FDA 510(k) Application Details - K232147

Device Classification Name	More FDA Info for this Device
510(K) Number	K232147
Device Name	CAAS Workstation
Applicant	Pie Medical Imaging B.V. Philipsweg 1 Maastricht 6227 AJ NL Other 510(k) Applications for this Company
Contact	Annemiek Bouts Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QHA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/19/2023
Decision Date	04/09/2024
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