ABOUT 4DMEDICAL

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.

4DMedical
Phone: +61 03 9545 5940
Email: support@4DMedical.com
4DMedical.com/support

Level 7/700 Swanston Street, Carlton VIC 3053, Australia

Product Instructions for Use (IFUs)

XV LVAS
United States: Download
Australia & New Zealand: Download

CT LVAS
United States: Download
Australia & New Zealand: Download

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)
Agency
TGA
ARTG No.

424192

Product Name

X-ray system, diagnostic, computed tomography, application program software
Sponsor Name
4DMedical Limited
Sponsor’s Own Reference
CT Lung Ventilation Analysis Software (CT LVAS)

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