FDA 510(k) Application Details - K234009

Device Classification Name	More FDA Info for this Device
510(K) Number	K234009
Device Name	Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)
Applicant	Mighty Oak Medical 750 W. Hampden Ave Suite 120 Englewood, CO 80110 US Other 510(k) Applications for this Company
Contact	Mark Wylie 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	12/19/2023
Decision Date	07/12/2024
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