FDA 510(k) Application Details - K211733

Device Classification Name	More FDA Info for this Device
510(K) Number	K211733
Device Name	Lunit INSIGHT CXR Triage
Applicant	Lunit Inc. 15th Floor, 27 Teheran-ro 2-gil Seoul 06241 KR Other 510(k) Applications for this Company
Contact	Seulhee Jung Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QFM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/04/2021
Decision Date	11/10/2021
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