Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

RadGil2

K-Number: K201177 · 2020-08-17

Decision Date2020-08-17
Product CodeMOT
DecisionSubstantially Equivalent

Device Summary

RadGil2 is a medical device manufactured by R3 X-Ray L.L.C. It received FDA 510(k) clearance on 2020-08-17 under approval number K201177. The device is classified under product code MOT. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RadGil2?

RadGil2 is a medical device that received FDA 510(k) clearance on 2020-08-17. It is manufactured by R3 X-Ray L.L.C. The 510(k) number is K201177.

When was RadGil2 approved by the FDA?

RadGil2 received FDA 510(k) clearance on 2020-08-17, under approval number K201177.

What company makes RadGil2?

RadGil2 is manufactured by R3 X-Ray L.L.C.

What is the FDA product code for RadGil2?

The FDA product code for RadGil2 is MOT.

Related Devices (Code: MOT)

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.