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FDA 510(k) Application Details - K150766
Device Classification Name
Solid State X-Ray Imager (Flat Panel/Digital Imager)
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510(K) Number
K150766
Device Name
Solid State X-Ray Imager (Flat Panel/Digital Imager)
Applicant
Carestream Health, Inc.
150 Verona Street
Rochester, NY 14608 US
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Contact
Carolyn L Wagner
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Regulation Number
892.1650
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Classification Product Code
MQB
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More FDA Info for this Product Code
Date Received
03/24/2015
Decision Date
06/24/2015
Decision
SESE - SUBST EQUIV
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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