) number K160371. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NovaPACS?

NovaPACS is a medical device that received FDA 510(k) clearance on 2016-10-14. The listed applicant is Novarad Corporation. The 510(k) number is K160371.

When did NovaPACS receive FDA 510(k) clearance?

NovaPACS received FDA 510(k) clearance on 2016-10-14, under 510(k) number K160371.

Who is the listed applicant for NovaPACS?

The FDA 510(k) record lists Novarad Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NovaPACS?

The FDA product code for NovaPACS is LLZ.

Other records listing Novarad Corporation as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K220146VisAR K172418OpenSight K171754NovaPACS

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.