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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
Predetermined Change
Control Plan Authorized
No
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