# K062324: Mri Monitor with L-CANE05 and L-CANE05A Software and Module Options N-Psngv, N-PSNG, N-SNGV, N-SNG, N-PSN, N-SN

- Pathway: 510(k) (Traditional)
- Applicant: GE Healthcare
- Decided: Dec 6, 2006 after 119 days
- Product code: MHX (Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms))
- Device class: 2
- Regulation: 21 CFR 870.1025
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K002478 (2000). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061185: Datex-Ohmeda S/5 Compact Anesthesia Monitor with L-CANE05A and L-CANE05A Software, GE Healthcare (2006) Summary page 2.
- K051092: Datex-Ohmeda S/5 Compact Airway Module (Model Family E-Caiovx) E-Caiovx, E-Caiov, E-Caio, E-Covx, E-Cov, E-CO & Accesacc, GE Healthcare (2005) Summary page 2.
- K051217: Datex-Ohmeda Prestin Module (Model Family E-Prestin, Including E-Prestin, E-Restin, E=Pretin, E-PP and E-PT/E-P), GE Healthcare (2006) Summary page 4.

## Cited in the summary but kept off the family tree
- K980651: D-E MRI Monitor. Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 2.

## Indications for use
The MRI Monitor with L-CANEO5 or L-CANE05A software, module options N-PSNGV, N-PSNG, N-SNGV, N-SNG, N-PSN, N-SN, E-MRICAiOVX, E-MRICAJOV, E-MRICAiO, E-MRICO and accessories is indicated for monitoring of hemodynamic (comprising ECG (including heart rate, ST-segment and arrhythmia), NIBP, SpO2, and invasive blood pressure), respiration (CO2, 02, N20, anesthetic agents, anesthetic agent identification and respiration rate) ventilation (airway pressure, volume and flow) and gas exchange (Oxygen Consumption V02, Carbon Dioxide production VC02, Respiratory Quotient RQ, and Energy Expenditure, EE, Gas exchange monitoring is not indicated in the presence of N20+02 mixtures), status of hospital patients during magnetic resonance scanning. The NIBP measurement is indicated for patients who weigh 5kg (11 lb) and up. The MRI Monitor with L-CANEO5 or L-CANE05A software is also indicated for documenting patient care related information. The MRI Monitor with L-CANEO5 or L-CANEOSA software, module options N-PSNGV, N-PSNG, N-SNGV, N-SNG, N-PSN, N-SN, E-MRICAiOVX, E-MRICAiOV, E-MRICAiO, E-MRICO and accessories is indicated for use inthe MR environment up to 300 Gauss with static magnets up to 3.0 Tesla. SpO2 and EGG monitoring is indicated only with accessories (OXY-FMR, OXY-WMR, 897986 (ECG cable, AAMI) and 897987, EGG Cable, lEG) specifically designed for the MR environment. The MRI Monitor with L-CANE05 or L-CANEO5A software is indicated for use by qualified medical personnel only.

Source page: https://510kreport.com/device/K062324
Methodology: https://510kreport.com/methodology