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HAMILTON-MR1

FDA 510(k)

Class II (US FDA 510(k))

510(k) K122438

by Hamilton Medical AG

Identifiers

510(k) Number
K122438 FDA 510(k)
FDA Product Code
CBK FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 868.5895 FDA 510(k)
Regulation Number
868.5895 FDA 510(k)
Advisory Committee
Anesthesiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Hamilton-MR1 is a ventilator designed for facility use that can withstand a static magnetic field of up to 50 mT, allowing it to be positioned close to MRI scanners. It combines reliability and high performance with patient-adaptive modes that support advanced lung-protective strategies.

The device is intended for use in critical care departments for transporting ventilated patients to the MRI department. It is manufactured by Hamilton Medical AG and has received FDA 510K clearance as substantially equivalent. The device is designed for facility use and is not specified as single-use or reusable.

Frequently asked questions

What is the Hamilton-MR1 ventilator designed for?

The Hamilton-MR1 is designed for facility use and specifically intended for transporting ventilated patients to MRI departments. It combines reliability with high performance and patient-adaptive modes that support advanced lung-protective strategies.

Can the Hamilton-MR1 be used near MRI scanners?

Yes, the Hamilton-MR1 can withstand a static magnetic field of up to 50 mT, allowing it to be positioned close to MRI scanners, which is essential for patient transport during imaging procedures.

Is the Hamilton-MR1 a single-use device?

The Hamilton-MR1 is designed for facility use and is not specified as single-use or reusable in the device description, indicating it is intended for multiple patient uses within a healthcare facility.

What regulatory approvals does the Hamilton-MR1 have?

The Hamilton-MR1 has received FDA 510K clearance as substantially equivalent, with product code CBK and device class 2. It was reviewed by the Anesthesiology advisory committee and received clearance on November 20, 2013.

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: HAMILTON-MR1 - Intelligent Ventilation from ICU to MRI | Hamilton Medical, PDF HAMILTON-MR1-brochure-en-689332, PDF HAMILTON-MR1 Installation Guide - Manuals+

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Hamilton Medical AG

Sources (1)

  • FDA 510(k) K122438 24 fields · synced Sep 21, 2026