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FDA 510(k)

Digital Diagnostic Mobile X-ray System

K-Number: K162278 · 2016-11-15

ApplicantSamsung Electronics Co., Ltd.
Decision Date2016-11-15
Product CodeIZL
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Digital Diagnostic Mobile X-ray System is a medical device manufactured by Samsung Electronics Co., Ltd.. It received FDA 510(k) clearance on 2016-11-15 under approval number K162278. 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 Digital Diagnostic Mobile X-ray System?

Digital Diagnostic Mobile X-ray System is a medical device that received FDA 510(k) clearance on 2016-11-15. It is manufactured by Samsung Electronics Co., Ltd.. The 510(k) number is K162278.

When was Digital Diagnostic Mobile X-ray System approved by the FDA?

Digital Diagnostic Mobile X-ray System received FDA 510(k) clearance on 2016-11-15, under approval number K162278.

What company makes Digital Diagnostic Mobile X-ray System?

Digital Diagnostic Mobile X-ray System is manufactured by Samsung Electronics Co., Ltd..

What is the FDA product code for Digital Diagnostic Mobile X-ray System?

The FDA product code for Digital Diagnostic Mobile X-ray System is IZL.

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Related PubMed Literature

PMID: 40271230 When Software Becomes Medicine: Ignoring It May Soon Be Malpractice. Cureus (2025) PMID: 34657930 Editorial: Global Initiatives Support the Use and Regulation of Digital Health Technology During the COVID-19 Pandemic. Medical science monitor : international medical journal of experimental and clinical research (2021) PMID: 33371797 Developing a Qualification and Verification Strategy for Digital Tissue Image Analysis in Toxicological Pathology. Toxicologic pathology (2021) PMID: 31818387 How the FDA Regulates AI. Academic radiology (2020)

Other Devices by Samsung Electronics Co., Ltd.

K163115GC70 K160997GC85A K172229GC85A K171119GM85 K182183GC70, GU60A, GU60A-65, GF50, GR50A ; GR40CW ; GM85 ; GC85A K182647GC70

View all 24 devices →

Related Devices (Code: IZL)

K163063UC-5000 Mobile X-RaySource-Ray, Inc. K162990Optima XR240amxGe Medical Systems, LLC 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. K173018MDR17 Mobile Direct Radiographic SystemDel Medical, 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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