510(k) · Cleared
Recalled · Class II · 2015Panorama Patient Monitoring Network
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · MHX Monitor, Physiological, Patient (With Arrhythmia Detection Or Alarms)
Cleared on Sep 2, 2015 as substantially equivalent to K142601 (Shenzhen Mindray Bio-Medical Electronics Co., 2014) and 2 other predicates after a 230-day review. Its family tree reaches back 15 generations to 1994. It has been recalled once.
- Decided
- Sep 2, 2015
- Review
- 230 days
- Class
- Class II
- Product code
- MHX
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 15 generations to K941811 (1994). 169 ancestors in all, the oldest K781836 (1978). No later device cites it as a predicate yet.
- Root · 15 generations backK941811 HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co. · 1994
- 11 generations between
- 3 generations backK033513 Easi Ecg AlgorithmPhilips Medical Systems · 2004
- 2 generations backK080461 Star ST and Arrhythmia Software, Release J.0Philips Medical Systems · 2008
- 1 generation backK101521 ST/AR ST and Arrhythmia Software Model: Release K.OPhilips Medical Systems · 2010
- This deviceK150082 Panorama Patient Monitoring NetworkShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2015
Show all 15 generations
- Root · 15 generations backK941811 HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co. · 1994
- 14 generations backK960934 HP M1205A Omnicare Component Monitor System Model 24Hewlett-Packard Co. · 1996
- 13 generations backK981376 Hewlett-Packard M1205A Viridia 24 CTHewlett-Packard Co. · 1999
- 12 generations backK990125 HP Viridia Component Monitoring System, Model Rev. KHewlett-Packard GmbH · 1999
- 11 generations backK990972 HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP…Hewlett-Packard GmbH · 1999
- 10 generations backK013199 Philips Component Compact Monitor,Model M1275B, Philips Compenent…Philips Medical Systems, Inc. · 2001
- 9 generations backK020531 Philips Multi-Parameter Module, Model M3001A; Philips Component…Philips Medical Systems · 2002
- 8 generations backK021778 Philips Component Compact Monitor, Release a.04, Model #M1275BPhilips Medical Systems · 2002
- 7 generations backK023871 M3046A (M2/M3/M4) Compact Portable Patient Monitor and MP60 & MP70…Philips Medical Systems · 2002
- 6 generations backK030038 Philips MP60, MP70 and MP90 Intellivue Patient Monitors with Portal…Philips Medical Systems, Inc. · 2003
- 5 generations backK031481 The Philips Intellivue MP60, MP70, and MP90 Patient Monitors…Philips Medizin Systeme Boblingen GmbH · 2003
- 4 generations backK032858 The Philips Intellivue MP40, MP50, MP60, MP70,and MP90 Patient…Philips Medizin Systeme Boblingen GmbH · 2003
- 3 generations backK033513 Easi Ecg AlgorithmPhilips Medical Systems · 2004
- 2 generations backK080461 Star ST and Arrhythmia Software, Release J.0Philips Medical Systems · 2008
- 1 generation backK101521 ST/AR ST and Arrhythmia Software Model: Release K.OPhilips Medical Systems · 2010
- This deviceK150082 Panorama Patient Monitoring NetworkShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K941811 | HP M1175A, M1176A, Component Monitoring System | Hewlett-Packard Co. | 1994 | — |
| −14 | K960934 | HP M1205A Omnicare Component Monitor System Model 24 | Hewlett-Packard Co. | 1996 | — |
| −13 | K981376 | Hewlett-Packard M1205A Viridia 24 CT | Hewlett-Packard Co. | 1999 | — |
| −12 | K990125 | HP Viridia Component Monitoring System, Model Rev. K | Hewlett-Packard GmbH | 1999 | — |
| −11 | K990972 | HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP Viridia… | Hewlett-Packard GmbH | 1999 | — |
| −10 | K013199 | Philips Component Compact Monitor,Model M1275B, Philips Compenent Rack, Model… | Philips Medical Systems, Inc. | 2001 | — |
| −9 | K020531 | Philips Multi-Parameter Module, Model M3001A; Philips Component Compact… | Philips Medical Systems | 2002 | — |
| −8 | K021778 | Philips Component Compact Monitor, Release a.04, Model #M1275B | Philips Medical Systems | 2002 | — |
| −7 | K023871 | M3046A (M2/M3/M4) Compact Portable Patient Monitor and MP60 & MP70 Intellivue… | Philips Medical Systems | 2002 | — |
| −6 | K030038 | Philips MP60, MP70 and MP90 Intellivue Patient Monitors with Portal Technology… | Philips Medical Systems, Inc. | 2003 | — |
| −5 | K031481 | The Philips Intellivue MP60, MP70, and MP90 Patient Monitors, Release a.20 | Philips Medizin Systeme Boblingen GmbH | 2003 | — |
| −4 | K032858 | The Philips Intellivue MP40, MP50, MP60, MP70,and MP90 Patient Monitors… | Philips Medizin Systeme Boblingen GmbH | 2003 | — |
| −3 | K033513 | Easi Ecg Algorithm | Philips Medical Systems | 2004 | — |
| −2 | K080461 | Star ST and Arrhythmia Software, Release J.0 | Philips Medical Systems | 2008 | — |
| −1 | K101521 | ST/AR ST and Arrhythmia Software Model: Release K.O | Philips Medical Systems | 2010 | — |
| 0 (this device) | K150082 | Panorama Patient Monitoring Network | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1986 | 1 | 0 |
| 1987 | 1 | 0 |
| 1989 | 2 | 0 |
