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MRI Patient Monitoring System Tesla M3

by Mipm Mammendorfer Institut Fur Physik Und Medizin

510(k) K142032

Active European Union and United States

CE MDR 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K142032↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK142032 Date7 May 2015ClearedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

510(k) Number
FDA Product Code
MWI
Device Class
Class II
Regulation
21 CFR Part 870.2300
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 18 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 MRI Patient Monitoring System Tesla M3 is a medical device classified as a patient monitor designed specifically for real-time monitoring of vital signs during magnetic resonance imaging (MRI) procedures. It integrates physiological parameters such as ECG, blood pressure, and oxygen saturation to ensure patient safety within the MRI environment, where traditional monitoring may be limited by electromagnetic interference.

This system is supplied as a standalone unit with a user interface optimized for MRI compatibility, including casters for mobility. It is intended for single-use or reusable applications in MRI facilities, adhering to FDA 510(k) clearance (K142032) and MDR compliance. The device is non-magnetic and designed for use within MRI environments, with no explicit sterility requirements stated in the specifications.

Other devices from Mammendorfer Institut Fur Physik Und Medizin GmbH

Questions

AI-generated answers, 18 Sep 2026

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

  • What types of vital signs does the MRI Patient Monitoring System Tesla M3 measure during MRI procedures, and why is this important in an MRI environment?

    The MRI Patient Monitoring System Tesla M3 measures ECG (heart rhythm), blood pressure, and oxygen saturation (SpO₂) in real-time. This is critical in an MRI environment because traditional monitoring devices can be unreliable due to electromagnetic interference from the MRI machine, potentially compromising patient safety during the procedure.

  • Is the MRI Patient Monitoring System Tesla M3 designed for single-use or reusable applications, and what does this mean for maintenance in an MRI facility?

    The system is explicitly designed for both single-use and reusable applications, allowing facilities to choose based on their infection control protocols and operational needs. If reused, proper cleaning and maintenance protocols must be followed to ensure device reliability and patient safety, though no explicit sterility requirements are stated in the specifications.

  • How is the Tesla M3 physically structured for use in an MRI facility, and does it pose any risks related to magnetic interference?

    The Tesla M3 is supplied as a standalone, mobile unit with casters for easy movement within an MRI facility. It is explicitly designed as non-magnetic, meaning it does not interfere with the MRI environment or pose risks to imaging quality or patient safety during procedures.

  • What regulatory pathways has the MRI Patient Monitoring System Tesla M3 followed, and which advisory committee was involved in its review?

    The Tesla M3 has undergone FDA 510(k) clearance (K142032) under the Traditional pathway, determined to be substantially equivalent to a predicate device. The review was conducted by the Cardiovascular (CV) Advisory Committee, reflecting its focus on monitoring cardiovascular parameters like ECG and blood pressure.

  • Does the Tesla M3 require any special storage conditions, and what should facilities consider when integrating it into their MRI workflow?

    The specifications do not specify special storage conditions, but since it is designed for MRI compatibility and mobility (with casters), facilities should store it in a clean, dry environment away from direct sunlight or extreme temperatures. Integration into workflows should account for its real-time monitoring capabilities to ensure seamless patient safety during MRI procedures.