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Vertex System

FDA 510(k)

Class II (US FDA 510(k))

510(k) K002822

by Medical Positioning, Inc.

Identifiers

510(k) Number
K002822 FDA 510(k)
FDA Product Code
DPS FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 870.2340 FDA 510(k)
Regulation Number
870.2340 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Vertex System is a diagnostic imaging positioning device classified under the product code DPS (Diagnostic Positioning System). It is designed to provide precise patient positioning for improved imaging outcomes in medical procedures, particularly in cardiology and vascular diagnostics.

This system is intended for use in clinical settings such as radiology and cardiology departments. Supplied sterile or non-sterile as specified by the manufacturer, it is reusable and must be cleaned and maintained according to facility protocols. The device is MRI-safe as per its design specifications and is authorised under FDA 510(k) clearance (K002822).

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 - MedicalPositioning, Contact Us - Vertex Systems, MedicalPositioning - LinkedIn, VERTEX SYSTEM (K002822) — FDA 510(k) | Innolitics, Sean Bitting - CEO at Vertex Systems Inc | LinkedIn

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Medical Positioning, Inc.

Sources (1)

  • FDA 510(k) K002822 24 fields · synced Sep 20, 2026