| 1990 | 9 | 0 |
| 1991 | 7 | 0 |
| 1992 | 6 | 0 |
| 1993 | 6 | 0 |
| 1994 | 8 | 0 |
| 1995 | 10 | 0 |
| 1996 | 6 | 0 |
| 1997 | 11 | 0 |
| 1998 | 17 | 0 |
| 1999 | 12 | 0 |
| 2000 | 16 | 0 |
| 2001 | 6 | 0 |
| 2002 | 15 | 0 |
| 2003 | 7 | 0 |
| 2004 | 3 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 3 | 0 |
| 2014 | 2 | 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? (3)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K142601 | Panorama Patient Monitoring NetworkSummary page 6…cardiotachometer and monitors rate alarm). Predicate Device: Panorama Patient Monitoring Network (K142601) Hypervisor central monitoring system(including telemetry monitoring system,tms-6016) (… | 2014 |
| * | K132036 | Hypervisor Central Monitoring System (Including Telemetry Monitoring System, TMS-6016)Summary page 6…rama Patient Monitoring Network (K142601) Hypervisor central monitoring system(including telemetry monitoring system,tms-6016) (K132036) Philips ST/AR ST and Arrhythmia software (K101521) Indications for Use: The indications for use for the Pan… | 2014 |
| * | K101521 | ST/AR ST and Arrhythmia Software Model: Release K.OSummary page 6…r central monitoring system(including telemetry monitoring system,tms-6016) (K132036) Philips ST/AR ST and Arrhythmia software (K101521) Indications for Use: The indications for use for the Panorama Patient Monitoring Network include: x Viewing real time patient… | 2010 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 15, 2015 | Class II | Z-0701-2016 | Software design | An issue with the Panorama Central Station may cause the system to spontaneously restart. This may occur after about 49 days of continuous operation. On restart, monitoring will be lost for about 2.5 minutes. Settings and configurations… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 21 years and passes through 6 companies; a new generation was cleared every 4 months on median.
- 20 of the 169 ancestors have a recall of any class.
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. 2015, this device’s year, is highlighted.
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 indications for use for the Panorama Patient Monitoring Network include: • Viewing real time patient clinical and demographic data • Graphical and numeric trending of clinical data • Storing and printing of clinical and demographic data • Setting independent alarm limits for data sent by the bedside monitor The clinical data displayed by the Panorama Patient Monitoring Network is obtained from one or more compatible physiological monitors and…
Read the full statement (293 words)
The indications for use for the Panorama Patient Monitoring Network include:
• Viewing real time patient clinical and demographic data
• Graphical and numeric trending of clinical data
• Storing and printing of clinical and demographic data
• Setting independent alarm limits for data sent by the bedside monitor
The clinical data displayed by the Panorama Patient Monitoring Network is obtained from one or more compatible physiological monitors and includes: ECG (Lethal and Non-Lethal Arrhythmia Detection, ST Segment Analysis, QT Analysis and heart rate(HR)), Invasive Blood Pressure (IBP), Non-Invasive Blood Pressure(NIBP), Blood Oxygenation (SpO2), Pulse Rate (PR), Respiration Rate (RESP), Respiration Gases(O2,CO2), Temperature(TEMP), Anesthetic Gases (AG), Cardiac Output(C.O.), Bispectral Index (BIS), and Hemodynamics.
The Panorama Patient Monitoring Network is intended for use in a fixed location, in the healthcare facility setting, as a central viewing station. The Panorama Patient Monitoring Network is not intended to be directly connected to the patient at any time or installed in a patient’s vicinity.
The Panorama Network includes the Panorama Telemetry System which acquires and monitors physiological data for ambulating patients within a defined coverage area. The system processes the physiological data to detect various ECG arrhythmia events and select physiological parameter limit violations. The Panorama Telemetry System is intended for installation in a hospital or clinical environment to provide clinicians with patient physiological data, while allowing for patient mobility.
The physiological parameters monitored through telemetry include ECG (Lethal and Non-Lethal Arrhythmia Detection, ST Segment Analysis, QT Analysis and heart rate(HR)), blood oxygenation (SpO2), Pulse Rate (PR). Received data is calculated at the Panorama Central Station, and can be displayed, trended, stored and printed at the Panorama Central Station.
The Panorama Patient Monitoring Network is intended for use under the direct supervision of a licensed healthcare practitioner.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K150082 · printed Nov 4, 2026
Cite this page
510(k) Report. “K150082: Panorama Patient Monitoring Network.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K150082
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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