← Back to catalogue

Volumetric Specimen Imager

FDA 510(k)

Class II (US FDA 510(k))

510(k) K192939

by Clarix Imaging

Identifiers

510(k) Number
K192939 FDA 510(k)
FDA Product Code
MWP FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 892.1680 FDA 510(k)
Regulation Number
892.1680 FDA 510(k)
Advisory Committee
Radiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Volumetric Specimen Imager is a cabinet X-ray system designed for radiology applications. It provides two- and three-dimensional digital imaging of specimens.

The device is supplied as a non-sterile, reusable system intended for use in clinical imaging settings. It has received FDA 510(k) clearance under product code MWP and regulation number 892.1680, with the manufacturer located at 2242 Harrison St. Suite 201, Chicago, IL 60612.

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: Volumetric Specimen Imaging - Clarix Imaging, Clarix Imaging - True 3D Specimen Radiography, PDF Journey Through Your Specimen With Clarix Imaging Vsi-360 Tm

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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

Manufacturer

Manufacturer
Clarix Imaging

Sources (1)

  • FDA 510(k) K192939 24 fields · synced Sep 19, 2026