CNS-2101 Central Monitor

K223567 · Nihon Kohden Corporation · MSX · Jul 31, 2023 · Cardiovascular

Device Facts

• Record ID: K223567
• Device Name: CNS-2101 Central Monitor
• Applicant: Nihon Kohden Corporation
• Product Code: MSX · Cardiovascular
• Decision Date: Jul 31, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2300
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The CNS-2101 central monitor is a networked multi-patient monitoring system, that is intended to display, record and print monitored physiological data from Nihon Kohden bedside monitors, telemetry receiver and/or transmitters. The CNS-2101 does not perform any data processing on the Nihon Kohden compatible devices. When the CNS-2101 is to connect with the Nihon Kohden bedside monitors and telemetry receivers/transmitters the CNS-2101 can: - Admit and discharge patients on the Nihon Kohden network. - Display and manage compatible devices' real-time patient clinical data. - Mimic the alarms of connected devices when a measured parameter falls outside a preset limits or when an arrhythmia is detected. - Review and trend data calculated by connected Nihon Kohden devices. - Store and transfer historical clinical data for the connected systems. - Print patient data. The CNS-2101 is intended for use in professional medical facilities by trained medical personnel.

Device Story

CNS-2101 is a networked central monitoring system for professional medical facilities; operated by trained personnel at locations like nurse stations. It receives real-time physiological data (ECG, pulse rate, etc.) from connected Nihon Kohden bedside monitors and telemetry transmitters via the NET-9/LS-NET network. The device displays, records, and prints this data; it mimics alarms from connected devices when parameters exceed limits or arrhythmias are detected. It also stores and trends historical clinical data. The device does not perform primary data processing on the received signals; it acts as a central hub for managing patient data and alarms across multiple connected monitors. Benefits include centralized patient oversight, enabling clinicians to monitor multiple patients simultaneously and respond to alarms efficiently. It features an integrated 23.8-inch LCD display, touchscreen, keyboard, and mouse, with an internal battery for short-term power backup.

Clinical Evidence

No clinical data. Bench testing only. Verification and validation performed per FDA-recognized consensus standards including IEC 60601-1 (safety), IEC 60601-1-8 (alarms), IEC 60601-2-27 (ECG monitoring), and IEC 62304 (software lifecycle). Testing confirmed robust network communication and stable exchange of physiological data between the CNS-2101 and compatible Nihon Kohden monitors.

Technological Characteristics

Integrated PC/LCD display (23.8-inch, 1920x1080); AC power with internal 3-minute battery backup; 480 GB SSD storage; 5 USB ports with lockout. Connectivity via NET-9/LS-NET. Software runs on Microsoft Windows 10 IoT (Embedded). Compliant with IEC 60601-1:2005+A1:2012 and IEC 60601-1-8:2012. Cybersecurity features include USB port lockout.

Indications for Use

Indicated for professional medical facilities to display, record, and print physiological data from Nihon Kohden bedside monitors, telemetry receivers, and transmitters for adult and pediatric patients.

Regulatory Classification

Identification

A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.

Predicate Devices

• BeneVision Central Monitoring System (K193391)

Reference Devices

• Life Scope BSM-1700 Series Bedside Monitor (K220976)
• Life Scope BSM-6000 Bedside Monitoring System (K213316)
• Life Scope BSM-3000 Bedside Monitor (K213316)
• Life Scope CSM-1901 Bedside Monitoring System (K213316)
• Life Scope G5 Bedside Monitoring System (K203435)
• Life Scope G7 Bedside Monitoring System (K203435)
• Nihon Kohden CNS-6200 Series CNS Model-6201/6801 (K102376)
• Nihon Kohden SVM-7200 series Vital Signs Monitor (K190468)
• Nihon Kohden Vital Sign Telemeter GZ-140P (K163459)
• Nihon Kohden Vital Sign Telemeter, GZ-120P/GZ-130P (K153707)
• Transmitter ZS-940PA Series, ZM 520/521/530/531 (K043517)
• Multiple Patient Receiver, Model ORG-9700/9100A (K071058)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

July 31, 2023

Nihon Kohden Corporation % Sandra Gadeyne Sr. Director, Quality and Regulatory Affairs Nihon Kohden America 15353 Barranca Pkwy Irvine, California 92618

Re: K223567

Trade/Device Name: CNS-2101 Central Monitor Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (Including Cardiotachometer And Rate Alarm) Regulatory Class: Class II Product Code: MSX, MHX, DRQ, MWI Dated: November 29, 2022 Received: November 29, 2022

Dear Sandra Gadeyne:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies.

