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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name solid state x-ray imager (flat panel/digital imager)
510(K) Number K120380
Device Name SATURN 8000
Applicant
NEW MEDICAL CO., LTD.
1441 kem way
walnut,  CA  91789
Contact jun-hsiung lin
Regulation Number892.1650
Classification Product Code
MQB  
Date Received02/07/2012
Decision Date 03/09/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Radiology
Review Advisory Committee Radiology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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