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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, nuclear magnetic resonance imaging
510(k) Number K090080
Device Name CIRRUS OPEN
Applicant
MRI-TECH SP. ZO.O.
206 - 3820 CAMBIE STREET
VANCOUVER, BC,  CA V5Z 2X7
Applicant Contact ANITA CHAN
Correspondent
MRI-TECH SP. ZO.O.
206 - 3820 CAMBIE STREET
VANCOUVER, BC,  CA V5Z 2X7
Correspondent Contact ANITA CHAN
Regulation Number892.1000
Classification Product Code
LNH  
Date Received01/12/2009
Decision Date 03/23/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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