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FDA 510(k)

NovaPACS

K-Number: K160371 · 2016-10-14

ApplicantNovarad Corporation
Decision Date2016-10-14
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

NovaPACS is a medical device manufactured by Novarad Corporation. It received FDA 510(k) clearance on 2016-10-14 under approval 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. It is manufactured by Novarad Corporation. The 510(k) number is K160371.

When was NovaPACS approved by the FDA?

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

What company makes NovaPACS?

NovaPACS is manufactured by Novarad Corporation.

What is the FDA product code for NovaPACS?

The FDA product code for NovaPACS is LLZ.

Other Devices by Novarad Corporation

K171754NovaPACS K172418OpenSight K220146VisAR

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Official Source

View on FDA Database →

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

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