MAMMOSITE II RADIATION THERAPY SYSTEM— 510(k) K091378

Unknown

Hologic, Inc.

FDA 510(k) clearance K091378 for MAMMOSITE II RADIATION THERAPY SYSTEM, Unknown on 2009-07-02. Applicant: Hologic, Inc.. Device class: 2.

Clearance details

Applicant: Hologic, Inc.
Product code: Code JAQ
Device class: Class 2
Regulation: 21 CFR 892.5700
Advisory panel: Radiology
Date received: 2009-05-11
Decision date: 2009-07-02
Decision: Unknown
Clearance type: Special
Location: Malborough, MA, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.