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FDA 510(k)

RADMAX Digital Imaging Software

K-Number: K182537 · 2019-03-08

ApplicantDRGEM Corporation
Decision Date2019-03-08
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

RADMAX Digital Imaging Software is the device name listed in this FDA 510(k) record. The listed applicant is DRGEM Corporation. It received FDA 510(k) clearance on 2019-03-08 under 510(k) number K182537. 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 RADMAX Digital Imaging Software?

RADMAX Digital Imaging Software is a medical device that received FDA 510(k) clearance on 2019-03-08. The listed applicant is DRGEM Corporation. The 510(k) number is K182537.

When did RADMAX Digital Imaging Software receive FDA 510(k) clearance?

RADMAX Digital Imaging Software received FDA 510(k) clearance on 2019-03-08, under 510(k) number K182537.

Who is the listed applicant for RADMAX Digital Imaging Software?

The FDA 510(k) record lists DRGEM Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RADMAX Digital Imaging Software?

The FDA product code for RADMAX Digital Imaging Software is LLZ.

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Related Devices (Code: LLZ)

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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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