# Mylabtwice Model 6200

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

- Canonical page: <https://devicerts.com/devices/mylabtwice-model-6200-iyn>
- Manufacturer: [Esaote S.p.A.](https://devicerts.com/manufacturers/esaote-s-p-a) (Italy)
- Name in the registry: MYLABTWICE, MODEL 6200
- Device class: Class II (US FDA)
- FDA product code: IYN

## Overview

*AI-generated summary, 2026-09-18. Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data is the record.*

The Mylabtwice Model 6200 is a portable ultrasound imaging system designed for diagnostic radiology applications. It provides real-time visualization of internal body structures using high-frequency sound waves, enabling clinicians to assess organs, tissues, and vascular systems for diagnostic purposes.

This device is supplied as a reusable, non-sterile medical instrument intended for use in clinical settings such as hospitals, outpatient clinics, and emergency departments. It operates within standard MRI safety guidelines for non-MRI environments and requires proper maintenance and calibration as outlined in manufacturer instructions. Authorized for use in the United States under FDA 510(k) clearance (K100931) and compliant with the Medical Device Directive (MDD)

## Registrations and authorizations

- **510(k)** · FDA 510(k) · United States · K100931 · decision 2010-06-25 · decision SESE · status: Active
- **EUDAMED** · CE/MDD · European Union · status: Active

## Recalls

No recall on record.

## Identifiers

- 510(k) Number: K100931 [FDA 510(k)]
- FDA product code: IYN [FDA 510(k)]

## Classification

- Device class: Class II [FDA 510(k)]
- Regulation: 21 CFR Part 892.1550 [FDA 510(k)]
- Advisory committee: Radiology [FDA 510(k)]
- FDA decision: SESE [FDA 510(k)]

## Source and citation

- Cite as: Mylabtwice Model 6200, Esaote S.p.A. deviCERTS medical device catalogue. https://devicerts.com/devices/mylabtwice-model-6200-iyn (data as of 2026-11-15).
- Data sources: [FDA 510(k)](https://open.fda.gov/apis/device/510k/), [EUDAMED](https://ec.europa.eu/tools/eudamed)
- Registry records last synced: 2026-10-22
- Statuses computed as of: 2026-11-15
- JSON: <https://devicerts.com/devices/mylabtwice-model-6200-iyn.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/mylabtwice-model-6200-iyn
- 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.