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 a medical device manufactured by Arquilla, Inc. Dba X-Cel X-Ray Corporation. It received FDA 510(k) clearance on 2017-02-24 under approval 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. It is manufactured by Arquilla, Inc. Dba X-Cel X-Ray Corporation. The 510(k) number is K160857.
When was HF 718BD X-Ray System approved by the FDA?
HF 718BD X-Ray System received FDA 510(k) clearance on 2017-02-24, under approval number K160857.
What company makes HF 718BD X-Ray System?
HF 718BD X-Ray System is manufactured by Arquilla, Inc. Dba X-Cel X-Ray Corporation.
What is the FDA product code for HF 718BD X-Ray System?
The FDA product code for HF 718BD X-Ray System is KPR.
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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.