MEDRAD PHASED ARRAY 1.5T SHOULDER IMAGING SURGACE COIL— 510(k) K964854

Name: FDA 510(k) clearance K964854
Creator: U.S. Food and Drug Administration
Published: 1997-02-11

Substantially Equivalent

Medrad, Inc.

FDA 510(k) clearance K964854 for MEDRAD PHASED ARRAY 1.5T SHOULDER IMAGING SURGACE COIL, Substantially Equivalent on 1997-02-11. Applicant: Medrad, Inc.. Device class: 2.

Clearance details

Applicant: Medrad, Inc.
Product code: Code MOS
Device class: Class 2
Regulation: 21 CFR 892.1000
Advisory panel: Radiology
Date received: 1996-12-03
Decision date: 1997-02-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pittsburgh, PA, 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.