# Volumetric Specimen Imager

> Active: United States. Medical device record on deviCERTS, compiled from public registries.

- Canonical page: <https://devicerts.com/devices/volumetric-specimen-imager-mwp>
- Manufacturer: [Clarix Imaging](https://devicerts.com/manufacturers/clarix-imaging) (FDA registration: United States)
- Device class: Class II (US FDA)
- FDA product code: MWP

## Overview

*AI-generated summary, 2026-09-19. Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data 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.

## Registrations and authorizations

- **510(k)** · FDA 510(k) · United States · K192939 · decision 2019-12-27 · decision SESE · status: Active

## Recalls

No recall on record.

## Identifiers

- 510(k) Number: K192939 [FDA 510(k)]
- FDA product code: MWP [FDA 510(k)]

## Classification

- Device class: Class II [FDA 510(k)]
- Regulation: 21 CFR Part 892.1680 [FDA 510(k)]
- Advisory committee: Radiology [FDA 510(k)]
- FDA decision: SESE [FDA 510(k)]

## Source and citation

- Cite as: Volumetric Specimen Imager, Clarix Imaging. deviCERTS medical device catalogue. https://devicerts.com/devices/volumetric-specimen-imager-mwp (data as of 2026-11-15).
- Data sources: [FDA 510(k)](https://open.fda.gov/apis/device/510k/)
- Registry records last synced: 2026-10-22
- Statuses computed as of: 2026-11-15
- JSON: <https://devicerts.com/devices/volumetric-specimen-imager-mwp.json>
- Licence: [CC BY 4.0](https://creativecommons.org/licenses/by/4.0/). The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms.
- Attribution: DevicErts, https://devicerts.com/devices/volumetric-specimen-imager-mwp
- Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails.