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FDA 510(k)

MAMMOSITE II RADIATION THERAPY SYSTEM

K-Number: K091378 · 2009-07-02

ApplicantHologic, Inc.
Decision Date2009-07-02
Product CodeJAQ
Advisory CommitteeRA
DecisionUnknown

Device Summary

MAMMOSITE II RADIATION THERAPY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Hologic, Inc.. It received FDA 510(k) clearance on 2009-07-02 under 510(k) number K091378. The device is classified under product code JAQ. It was reviewed by the RA advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the MAMMOSITE II RADIATION THERAPY SYSTEM?

MAMMOSITE II RADIATION THERAPY SYSTEM is a medical device that received FDA 510(k) clearance on 2009-07-02. The listed applicant is Hologic, Inc.. The 510(k) number is K091378.

When did MAMMOSITE II RADIATION THERAPY SYSTEM receive FDA 510(k) clearance?

MAMMOSITE II RADIATION THERAPY SYSTEM received FDA 510(k) clearance on 2009-07-02, under 510(k) number K091378.

Who is the listed applicant for MAMMOSITE II RADIATION THERAPY SYSTEM?

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

What is the FDA product code for MAMMOSITE II RADIATION THERAPY SYSTEM?

The FDA product code for MAMMOSITE II RADIATION THERAPY SYSTEM 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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