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FDA 510(k)

MDR17 Mobile Direct Radiographic System

K-Number: K173018 · 2017-11-20

ApplicantDel Medical, Inc.
Decision Date2017-11-20
Product CodeIZL
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MDR17 Mobile Direct Radiographic System is the device name listed in this FDA 510(k) record. The listed applicant is Del Medical, Inc.. It received FDA 510(k) clearance on 2017-11-20 under 510(k) number K173018. 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 MDR17 Mobile Direct Radiographic System?

MDR17 Mobile Direct Radiographic System is a medical device that received FDA 510(k) clearance on 2017-11-20. The listed applicant is Del Medical, Inc.. The 510(k) number is K173018.

When did MDR17 Mobile Direct Radiographic System receive FDA 510(k) clearance?

MDR17 Mobile Direct Radiographic System received FDA 510(k) clearance on 2017-11-20, under 510(k) number K173018.

Who is the listed applicant for MDR17 Mobile Direct Radiographic System?

The FDA 510(k) record lists Del Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MDR17 Mobile Direct Radiographic System?

The FDA product code for MDR17 Mobile Direct Radiographic System is IZL.

Other records listing Del Medical, Inc. 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.

K223550DMX

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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