FDA 510(k) Application Details - K241922

Device Classification Name	More FDA Info for this Device
510(K) Number	K241922
Device Name	Myomics
Applicant	Phantomics Inc. 152, Magokseo-ro, Gangseo-gu A-609 Seoul 07788 KR Other 510(k) Applications for this Company
Contact	Soeun Baek 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	07/01/2024
Decision Date	02/28/2025
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