← Back to catalogue

A-View

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K170338

by Stroke2prevent B.V.

Identifiers

510(k) Number
K170338 FDA 510(k)
FDA Product Code
ITX FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 892.1570 FDA 510(k)
Regulation Number
892.1570 FDA 510(k)
Advisory Committee
Radiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The A-View is a medical imaging device classified under the product code ITX, designed for capturing detailed images of the ascending aorta, aortic arch, and descending thoracic aorta. It facilitates the detection of atherosclerosis, diagnosis of aortic diseases, and assessment of vascular flow, providing critical diagnostic information for cardiovascular evaluation.

A-View is supplied by Stroke2prevent B.V. and is intended for use in clinical radiology settings. The device is regulated under the FDA 510(k) pathway with a Traditional clearance (K170338) and complies with the Medical Devices Directive (MDD). No specific sterility or single-use/reusable designation is stated in the provided data, though its imaging function aligns with reusable medical imaging equipment standards.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: About - Stroke2Prevent, A-View Trademark - Stroke2prevent Bv - Bizapedia, A-View, A World Intellectual Property Organization Trademark of ..., Stroke2Prevent B.V. - LinkedIn

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDD

United States Active

FDA_510K

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Stroke2prevent B.V.

Sources (2)

  • FDA 510(k) K170338 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced Jun 5, 2026