Hitachi Medical Systems America, Inc. - August 4, 2009
Issue Date
Aug 04, 2009
Region
Central
Category
Device
$117.00
Address 1
1959 Summit Commerce Park
City
Quinsburg
State
OH
Zip/Postal Code
44087
Country
US
Inspection Range
Aug 04, 2009 - Aug 04, 2009
Pages
1
First Observation
Your firm's "in-house" oasis model MRI laser product lacks: a 21DFR Subchapter J ratification label; a class II non-interlocked protective housing label; a class II laser warning log type which conforms to either 21 CFR 1040.10 or to IEC 60825.
Investigator(s): James E. Frye