FDA 510(k) Application Details - K042821

Device Classification Name Solid State X-Ray Imager (Flat Panel/Digital Imager)

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510(K) Number K042821
Device Name Solid State X-Ray Imager (Flat Panel/Digital Imager)
Applicant ANRAD CORP.
8 CENTENNIAL DRIVE
PEABODY, MA 01960 US
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Contact DONALD J SHERRATT
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Regulation Number 892.1650

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Classification Product Code MQB
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Date Received 10/12/2004
Decision Date 10/22/2004
Decision SESE - SUBST EQUIV
Classification Advisory Committee RA - Radiology
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Summary
Type Abbreviated
Reviewed By Third Party Y
Expedited Review



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