FDA 510(k) Application Details - K250427

Device Classification Name	More FDA Info for this Device
510(K) Number	K250427
Device Name	TAIMedImg DeepMets
Applicant	Taiwan Medical Imaging Co., Ltd. 3F., No. 1, Fuxing 4th Rd., Qianzhen Dist., Kaohsiung City 806611 TW Other 510(k) Applications for this Company
Contact	Bo-Ru Lin Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QKB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/14/2025
Decision Date	05/28/2025
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