FDA 510(k) Application Details - K951262

Device Classification Name System, Image Processing, Radiological

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510(K) Number K951262
Device Name System, Image Processing, Radiological
Applicant RADIONICS SOFTWARE APPLICATIONS, INC.
P.O. BOX 358
22 TERRY AVENUE
BURLINGTON, MA US
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Contact LINDA JALBERT
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Regulation Number 892.2050

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Classification Product Code LLZ
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Date Received 03/21/1995
Decision Date 11/13/1995
Decision SE - Substantially Equivalent
Classification Advisory Committee RA - Radiology
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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