FDA 510(k) Application Details - K243903

Device Classification Name	X-Ray, Tomography, Computed, Dental   More FDA Info for this Device
510(K) Number	K243903
Device Name	X-Ray, Tomography, Computed, Dental
Applicant	RAY Co., Ltd. 1F~3F, 4F(Part), 5F, 265, Daeji-Ro, Suji-gu Yongin-si 16882 KR Other 510(k) Applications for this Company
Contact	Soo Ji Huh Other 510(k) Applications for this Contact
Regulation Number	892.1750   More FDA Info for this Regulation Number
Classification Product Code	OAS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/19/2024
Decision Date	03/12/2025
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