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You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatoryinformation/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Shruti N. Mistry -S

for

Jennifer Shih Kozen Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K223567

Device Name

CNS-2101 Central Monitor

The CNS-2101 central monitor is a networked multi-patient monitoring system, that is intended to display, record and print monitored physiological data from Nihon Kohden bedside monitors, telemetry receiver and/or transmitters. The CNS-2101 does not perform any data processing on the Nihon Kohden compatible devices. When the CNS-2101 is to connect with the Nihon Kohden bedside monitors and telemetry receivers/transmitters the CNS-2101 can:

- · Admit and discharge patients on the Nihon Kohden network.
- · Display and manage compatible devices' real-time patient clinical data.
- Mimic the alarms of connected devices when a measured parameter falls outside a preset limits or when an arrhythmia is detected.
- · Review and trend data calculated by connected Nihon Kohden devices.
- · Store and transfer historical clinical data for the connected systems.
- · Print patient data.

The CNS-2101 is intended for use in professional medical facilities by trained medical personnel.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/1 description: The image shows the logo for Nihon Kohden, a Japanese medical equipment manufacturer. The logo consists of a blue square with a white abstract design on the left and the company name "NIHON KOHDEN" in blue, sans-serif font on the right. The abstract design in the square resembles a stylized wave or a rising sun.

### 510(K) SUMMARY GENERAL PROVISIONS 1.

| Table 1 Administrative Information | |
|----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Sponsor | Nihon Kohden Corporation<br>1-31-4 Nishiochiai, Shinjuku-Ku<br>Tokyo, Japan 161-8560 |
| Initial Importer | Nihon Kohden America<br>15353 Barranca Parkway<br>Irvine, CA |
| Company Representative/U.S. Agent | Sandra Gadeyne, MBA, ASQ-CQA<br>Sr. Director, Quality Assurance and Regulatory Assurance<br>15353 Barranca Parkway<br>Irvine, CA<br>Office Phone: [phone]<br>Mobile Phone: [phone]<br>Email: Sandra [e-mail] |
| Official Correspondent/Primary Contact | Hiroko Hagiwara<br>General Manager, Clinical Development and Regulatory Affairs<br>Division, NIHON KOHDEN CORPORATION<br>Office Phone: [phone]<br>Mobile Phone: [phone]<br>Email: Hiroko [e-mail] |

## Table 2 Submission Information

| Submission Type | Traditional 510(k) |
|------------------------------|----------------------------------------------------------------|
| Common Device Name | System, Network and Communication, Physiological Monitor |
| Regulation Medical Specialty | Cardiovascular |
| Classification Panel | Cardiovascular |
| Product Codes | MSX |
| Premarket Review | Cardiovascular Devices (OHT2) |
| | Cardiac Electrophysiology, Diagnostics, and Monitoring Devices |
| | (DHT2A) |
| Regulation Number | 870.2300 |
| Classification | Class II |
| Decision Type | 510(k) |
| Proprietary Name | CNS-2101 Central Monitor |
| Marketing Names | CNS-2101, CNS-2101 Central Monitoring System |
| Submission Basis | New Device; |
| Previous 510(k) Submissions | None |
| Predicates | BeneVision Central Monitoring System (K193391) |
| Date Prepared | November 29, 2022 |

### PRODUCT DESCRIPTIONS 2.

The CNS-2101 central monitor is a central monitoring device designed to support medical personnel to provide medical care to multiple patients at the same time. It acquires vital sign data from multiple

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Traditional 510(k) - CNS-2101 Central Monitor 510(k) Summary

monitoring devices such as bedside monitors and displays the acquired data such as ECG and pulse rate on the screen as well as informing alarms.

