FDA 510(k) Application Details - K202414

Device Classification Name	System, Image Processing, Radiological   More FDA Info for this Device
510(K) Number	K202414
Device Name	System, Image Processing, Radiological
Applicant	Hyperfine Research, Inc 530 Old Whitfield St. Guilford, CT 06437 US Other 510(k) Applications for this Company
Contact	Robert Fasciano Other 510(k) Applications for this Contact
Regulation Number	892.2050   More FDA Info for this Regulation Number
Classification Product Code	LLZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/24/2020
Decision Date	01/07/2021
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