Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K190611
Device Classification Name
Solid State X-Ray Imager (Flat Panel/Digital Imager)
More FDA Info for this Device
510(K) Number
K190611
Device Name
Solid State X-Ray Imager (Flat Panel/Digital Imager)
Applicant
Vieworks Co., Ltd.
(Gwanyang-dong) 41-3, Burim-ro 170beon-gil
Anyang-si 431-060 KR
Other 510(k) Applications for this Company
Contact
Jordin Kim
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
03/11/2019
Decision Date
04/08/2019
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
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact