510(k) · Cleared
ClearedMri Monitor with L-CANE05 and L-CANE05A Software and Module Options N-Psngv, N-PSNG, N-SNGV, N-SNG, N-PSN, N-SN
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
GE Healthcare · MHX Monitor, Physiological, Patient (With Arrhythmia Detection Or Alarms)
Cleared on Dec 6, 2006 as substantially equivalent to K061185 (GE Healthcare, 2006) and 2 other predicates after a 119-day review. Its family tree reaches back 4 generations to 2000.
- Decided
- Dec 6, 2006
- Review
- 119 days
- Class
- Class II
- Product code
- MHX
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 4 generations to K002478 (2000). 8 ancestors in all, the oldest K001814 (2000). No later device cites it as a predicate yet.
- Root · 4 generations backK002478 S/5 Compact Anesthesia Monitor with S-00A05, S-00A06. L-00A07, L00A08Datex-Ohmeda, Inc. · 2000
- 3 generations backK022485 Datex-Ohmeda S/5 Compact Anesthesia Monitor with L-CANE02 and…Datex-Ohmeda · 2002
- 2 generations backK041790 Datex-Ohmeda S/5 Compact Anesthesia Monitor with L-CANE03 and…Datex-Ohmeda · 2004
- 1 generation backK061185 Datex-Ohmeda S/5 Compact Anesthesia Monitor with L-CANE05A and…GE Healthcare · 2006
- This deviceK062324 Mri Monitor with L-CANE05 and L-CANE05A Software and Module Options…GE Healthcare · 2006
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K002478 | S/5 Compact Anesthesia Monitor with S-00A05, S-00A06. L-00A07, L00A08 | Datex-Ohmeda, Inc. | 2000 | — |
| −3 | K022485 | Datex-Ohmeda S/5 Compact Anesthesia Monitor with L-CANE02 and L-CANE02A Software | Datex-Ohmeda | 2002 | — |
| −2 | K041790 | Datex-Ohmeda S/5 Compact Anesthesia Monitor with L-CANE03 and LCANE03A Software | Datex-Ohmeda | 2004 | — |
| −1 | K061185 | Datex-Ohmeda S/5 Compact Anesthesia Monitor with L-CANE05A and L-CANE05A… | GE Healthcare | 2006 | — |
| 0 (this device) | K062324 | Mri Monitor with L-CANE05 and L-CANE05A Software and Module Options N-Psngv… | GE Healthcare | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MHX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new MHX device
- #1 K251702 IntelliVue Patient Monitor MX750; IntelliVue…score 23.0 · 40 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| 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…PSNG, N-SNGV, N-SNG, N-PSN, N-SN, E-MRICAiOVX, E-MRICAiOV, E-MRICAiO, E- MRICO and accessories is substantially equivalent to the predicates D-E MRI Monitor (980651), S/5TM CAM with L-CANE05 and L-CANE05A (K061185), Datex-Ohmeda S/5TM E-CAiOVX Module (K051092) and accessories and… | |
| * | K061185 | Datex-Ohmeda S/5 Compact Anesthesia Monitor with L-CANE05A and L-CANE05A SoftwareSummary page 2…RICAiOV, E-MRICAiO, E- MRICO and accessories is substantially equivalent to the predicates D-E MRI Monitor (980651), S/5TM CAM with L-CANE05 and L-CANE05A (K061185), Datex-Ohmeda S/5TM E-CAiOVX Module (K051092) and accessories and Datex-Ohmeda S/5T M E-PRESTN Module (KO51217) and… | 2006 |
| * | K051092 | Datex-Ohmeda S/5 Compact Airway Module (Model Family E-Caiovx) E-Caiovx, E-Caiov…Summary page 2…s substantially equivalent to the predicates D-E MRI Monitor (980651), S/5TM CAM with L-CANE05 and L-CANE05A (K061185), Datex-Ohmeda S/5TM E-CAiOVX Module (K051092) and accessories and Datex-Ohmeda S/5T M E-PRESTN Module (KO51217) and accessories. DEVICE DESCRIPTION as required by 80… | 2005 |
| * | K051217 | Datex-Ohmeda Prestin Module (Model Family E-Prestin, Including E-Prestin, E-Restin…Summary page 4…h is modified from the F-CM I S/5 Compact Anesthesia Frame (K061185). The MR Monitor with N- PSNGV option utilizes the technology of the Datex-Ohmeda E-PRESTN (K051217) modules. The MR Monitor with E-MRICAiOVX option utilizes the technology of the Datex-Ohmeda E- CAiOVX (K051092) module… | 2006 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 6 years and passes through 3 companies; a new generation was cleared every 1.8 years on median.
- 1 of the 8 ancestors has a recall of any class.
- 1 other device also cites its predicate K061185.
How does its category compare?
All MHX devicesMHX Monitor, Physiological, Patient (With Arrhythmia Detection Or Alarms): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MHX
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MHX
192in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MHX
21so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MHX
3,761in 2025
MAUDE reports naming product code MHX, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 15 | 96 | 3 | 131 |
| 2008 | 16 | 58 | 2 | 232 |
| 2009 | 13 | 57 | 7 | 382 |
| 2010 | 20 | 90 | 13 | 955 |
| 2011 | 12 | 81 | 16 | 949 |
| 2012 | 16 | 88 | 11 | 676 |
| 2013 | 21 | 120 | 14 | 1,997 |
| 2014 | 13 | 248 | 6 | 1,609 |
| 2015 | 14 | 203 | 5 | 1,284 |
| 2016 | 13 | 149 | 7 | 1,105 |
| 2017 | 14 | 134 | 6 | 1,115 |
| 2018 | 11 | 203 | 12 | 2,157 |
| 2019 | 7 | 243 | 6 | 1,462 |
| 2020 | 11 | 196 | 0 | 1,714 |
| 2021 | 5 | 195 | 0 | 2,423 |
| 2022 | 15 | 189 | 6 | 1,470 |
| 2023 | 8 | 229 | 3 | 2,254 |
| 2024 | 5 | 181 | 3 | 2,814 |
| 2025 | 8 | 192 | 15 | 3,761 |
| 2026 | 14 | 205 | 21 | — |
What is it indicated for?
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…
Read the full statement (211 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062324 · printed Nov 6, 2026
Cite this page
510(k) Report. “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.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K062324
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026