The CNS-2101 can communicate with other devices through a network connection. The CNS-2101 can acquire vital sign data directly from multiple monitoring devices (e.g., bedside monitors) connected to Nihon Kohen Monitoring device network or using multiple patient receivers and transmitters, or by a combination of both methods. The parameters to monitor on the central monitor can be changed as necessary by selecting a monitoring device such as a bedside monitor or transmitter and changing the parameter settings for that device.

The CNS-2101 is designed to be installed in a location outside the patient environment such as a nurse's station for central monitoring.

#### 3. INDICATIONS FOR USE/INTENDED USE

The CNS-2101 central monitor is a networked multi-patient monitoring system, that is intended to display, record and print monitored physiological data from the Nihon Kohden bedside monitors, telemetry receiver and/or transmitters.

The CNS-2101 does not perform any data processing on the data received from the Nihon Kohden compatible devices. When the CNS-2101 is to connect with the Nihon Kohden bedside monitors and telemetry receivers/transmitters, the CNS-2101 can:

- . Admit and discharge patients on the Nihon Kohden network.
- o Display and manage compatible devices' real-time patient clinical data.
- . Mimic the alarms of connected devices when a measured parameter falls outside a preset limit or when an arrhythmia is detected.
- . Review and trend data calculated by connected Nihon Kohden devices.
- Store and transfer historical clinical data for the connected systems. ●
- Print patient data.

The CNS-2101 is intended for use in professional medical facilities by trained medical personnel.

#### SUBMISSION SCOPE 4.

Nihon Kohden (NK) is requesting market clearance for the CNS-2101 and accessories. The accessories include software licenses, peripheral devices and networking materials. The CNS-2101 communicates with other NK devices on the NK network (NET-9). The previously cleared devices compatible with the CNS-2101 are provided in Table 3.

| Table 5 NK Compatible Devices | | | |
|--------------------------------------------------|-----------------|------------------|----------------|
| Device name | Product<br>code | 510(k)<br>number | Clearance date |
| Life Scope® BSM-1700 Series Bedside Monitor | MHX | K220976 | July 21, 2022 |
| Life Scope® BSM-6000 Bedside Monitoring System | MHX | K213316 | Dec 29, 2021 |
| Life Scope® BSM-3000 Bedside Monitor | MHX | K213316 | Dec 29, 2021 |
| Life Scope® CSM-1901 Bedside Monitoring System | MHX | K213316 | Dec 29, 2021 |
| Life Scope® G5 Bedside Monitoring System | MHX | K203435 | July 16, 2021 |
| Life Scope® G7 Bedside Monitoring System | MHX | K203435 | July 16, 2021 |
| Nihon Kohden CNS-6200 Series CNS Mode1-6201/6801 | MHX | K102376 | Dec. 7, 2010 |

Table 3 NK Compatible Devices

Nihon Kohden Corporation

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| Device name | Product<br>code | 510(k)<br>number | Clearance date |
|----------------------------------------------------|-----------------|------------------|----------------|
| Nihon Kohden SVM-7200 series Vital Signs Monitor | MWI | K190468 | May 28, 2019 |
| Nihon Kohden Vital Sign Telemeter GZ-140P | MHX/DRG | K163459 | Apr. 4, 2017 |
| Nihon Kohden Vital Sign Telemeter, GZ-120P/GZ-130P | MHX/DRG | K153707 | Sept. 2, 2016 |
| Transmitter ZS-940PA Series, ZM 520/521/530/531 | DRT | K043517 | Feb. 3, 2005 |
| Multiple Patient Receiver, Model ORG-9700/9100A | DRG | K071058 | June 29, 2007 |

### 5. COMPARISON WITH THE PREDICATE DEVICE

### Subject Device Information 5.1

Table 4 provides the regulations that the CNS-2101 is the subject device. with the product code MSX

| Table 4 Regulatory Information on CNS-2101 | | | |
|--------------------------------------------|--------------|-----------------------------------------------------------------|----------------------------------|
| Regulation No | Product code | Device classification | Classification |
| § 870.2300 | MSX | System, Network and<br>Communication, Physiological<br>Monitors | Class II (performance standards) |

# Table 4, Regulatory Information on CNS-2101

### 5.2 Predicate Device Information

Table 5 lists the basic information about the predicate device including 510(k) number, device trade name, 510(k) holder, and clearance date. Regulatory information used for comparison is provided in Table 6.

