FDA 510(k) Application Details - K242338

Device Classification Name	More FDA Info for this Device
510(K) Number	K242338
Device Name	Cleerly LABS (v2.0)
Applicant	Cleerly, Inc. 1099 18th St Suite 2860 Denver, CO 80202 US Other 510(k) Applications for this Company
Contact	Kristen DeJeu 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	08/07/2024
Decision Date	03/07/2025
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