FDA 510(k) Application Details - DEN240047

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN240047
Device Name	Allix5
Applicant	Clairity, Inc. 201 W 5th St., Ste 1500 Austin, TX 78701 US Other 510(k) Applications for this Company
Contact	Kris Zeschin Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	SEZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/06/2024
Decision Date	05/30/2025
Decision	DENG -
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status
Type	Direct
Reviewed By Third Party	N
Expedited Review