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FDA 510(k)

XOFT AXXENT CERVICAL APPLICATORS

K-Number: K123442 · 2013-02-27

ApplicantIcad, Inc.
Decision Date2013-02-27
Product CodeJAQ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

XOFT AXXENT CERVICAL APPLICATORS is the device name listed in this FDA 510(k) record. The listed applicant is Icad, Inc.. It received FDA 510(k) clearance on 2013-02-27 under 510(k) number K123442. The device is classified under product code JAQ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the XOFT AXXENT CERVICAL APPLICATORS?

XOFT AXXENT CERVICAL APPLICATORS is a medical device that received FDA 510(k) clearance on 2013-02-27. The listed applicant is Icad, Inc.. The 510(k) number is K123442.

When did XOFT AXXENT CERVICAL APPLICATORS receive FDA 510(k) clearance?

XOFT AXXENT CERVICAL APPLICATORS received FDA 510(k) clearance on 2013-02-27, under 510(k) number K123442.

Who is the listed applicant for XOFT AXXENT CERVICAL APPLICATORS?

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

What is the FDA product code for XOFT AXXENT CERVICAL APPLICATORS?

The FDA product code for XOFT AXXENT CERVICAL APPLICATORS is JAQ.

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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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