MRGFUS GENERAL PURPOSE AND BREAST COIL— 510(k) K061715

Name: FDA 510(k) clearance K061715
Creator: U.S. Food and Drug Administration
Published: 2006-07-28

Substantially Equivalent

Insightec Txsonics, Inc.

FDA 510(k) clearance K061715 for MRGFUS GENERAL PURPOSE AND BREAST COIL, Substantially Equivalent on 2006-07-28. Applicant: Insightec Txsonics, Inc.. Device class: 2.

Clearance details

Applicant: Insightec Txsonics, Inc.
Product code: Code MOS
Device class: Class 2
Regulation: 21 CFR 892.1000
Advisory panel: Radiology
Date received: 2006-06-19
Decision date: 2006-07-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dallas, TX, US

Download summary PDF View on FDA.gov ↗

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