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FDA 510(k) Application Details - K141922
Device Classification Name
System, Image Management, Ophthalmic
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510(K) Number
K141922
Device Name
System, Image Management, Ophthalmic
Applicant
INTELLIGENT RETINAL IMAGING SYSTEMS, LLC
300 BRICKSTONE SQUARE
ANDOVER, MA 01810 US
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Contact
RYAN BOUCHARD
Other 510(k) Applications for this Contact
Regulation Number
892.2050
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Classification Product Code
NFJ
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More FDA Info for this Product Code
Date Received
07/16/2014
Decision Date
02/27/2015
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
RA - Radiology
Review Advisory Committee
OP - Ophthalmic
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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