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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 a medical device manufactured by DRGEM Corporation. It received FDA 510(k) clearance on 2024-12-16 under approval 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. It is manufactured by DRGEM Corporation. The 510(k) number is K242015.

When was TOPAZ Mobile X-ray System (Models : TOPAZ-32D, TOPAZ-40D) approved by the FDA?

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

What company makes TOPAZ Mobile X-ray System (Models : TOPAZ-32D, TOPAZ-40D)?

TOPAZ Mobile X-ray System (Models : TOPAZ-32D, TOPAZ-40D) is manufactured by DRGEM Corporation.

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.

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Related PubMed Literature

PMID: 40775988 B-onic Suite: An Integrated Platform for Personalized Medical Devices, Real-Time Surgical Planning, and Enhanced Intraoperative Navigation. Studies in health technology and informatics (2025) PMID: 40563006 Toward Transparent AI-Enabled Patient Selection in Cosmetic Surgery by Integrating Reasoning and Medical LLMs. Aesthetic plastic surgery (2025) 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)

K163063UC-5000 Mobile X-RaySource-Ray, Inc. K162990Optima XR240amxGe Medical Systems, LLC K162278Digital Diagnostic Mobile X-ray SystemSamsung Electronics Co., Ltd. K162687Paragon 2Meridian Medical Systems, LLC K161345RadPRO® Mobile 40kW; RadPRO® Mobile 40kW FLEXPLUS, Model SM-40HF-B-D-VIRSedecal., Sa. K153059HF1202H PowerPlus Portable X-ray EquipmentMinxray, Inc.

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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