FDA 510(k), K193293, XV Lung Ventilation Analysis Software

510(K) Number: K193293
Device Name: XV Lung Ventilation Analysis Software
Manufacturer: 4Dx Limited
Device Classification Name: System, X-Ray, Tomography, Computed
Regulation Number: 892.1750
Classification Product Code: JAK
Date Received: 11/27/2019
Decision Date: 05/14/2020
Regulation Medical Specialty: Radiology

500 pages (2,284 of 2,789 pages are fully redacted)