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FDA 510(k)

Topaz Mobile DR System

K-Number: K183292 · 2019-05-15

ApplicantDRGEM Corporation
Decision Date2019-05-15
Product CodeIZL
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Topaz Mobile DR System is the device name listed in this FDA 510(k) record. The listed applicant is DRGEM Corporation. It received FDA 510(k) clearance on 2019-05-15 under 510(k) number K183292. 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 2019-05-15. The listed applicant is DRGEM Corporation. The 510(k) number is K183292.

When did Topaz Mobile DR System receive FDA 510(k) clearance?

Topaz Mobile DR System received FDA 510(k) clearance on 2019-05-15, under 510(k) number K183292.

Who is the listed applicant for Topaz Mobile DR System?

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 Topaz Mobile DR System?

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

Other records listing DRGEM Corporation as applicant

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.

K260085RAYMO Mobile X-ray System (Model: RAYMO)K251443PROMOK242019GXR-Series Diagnostic X-Ray SystemK242015TOPAZ Mobile X-ray System (Models : TOPAZ-32D, TOPAZ-40D)K232178GXR-ES/ECS Diagnostic X-Ray System, (Models GXR-ES series, GXR-ECS series)K202572GXR-Series Diagnostic X-Ray System

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Related Devices (Code: IZL)

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.

K260236XLITEGEMSS HEALTHCARE CO., LTD.K253058Portable DR Imaging SystemShantou Institute of Ultrasonic Instruments Co., Ltd.K260085RAYMO Mobile X-ray System (Model: RAYMO)DRGEM CorporationK253185Lux HD Detectors, DRX-LC Detector, DRX-Revolution Mobile X-Ray SystemCarestream HealthK253244AirRay-mini 80A, AirRay-mini 90A, AirRay-mini 80F, AirRay-mini 90F (AirRay-mini)Poskom Co., Ltd.K250976Airbile-100Poskom Co., Ltd.

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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