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FDA 510(k)

HF 718BD X-Ray System

K-Number: K160857 · 2017-02-24

Decision Date2017-02-24
Product CodeKPR
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

HF 718BD X-Ray System is the device name listed in this FDA 510(k) record. The listed applicant is Arquilla, Inc. Dba X-Cel X-Ray Corporation. It received FDA 510(k) clearance on 2017-02-24 under 510(k) number K160857. The device is classified under product code KPR. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HF 718BD X-Ray System?

HF 718BD X-Ray System is a medical device that received FDA 510(k) clearance on 2017-02-24. The listed applicant is Arquilla, Inc. Dba X-Cel X-Ray Corporation. The 510(k) number is K160857.

When did HF 718BD X-Ray System receive FDA 510(k) clearance?

HF 718BD X-Ray System received FDA 510(k) clearance on 2017-02-24, under 510(k) number K160857.

Who is the listed applicant for HF 718BD X-Ray System?

The FDA 510(k) record lists Arquilla, Inc. Dba X-Cel X-Ray Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HF 718BD X-Ray System?

The FDA product code for HF 718BD X-Ray System is KPR.

Related Devices (Code: KPR)

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.

Official Source

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