### Table 5 Predicate Device General Information

| 510(k) product | 510(k) holder | Clearance date |
|---------------------------------------------------|----------------------------------------------------------|----------------|
| BeneVision Central<br>Monitoring System (K193391) | Shenzhen Mindray<br>Bio-medical<br>Electronics Co., LTD. | 22 April, 2020 |

### Table 6 Predicate Device Regulatory Information

| Regulation No | Product code | Device classification | Classification |
|---------------|--------------|-----------------------------------------------------------------|-------------------------------------|
| §870.2300 | MSX | System, Network and<br>Communication,<br>Physiological Monitors | Class II<br>(performance standards) |

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### Comparison Table 5.3

| Table 7 Comparison Table of CNS-2101 Central Monitor and its Predicate |
|------------------------------------------------------------------------|
|------------------------------------------------------------------------|

| Characteristics | CNS-2101 Central Monitor<br>(Proposed device) | BeneVision Central Monitoring System<br>(Predicate Device: K193391) | Comparison |
|-------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Regulation items | | | |
| Classification Panel | Cardiovascular | Cardiovascular | Same |
| Device Name | System, Network And Communication,<br>Physiological Monitors | System, Network And Communication,<br>Physiological Monitors | Same |
| Regulatory Class | Class II (performance standards) | Class II (performance standards) | Same |
| Regulatory Number | 21CFR 870.2300- Cardiac monitor (including<br>cardiotachometer and rate alarm) | 21CFR 870.2300 -Cardiac monitor (including<br>cardiotachometer and rate alarm) | Same |
| Product Code | Primary Product Codes:<br>MSX - System, network and<br>communication, physiological monitors<br><br>Subsequent Product Codes:<br>MHX- Monitor, physiological, patient<br>(with<br>arrhythmia detection or alarms)<br>DRQ- Amplifier and signal<br>conditioner, transducer signal<br>MWI- Monitor, Physiological, Patient<br>(Without Arrhythmia Detection<br>Or Alarms) | Primary Product Codes:<br>MSX - System, network and communication,<br>physiological monitors<br><br>Subsequent Product Codes:<br>DRQ- amplifier and signal conditioner,<br>transducer signal<br>MHX- monitor, physiological, patient<br>(with<br>arrhythmia detection or alarms)<br>DRT- monitor, cardiac (incl.<br>cardiotachometer & rate alarm)<br>DXN- system, measurement, blood<br>pressure, non-invasive<br>DQA- Oximeter<br>DSB- Impedance plethysmograph | Both devices share the same<br>MSX primary code and<br>performance specifications.<br><br>The subsequent<br>(secondary) product codes are<br>related to the type of the devices<br>the CNS-2101 can connect to.<br>The NK systems were cleared<br>with the additional secondary<br>codes. |
| Characteristics | CNS-2101 Central Monitor<br>(Proposed device) | BeneVision Central Monitoring System<br>(Predicate Device: K193391) | Comparison |
| Indications for use | The CNS-2101 central monitor is a networked multi-patient monitoring system, that is intended to display, record and print monitored physiological data from Nihon Kohden bedside monitors, telemetry receiver and/or transmitters. The CNS-2101 does not perform any data processing on the data received from the Nihon Kohden compatible devices. When the CNS-2101 is to connect with the Nihon Kohden bedside monitors and telemetry receivers/transmitters the CNS-2101 can:<br>Admit and discharge patients on the Nihon Kohden network. Display and manage compatible devices' real-time patient clinical data. Mimic the alarms of connected devices when a measured parameter falls outside a preset limits or when an arrhythmia is detected. Review and trend data calculated by connected Nihon Kohden devices. Store and transfer historical clinical data for the connected systems. Print patient data. The CNS-2101 is intended for use in professional medical facilities by trained medical personnel. | The indications for use of the BeneVision Central Monitoring System include: Real time viewing of patient clinical data and alarms Storage and historical review of patient clinical data and alarms Printing of real time and historical patient data Configuration of local settings as well as synchronizing settings across the network to a remote device Transfer of patient