MRGFUS PELVIC PA COIL MODEL 1.0— 510(k) K111060

Name: FDA 510(k) clearance K111060
Creator: U.S. Food and Drug Administration
Published: 2011-09-09

Substantially Equivalent

Insightech, Ltd.

FDA 510(k) clearance K111060 for MRGFUS PELVIC PA COIL MODEL 1.0, Substantially Equivalent on 2011-09-09. Applicant: Insightech, Ltd.. Device class: 2.

Clearance details

Applicant: Insightech, Ltd.
Product code: Code MOS
Device class: Class 2
Regulation: 21 CFR 892.1000
Advisory panel: Radiology
Date received: 2011-04-18
Decision date: 2011-09-09
Decision: Substantially Equivalent
Clearance type: Special
Location: Tirat Carmel, IL

Download summary PDF View on FDA.gov ↗

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