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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 a medical device manufactured by DRGEM Corporation. It received FDA 510(k) clearance on 2019-03-08 under approval 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. It is manufactured by DRGEM Corporation. The 510(k) number is K182537.

When was RADMAX Digital Imaging Software approved by the FDA?

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

What company makes RADMAX Digital Imaging Software?

RADMAX Digital Imaging Software is manufactured by DRGEM Corporation.

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 PubMed Literature

PMID: 42204020 A Minimal UDI-DICOM Mapping Profile and Validation Artifact for Medical-Device Imaging Workflows. Journal of imaging informatics in medicine (2026) PMID: 42174919 Automating Safety Surveillance for Software-Based Medical Devices: Insights from FDA MAUDE Data. Studies in health technology and informatics (2026) PMID: 42127793 Ethical Responsibility in the Off-Label Use of AI in Medical Imaging. The Journal of clinical ethics (2026) PMID: 41476571 Digital pathology imaging artificial intelligence in cancer research and clinical trials: An NCI workshop report. Journal of pathology informatics (2026)

Other Devices by DRGEM Corporation

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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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