Product Regulatory Information

Manufacturer Information

XV Lung Ventilation Analysis Software is manufactured by 4DMedical Limited of which 4DMedical Incorporated (USA) is a wholly owned subsidiary.

Phone US: + 1 833 XV SCANS (1 833 98 72267) |
Los Angeles Office 21255 Burbank Blvd, Suite #120, Woodland Hills, California 91367 USA


Risk Identification and Mitigation

The device is designed and manufactured under the Quality System Regulations as outlined in 21 CFR Part 820. The device labeling contains instructions for use and any necessary cautions and warnings for safe and effective use of the device. Risk management is ensured via a risk analysis, and risk control(s) have been implemented to mitigate identified potential hazards (conforming with “ISO 14971:2007 Medical devices –Application of risk management to medical devices”). Testing for verification and validation of the device supports that all software specifications have met the acceptance criteria.


Global Regulatory Clearances for 4DMedical Products


Agency Food and Drug Administration (FDA)
Register Establishment & Device Listing database
Listed entity 4Dx
XV Technology Ventilation Report Class II
Reference number K193293



Agency TGA
ARTG No. 344948
Product Name X-ray system, diagnostic, computed tomography, application program software
Sponsor Name 4DMedical Limited
Sponsor’s Own Reference XV Lung Ventilation Analysis Software (XV LVAS)