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FDA 510(k) Application Details - K212690
Device Classification Name
More FDA Info for this Device
510(K) Number
K212690
Device Name
qXR-BT
Applicant
Qure.ai Technologies
Level 7, Commerz II, International Business park,
Oberoi Garden City, Goregaon(E)
Mumbai 400063 IN
Other 510(k) Applications for this Company
Contact
Bunty Kundnani
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
QIH
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/25/2021
Decision Date
12/21/2021
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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