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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 K001499
Device Name PHORMAX EAGLE SCANNER SYSTEM
Applicant
PHORMAX CORP.
2081 LONGDEN CIRCLE
LOS ALTOS,  CA  94024
Applicant Contact SHEILA W PICKERING
Correspondent
PHORMAX CORP.
2081 LONGDEN CIRCLE
LOS ALTOS,  CA  94024
Correspondent Contact SHEILA W PICKERING
Regulation Number892.1680
Classification Product Code
MQB  
Date Received05/15/2000
Decision Date 12/27/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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