OpenSight
K-Number: K172418 · 2018-09-21
ApplicantNovarad Corporation
Decision Date2018-09-21
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
OpenSight is a medical device manufactured by Novarad Corporation. It received FDA 510(k) clearance on 2018-09-21 under approval number K172418. 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 OpenSight?
OpenSight is a medical device that received FDA 510(k) clearance on 2018-09-21. It is manufactured by Novarad Corporation. The 510(k) number is K172418.
When was OpenSight approved by the FDA?
OpenSight received FDA 510(k) clearance on 2018-09-21, under approval number K172418.
What company makes OpenSight?
OpenSight is manufactured by Novarad Corporation.
What is the FDA product code for OpenSight?
The FDA product code for OpenSight is LLZ.
Other Devices by Novarad Corporation
Related Devices (Code: LLZ)
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.