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FDA 510(k)

Galaxy R Digital Radiography Upgrade

K-Number: K172435 · 2017-10-13

ApplicantMedien International Co, Ltd.
Decision Date2017-10-13
Product CodeMQB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Galaxy R Digital Radiography Upgrade is the device name listed in this FDA 510(k) record. The listed applicant is Medien International Co, Ltd.. It received FDA 510(k) clearance on 2017-10-13 under 510(k) 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. The listed applicant is Medien International Co, Ltd.. The 510(k) number is K172435.

When did Galaxy R Digital Radiography Upgrade receive FDA 510(k) clearance?

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

Who is the listed applicant for Galaxy R Digital Radiography Upgrade?

The FDA 510(k) record lists Medien International Co, Ltd. as the applicant. This does not by itself establish the device manufacturer.

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

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

Related Devices (Code: MQB)

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.

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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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