# K142032: Mri Patient Monitoring System Tesla M3

- Pathway: 510(k) (Traditional)
- Applicant: Mipm Mammendorfer Institut Fur Physik Und Medizin
- Decided: May 7, 2015 after 286 days
- Product code: MWI (Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms))
- Device class: 2
- Regulation: 21 CFR 870.2300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K946306 (1995). 35 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 40 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071802: Tesla Guard, Model Eft G04, Mammendorfer Institut Fur Physik Und Medizin GmbH (2007) Summary page 4.

## Most influential descendants
- K172200: 3880 MRI Patient Monitoring System (2017), 2 descendants of its own
- K180903: 3880 MRI Patient Monitoring System (2019), 0 descendants of its own
- K182900: 3880 MRI Patient Monitoring System (2018), 0 descendants of its own
- K153739: MRI Patient Monitor TeslaDUO (2016), 0 descendants of its own

## Indications for use
The MRI Patient Monitoring System Tesla M3 is intended for monitoring of vital signs during MRI examinations (MRI procedures) of patients. The Tesla M3 is intended for use in the Adult, Pediatric and Neonatal populations for the continuous monitoring of Electrocardiogram (ECG), Non-Invasive Blood Pressure (NIBP), Invasive Blood Pressure (IBP), Temperature, Respiration, Capnography (etCO2), Oxygen and Anesthetic Agents. The Tesla M3 is intended for use in the Adult and Pediatric populations for the continuous monitoring of Pulse Oximetry (SpO2). The Tesla M3 is intended for use by health care professionals.

Source page: https://510kreport.com/device/K142032
Methodology: https://510kreport.com/methodology