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)
support@4DMedical.com | https://4DMedical.com/ventilation-support
Los Angeles Office 21600 Oxnard St. Suite #300 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|
|XV Technology Ventilation Report||Class II|
|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)|