# K153739: MRI Patient Monitor TeslaDUO

- Pathway: 510(k) (Traditional)
- Applicant: Mipm Mammendorfer Institut Fur Physik Und Medizin
- Decided: Jun 28, 2016 after 183 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: 10 generations back to K946306 (1995). 36 ancestors in all.
No later device cites it as a predicate yet.
0 of 37 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142032: Mri Patient Monitoring System Tesla M3, Mipm Mammendorfer Institut Fur Physik Und Medizin (2015) Summary page 5.

## Indications for use
The MRI Patient Monitor TeslaDUO is intended for monitoring of vital signs during MRI examinations (MRI procedures) of patients. The TeslaDUO is intended for use in the Adult and Pediatric populations for continuous monitoring of Pulse Oximetry (SpO2). The TeslaDUO is intended for use in the Adult, Pediatric and Neonatal populations for continuous monitoring of Non-Invasive Blood Pressure (NIBP). The TeslaDUO is intended for use by health care professionals.

Source page: https://510kreport.com/device/K153739
Methodology: https://510kreport.com/methodology