(105 days)
No
The summary describes a remote operation and collaboration software for medical imaging devices, focusing on communication, remote access, and control. There is no mention of AI, ML, or any related concepts like image analysis, pattern recognition, or automated decision-making based on data. The description of testing also focuses on functionality and connectivity, not performance metrics typically associated with AI/ML models.
No
Explanation: The device is a software application intended for remote operation, assistance, review, monitoring, and standardization of medical imaging devices, as well as for training medical personnel. It enables remote access and control of modality consoles, facilitating communication and collaboration among healthcare professionals. It does not directly treat or diagnose patients, but rather supports the operation of other medical devices that may be therapeutic or diagnostic.
No
This device is described as a software application for remote operation, assistance, review, monitoring, and standardization of medical imaging devices, and for training medical personnel. It enables remote access and control of modality consoles but does not directly interpret images or provide diagnoses. The "Physician client" mentioned is for a physician to provide "expert radiologist knowledge" but the device itself facilitates the communication, not the diagnostic process.
Yes
The device is described as a "software application" and a "software solution" that provides remote access and control of existing medical imaging and radiotherapeutic devices. While it interacts with hardware (modality consoles, KVM switches), the device itself is the software platform and clients, not the physical hardware it controls or connects through. The description focuses entirely on the software architecture, clients, and functionalities.
Based on the provided information, syngo Virtual Cockpit is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- syngo Virtual Cockpit's Intended Use: The intended use of syngo Virtual Cockpit is for the remote operation, assistance, review, monitoring, and standardization of medical imaging devices and radiotherapeutic devices. It facilitates communication and control of these devices, and also for training personnel.
- No Specimen Analysis: The description does not mention any interaction with or analysis of specimens taken from the human body. Its function is centered around the control and use of imaging and therapeutic equipment.
Therefore, syngo Virtual Cockpit falls under the category of medical devices that support the use of other medical devices, rather than being an IVD itself.
N/A
Intended Use / Indications for Use
syngo Virtual Cockpit is a software application intended for remote operation, assistance, review, monitoring, and standardization of medical imaging devices. It is a vendor neutral solution allowing read-only or full access control to connected devices. syngo Virtual Cockpit is also intended for training of medical personnel working on the medical imaging devices.
Product codes
LLZ
Device Description
This premarket notification addresses the Siemens Healthineers syngo Virtual Cockpit (Version VB10A) Medical Image Management and Processing System (MIMPS).
syngo Virtual Cockpit (sVC) is a software solution for geographically distant technologist or radiologists to remotely assist with operating imaging equipment and radiotherapeutic devices.
sVC provides a private, secure communication platform for real-time image visualization and crossorganizational collaboration between healthcare professionals across multiple sites. sVC enables remote access to modality consoles and enhances communication capabilities between healthcare professionals across different locations. It is vendor-neutral and applicable to existing multimodalities in a healthcare network, a solution that allows healthcare professionals to share expertise and increase productivity, even when they are not physically present in the same location.
sVC is based on a client server architecture, with sVC server as the backbone and 3 different variants of client, based on the user roles, Modality client & Physician client. Modality client as two flavors one windows based client and a web client which can be hosted in a web browser. Steering client establishes remote connection to Modality console / Modality acquisition workplace through KVM (Keyboard, Video and Mouse) switch or Siemens proprietary accessing tool, syngo Expert-i. Steering client can establish connections to more than one (up to 3) Modality console applications. Physician client is the third client for Physician that can be contacted either by Steering technologist or by Modality technologist for assistance regarding scanning in more complex cases, or the Physician can provide expert radiologist knowledge. The connection is possible in full control or read-only mode. The full-control accessibility to CT scanners is limited to the software associated with the modality workplace and is not applicable to the physical switches controlling the equipment operation. The connection to radiotherapeutic equipment is limited to be read-only.
In addition to enabling remote access and control of the modality scanners, sVC also supports common communication methods including live videos at the modality site, audio calls and text chats among users.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Medical imaging devices, Radiotherapeutic devices (linac)
Anatomical Site
No limitation concerning the site of the body the device is intended to be used.
Indicated Patient Age Range
syngo Virtual Cockpit does not have a limitation concerning the patient population (e.g., age, weight, health, condition).
Intended User / Care Setting
syngo Virtual Cockpit is intended for the following user profiles/user roles: Steering Technologist, Modality Technologist, Physician, IT Administrator, Application Specialist, Service Technician, Implementation Engineer, Product Vendor/Business Unit.
Care Setting: Healthcare facilities
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Study Type: Non-clinical testing, Software Verification and Validation.
Sample Size: Not specified.
AUC: Not applicable.
MRMC: Not applicable.
Standalone performance: Not applicable.
