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FDA 510(k)

TOPAZ Mobile X-ray System (Models : TOPAZ-32D, TOPAZ-40D)

K-Number: K242015 · 2024-12-16

ApplicantDRGEM Corporation
Decision Date2024-12-16
Product CodeIZL
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

TOPAZ Mobile X-ray System (Models : TOPAZ-32D, TOPAZ-40D) is the device name listed in this FDA 510(k) record. The listed applicant is DRGEM Corporation. It received FDA 510(k) clearance on 2024-12-16 under 510(k) number K242015. 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 X-ray System (Models : TOPAZ-32D, TOPAZ-40D)?

TOPAZ Mobile X-ray System (Models : TOPAZ-32D, TOPAZ-40D) is a medical device that received FDA 510(k) clearance on 2024-12-16. The listed applicant is DRGEM Corporation. The 510(k) number is K242015.

When did TOPAZ Mobile X-ray System (Models : TOPAZ-32D, TOPAZ-40D) receive FDA 510(k) clearance?

TOPAZ Mobile X-ray System (Models : TOPAZ-32D, TOPAZ-40D) received FDA 510(k) clearance on 2024-12-16, under 510(k) number K242015.

Who is the listed applicant for TOPAZ Mobile X-ray System (Models : TOPAZ-32D, TOPAZ-40D)?

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 X-ray System (Models : TOPAZ-32D, TOPAZ-40D)?

The FDA product code for TOPAZ Mobile X-ray System (Models : TOPAZ-32D, TOPAZ-40D) 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 SystemK232178GXR-ES/ECS Diagnostic X-Ray System, (Models GXR-ES series, GXR-ECS series)K202572GXR-Series Diagnostic X-Ray SystemK202156DIAMOND-5A/6A/8A

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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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