Volumetric Specimen Imager: FDA 510(k) K192939 cleared 2019

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK192939	Date27 Dec 2019Cleared	StatusActive

Official records

FDA 510(k) database 510(k) number K192939

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number: K192939
FDA product code: MWP

Device class: Class II
Regulation: 21 CFR Part 892.1680
Advisory committee: Radiology
FDA decision: SESE Substantially Equivalent

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Faxitron VisionCT K173309 9 May 2018 FDA record · FDA summary

Source: 510k-lineage (choiben314), CC BY 4.0

Overview

AI-generated summary, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

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.

Similar devices

Other devices filed under FDA product code MWP (Cabinet, X-Ray System).

Other devices from Clarix Imaging

Clarix Imaging Corps VSI-1

Class II