FDA 510(k), K180192, Emprint Ablation Visualization Application

510(K) Number: K180192
Device Name: Emprint Ablation Visualization Application
Manufacturer: Patti L. Arndt
Device Classification Name: System, Image Processing, Radiological
Regulation Number: LLZ
Classification Product Code: 01/24/2018
Date Received: 03/21/2018
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Radiology

Number of pages: 399 after fully redacted pages were removed (original file was 3037 pages)