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FDA 510(k) Application Details - K182551
Device Classification Name
Solid State X-Ray Imager (Flat Panel/Digital Imager)
More FDA Info for this Device
510(K) Number
K182551
Device Name
Solid State X-Ray Imager (Flat Panel/Digital Imager)
Applicant
iRay Technology Taicang Ltd.
No. 33 Xinggang Rd., Taicang Port Economic & Technological
Development Zone
Taicang 215434 CN
Other 510(k) Applications for this Company
Contact
Meng Li
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
09/17/2018
Decision Date
10/17/2018
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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