clinical data and settings between several CentralStations The BeneVision Central Monitoring System is a networked patient monitoring system intended for use in a fixed location, installed in professional healthcare facilities to provide clinicians remote patient monitoring. The network connections between the various devices can be any combination of Ethernet (Wired), Wireless WIFI (WLAN), and Wireless WMTS. The BeneVision Central Monitoring System supports one or more Mindray compatible physiological monitors and will display, store, print, and transfer information received from the compatible monitors; The BeneVision Central Monitoring System supports bi-directional configuration of the compatible monitors. No data processing is done by the BeneVision Central Monitoring System for data received from compatible monitors. | Same - Both devices are compatible with their commercial monitoring devices. The BeneVision includes additional devices; the NK's systems are cleared under a separate 510(k) and is equivalent in terms of functions. |
| Characteristics | CNS-2101 Central Monitor<br>(Proposed device) | BeneVision Central Monitoring System<br>(Predicate Device: K193391) | Comparison |
| | | The telemetry monitoring systems are designed to<br>acquire and monitor physiological data for<br>ambulating patients within a defined coverage<br>area. The BeneVision Central Monitoring System<br>supports Telemetry Systems: TMS-6016,<br>Telepack-608, TMS60, TM80, and TM70.<br>The TMS-6016 transmitter is intended for<br>use on Adult and Pediatric patients to<br>monitor ECG and SpO2 physiological<br>data. The Panorama Telepack-608 transmitter<br>is intended for use on Adult patients to<br>monitor ECG and SpO2 physiological<br>data. The TMS60 transmitter is intended for<br>use on Adult and Pediatric patients over<br>three years old to monitor ECG, SpO2,<br>NIBP and Resp physiological data. The<br>physiological data can be reviewed<br>locally on the display of the transmitter. The CentralStation will support ECG,<br>Heart Rate, SpO2, NIBP, Resp, Pulse<br>Rate, Arrhythmia analysis, QT<br>monitoring, and<br>ST Segment Analysis for the TMS60. The TM80/TM70 telemetry monitor is<br>intended for use on Adult and Pediatric<br>patients over three years old to monitor<br>ECG, SpO2, NIBP and Resp<br>physiological data. The physiological<br>data can be analyzed, alarmed, stored,<br>reviewed locally on the display of the<br>monitor, and the CentralStation can<br>configure and display the physiological<br>parameters from the TM80/TM70. The BeneVision Central Monitoring System is<br>intended for use in professional healthcare<br>facilities under the direct supervision of a licensed<br>healthcare practitioner. | |
| Characteristics | CNS-2101 Central Monitor<br>(Proposed device) | BeneVision Central Monitoring System<br>(Predicate Device: K193391) | Comparison |
| Hardware | | | |
| Display | 1,920×1,080 resolution<br>23.8-inch color TFT type LCD | 1920 x 1080 resolution,<br>19" 16:9 widescreen<br>LCD display, 21.5" and 23" | The BeneVision offers 2 sizes:<br>the CNS-2101 is offered as 1<br>size that is equivalent to the<br>BeneVisions larger size and is an<br>LCD screen. The difference is<br>minor. |
| Operation system | Microsoft Windows 10 IoT<br>(Embedded) | Microsoft Windows 7 Professional<br>Embedded SP1<br>Microsoft Windows 10 | Both devices support the current<br>version of Windows 10. MS is<br>no longer supporting Window 7.<br>The difference does not affect<br>their substantial equivalence. |
| Storage media | 480 GB SSD (Solid State Drive) | 500 GB Hard Disk Drive | Both devices have storage<br>capacity. The difference does not<br>affect their substantial<br>equivalence. |
| Monitor design | PC Integrated main unit and display<br>Into 1 device | PC unit and display are separated | The CNS-2101 has an integrated<br>design. Both devices are<br>compliant with IEC 60601-<br>1:2005+A1:2012. The difference<br>does not affect their substantial<br>equivalence. |
| USB ports | 5 | 2 | The CNS-2101 has an integrated<br>design. Both devices are<br>compliant with IEC 60601-<br>1:2005+A1:2012. The difference<br>does not affect their substantial<br>equivalence. |
| USB lockout | Yes | Unknown | The additional USB port lockout<br>is a cybersecurity enhancement<br>and does not affect the<br>performance of the device. |
| Audio | Built-in speakers | Built-in speakers | Same |
| Operation Methods | |…