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FDA 510(k)

AXXENT RADIATION SHIELD - RIGID

K-Number: K111299 · 2011-07-20

ApplicantXoft, an Icad Company
Decision Date2011-07-20
Product CodeJAD
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

AXXENT RADIATION SHIELD - RIGID is the device name listed in this FDA 510(k) record. The listed applicant is Xoft, an Icad Company. It received FDA 510(k) clearance on 2011-07-20 under 510(k) number K111299. The device is classified under product code JAD. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AXXENT RADIATION SHIELD - RIGID?

AXXENT RADIATION SHIELD - RIGID is a medical device that received FDA 510(k) clearance on 2011-07-20. The listed applicant is Xoft, an Icad Company. The 510(k) number is K111299.

When did AXXENT RADIATION SHIELD - RIGID receive FDA 510(k) clearance?

AXXENT RADIATION SHIELD - RIGID received FDA 510(k) clearance on 2011-07-20, under 510(k) number K111299.

Who is the listed applicant for AXXENT RADIATION SHIELD - RIGID?

The FDA 510(k) record lists Xoft, an Icad Company as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AXXENT RADIATION SHIELD - RIGID?

The FDA product code for AXXENT RADIATION SHIELD - RIGID is JAD.

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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.

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