FDA 510(k)

Galaxy R Digital Radiography Upgrade

K-Number: K172435 · 2017-10-13

Decision Date2017-10-13

Product CodeMQB

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

Galaxy R Digital Radiography Upgrade is a medical device manufactured by Medien International Co, Ltd.. It received FDA 510(k) clearance on 2017-10-13 under approval number K172435. The device is classified under product code MQB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Galaxy R Digital Radiography Upgrade?

Galaxy R Digital Radiography Upgrade is a medical device that received FDA 510(k) clearance on 2017-10-13. It is manufactured by Medien International Co, Ltd.. The 510(k) number is K172435.

When was Galaxy R Digital Radiography Upgrade approved by the FDA?

Galaxy R Digital Radiography Upgrade received FDA 510(k) clearance on 2017-10-13, under approval number K172435.

What company makes Galaxy R Digital Radiography Upgrade?

Galaxy R Digital Radiography Upgrade is manufactured by Medien International Co, Ltd..

What is the FDA product code for Galaxy R Digital Radiography Upgrade?

The FDA product code for Galaxy R Digital Radiography Upgrade is MQB.

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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.