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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 a medical device manufactured by Del Medical, Inc.. It received FDA 510(k) clearance on 2017-11-20 under approval 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. It is manufactured by Del Medical, Inc.. The 510(k) number is K173018.

When was MDR17 Mobile Direct Radiographic System approved by the FDA?

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

What company makes MDR17 Mobile Direct Radiographic System?

MDR17 Mobile Direct Radiographic System is manufactured by Del Medical, Inc..

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

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

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Related PubMed Literature

PMID: 39943397 Clinical Validation of a Video-Otoscopy-Based Medical Device for the Remote Diagnosis of Ear Complaints. Sensors (Basel, Switzerland) (2025) PMID: 39892748 Long-term Safety and Performance of a Suprachoroidal Pressure Sensor System: Results of the EYEMATE-SC Trial Follow-up Study. Ophthalmology (2025)

Other Devices by Del Medical, Inc.

K223550DMX

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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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