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FDA 510(k)

RadGil2

K-Number: K201177 · 2020-08-17

ApplicantR3 X-Ray L.L.C
Decision Date2020-08-17
Product CodeMOT
DecisionSubstantially Equivalent

Device Summary

RadGil2 is the device name listed in this FDA 510(k) record. The listed applicant is R3 X-Ray L.L.C. It received FDA 510(k) clearance on 2020-08-17 under 510(k) 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. The listed applicant is R3 X-Ray L.L.C. The 510(k) number is K201177.

When did RadGil2 receive FDA 510(k) clearance?

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

Who is the listed applicant for RadGil2?

The FDA 510(k) record lists R3 X-Ray L.L.C as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RadGil2?

The FDA product code for RadGil2 is MOT.

Related Devices (Code: MOT)

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.

K181737Raycell MK1Best Theratronics LimitedK172087SANGRAYHitachi , Ltd.K161324Raycell Mk2Best Theratronics Limited

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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