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FDA 510(k)

TOPAZ Mobile DR System

K-Number: K201124 · 2020-05-19

ApplicantDRGEM Corporation
Decision Date2020-05-19
Product CodeIZL
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

TOPAZ Mobile DR System is a medical device manufactured by DRGEM Corporation. It received FDA 510(k) clearance on 2020-05-19 under approval number K201124. The device is classified under product code IZL. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TOPAZ Mobile DR System?

TOPAZ Mobile DR System is a medical device that received FDA 510(k) clearance on 2020-05-19. It is manufactured by DRGEM Corporation. The 510(k) number is K201124.

When was TOPAZ Mobile DR System approved by the FDA?

TOPAZ Mobile DR System received FDA 510(k) clearance on 2020-05-19, under approval number K201124.

What company makes TOPAZ Mobile DR System?

TOPAZ Mobile DR System is manufactured by DRGEM Corporation.

What is the FDA product code for TOPAZ Mobile DR System?

The FDA product code for TOPAZ Mobile DR System is IZL.

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Related PubMed Literature

PMID: 39943397 Clinical Validation of a Video-Otoscopy-Based Medical Device for the Remote Diagnosis of Ear Complaints. Sensors (Basel, Switzerland) (2025)

Other Devices by DRGEM Corporation

K192453DIAMOND-5A/6A/8A K192364GXR-Series Diagnostic X-Ray System K183292Topaz Mobile DR System K182537RADMAX Digital Imaging Software K183388JADE Mobile X-Ray K202572GXR-Series Diagnostic X-Ray System

View all 13 devices →

Related Devices (Code: IZL)

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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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