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FDA 510(k)

Axxent Electronic Brachytherapy System Model 110 XP 1200

K-Number: K153570 · 2016-02-25

ApplicantIcad, Inc.
Decision Date2016-02-25
Product CodeJAD
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Axxent Electronic Brachytherapy System Model 110 XP 1200 is the device name listed in this FDA 510(k) record. The listed applicant is Icad, Inc.. It received FDA 510(k) clearance on 2016-02-25 under 510(k) number K153570. 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 Electronic Brachytherapy System Model 110 XP 1200?

Axxent Electronic Brachytherapy System Model 110 XP 1200 is a medical device that received FDA 510(k) clearance on 2016-02-25. The listed applicant is Icad, Inc.. The 510(k) number is K153570.

When did Axxent Electronic Brachytherapy System Model 110 XP 1200 receive FDA 510(k) clearance?

Axxent Electronic Brachytherapy System Model 110 XP 1200 received FDA 510(k) clearance on 2016-02-25, under 510(k) number K153570.

Who is the listed applicant for Axxent Electronic Brachytherapy System Model 110 XP 1200?

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 Axxent Electronic Brachytherapy System Model 110 XP 1200?

The FDA product code for Axxent Electronic Brachytherapy System Model 110 XP 1200 is JAD.

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Related Devices (Code: 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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