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FDA 510(k) Application Details - K190368
Device Classification Name
Solid State X-Ray Imager (Flat Panel/Digital Imager)
More FDA Info for this Device
510(K) Number
K190368
Device Name
Solid State X-Ray Imager (Flat Panel/Digital Imager)
Applicant
Canon, Inc.
30-2 Shimomaruko, 3-Chrome, Ohta-Ku
Tokyo 146-8501 JP
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Contact
Yamazaki Tatsuya
Other 510(k) Applications for this Contact
Regulation Number
892.1650
More FDA Info for this Regulation Number
Classification Product Code
MQB
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
02/15/2019
Decision Date
03/13/2019
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
RA - Radiology
Review Advisory Committee
RA - Radiology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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