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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 the device name listed in this FDA 510(k) record. The listed applicant is Samsung Electronics Co., Ltd.. It received FDA 510(k) clearance on 2016-11-15 under 510(k) 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. The listed applicant is Samsung Electronics Co., Ltd.. The 510(k) number is K162278.

When did Digital Diagnostic Mobile X-ray System receive FDA 510(k) clearance?

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

Who is the listed applicant for Digital Diagnostic Mobile X-ray System?

The FDA 510(k) record lists Samsung Electronics Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing Samsung Electronics Co., Ltd. as applicant

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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.

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.K251710Mobile X-ray unit (!M1)Solutions For Tomorrow AB

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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