FDA 510(k) Application Details - K193381

Device Classification Name	System,Planning,Radiation Therapy Treatment   More FDA Info for this Device
510(K) Number	K193381
Device Name	System,Planning,Radiation Therapy Treatment
Applicant	LifeLine Software, Inc. 3304 S Broadway Ave, Suite 200 Tyler, TX 75701 US Other 510(k) Applications for this Company
Contact	Craig Laughton Other 510(k) Applications for this Contact
Regulation Number	892.5050   More FDA Info for this Regulation Number
Classification Product Code	MUJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/05/2019
Decision Date	12/31/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Statement
Type	Special
Reviewed By Third Party	N
Expedited Review