Key Results: All performance testing was conducted in a non-clinical fashion as part of the verification and validation activities for the medical device. The features described in this Premarket Notification were supported with verification and validation testing. Software validation is performed using externally sourced representative modality scanners for the entire system in the Siemens Healthineers training center and at the clinical collaborating site. The system configuration, connectivity, compatibility and operation as well as risks associated with clinically relevant functions are assessed to validate the safety and effectiveness of the system in the simulated clinical environment and to validate the appropriateness and implementation of the intended use. Evidence provided within this submission demonstrates conformance with special controls for medical devices containing software. Risk Analysis was completed and risk control implemented to mitigate identified hazards. The testing results support that all the software specifications have met the acceptance criteria. Testing for verification and validation for the device was found acceptable in support to determine similarities to the predicate /previously cleared device. Performance tests were conducted to test the functionality of the device and results were found acceptable.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 21, 2023
Siemens Healthcare GmbH % Prithul Bom Most Responsible Person Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k SAINT PAUL, MN 55114
Re: K232744
Trade/Device Name: syngo Virtual Cockpit (VB10A) Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management And Processing System Regulatory Class: Class II Product Code: LLZ Dated: December 18, 2023 Received: December 18, 2023
Dear Prithul Bom:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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. 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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Lu Jiang
Lu Jiang, Ph.D. Assistant Director Diagnostic X-Ray Systems Team DHT8B: Division of Radiologic Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
2
Indications for Use
Submission Number (if known)
Device Name
syngo Virtual Cockpit (VB10A)
Indications for Use (Describe)
syngo Virtual Cockpit is a software application intended for remote operation, assistance, review, monitoring, and standardization of medical imaging devices. It is a vendor neutral solution allowing read-only or full access control to connected devices. syngo Virtual Cockpit is also intended for training of medical personnel working on the medical imaging devices.
Type of Use (Select one or both, as applicable)
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 Siemens Healthineers. The word "SIEMENS" is written in teal, and the word "Healthineers" is written in orange below it. To the right of the words is a cluster of orange dots.
510(k) Summary syngo Virtual Cockpit (Version VB10A)
In accordance with 21 CFR §807.92, the following summary of safety and effectiveness is provided.
SUBMITTER I.
21CFR § 807.92(a)(1)
Siemens Healthcare GmbH Henkestr. 127 91052 Erlangen Germany
Contact: Dr. Jiayan Liu Phone: +1 (734) 604-7870 Email: jiayan.liu@siemens-healthineers.com
Date Prepared: July 4, 2023
II. DEVICE
21CFR § 807.92(a)(2)
| Device Trade Name | syngo Virtual Cockpit (VB10A) |
|---|---|
| Classification Name | Medical image management and processing system |
| Common Name | System, Image Processing, Radiological |
| Classification Panel | Radiology |
| Regulation Number | §892.2050 Medical image management and processing system |
| Product Code | LLZ |
III. LEGALLY MARKETED PREDICATE DEVICES
21CFR § 807.92(a)(3)
| Predicate Device | |
|---|---|
| Device Trade Name | Customer Remote Console |
| 510(k) Number | K150193 |
| Product Code | LLZ |
| This predicate has not been subject to a design-related recall. |
Reference Device
| Device Trade Name | syngo Expert-i |
|---|---|
| 510(k) Number | K052423 |
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Image /page/4/Picture/0 description: The image shows the logo for Siemens Healthineers. The word "SIEMENS" is written in teal, and the word "Healthineers" is written in orange below it. To the right of the words is a graphic of orange dots arranged in a circular pattern.
Product Code
LNH
This predicate has not been subject to a design-related recall.
IV. DEVICE DESCRIPTION SUMMARY
21CFR § 807.92(a)(4)
This premarket notification addresses the Siemens Healthineers syngo Virtual Cockpit (Version VB10A) Medical Image Management and Processing System (MIMPS).
syngo Virtual Cockpit (sVC) is a software solution for geographically distant technologist or radiologists to remotely assist with operating imaging equipment and radiotherapeutic devices.
sVC provides a private, secure communication platform for real-time image visualization and crossorganizational collaboration between healthcare professionals across multiple sites. sVC enables remote access to modality consoles and enhances communication capabilities between healthcare professionals across different locations. It is vendor-neutral and applicable to existing multimodalities in a healthcare network, a solution that allows healthcare professionals to share expertise and increase productivity, even when they are not physically present in the same location.
sVC is based on a client server architecture, with sVC server as the backbone and 3 different variants of client, based on the user roles, Modality client & Physician client. Modality client as two flavors one windows based client and a web client which can be hosted in a web browser. Steering client establishes remote connection to Modality console / Modality acquisition workplace through KVM (Keyboard, Video and Mouse) switch or Siemens proprietary accessing tool, syngo Expert-i. Steering client can establish connections to more than one (up to 3) Modality console applications. Physician client is the third client for Physician that can be contacted either by Steering technologist or by Modality technologist for assistance regarding scanning in more complex cases, or the Physician can provide expert radiologist knowledge. The connection is possible in full control or read-only mode. The full-control accessibility to CT scanners is limited to the software associated with the modality workplace and is not applicable to the physical switches controlling the equipment operation. The connection to radiotherapeutic equipment is limited to be read-only.
In addition to enabling remote access and control of the modality scanners, sVC also supports common communication methods including live videos at the modality site, audio calls and text chats among users.
V. INTENDED USE/INDICATIONS FOR USE
21CFR § 807.92(a)(5)
Indications for Use Comparison
| Predicate Device
Customer Remote Console
K150193 | Reference Device
syngo Expert-I
K052423 | Subject Device
syngo Virtual Cockpit VB10A |
|--------------------------------------------------------|-----------------------------------------------|-----------------------------------------------|
| The Customer Remote Console | The syngo Expert-i feature | syngo Virtual Cockpit is a |
| Software Option allows remote | allows the local user of the MRI | software application intended for |
| access for viewing/review of | (e.g. tech) to get help and | remote operation, assistance, |
| images as well as the ability to | assistance from other personnel | review, monitoring and |
| remotely provide real time | of the radiology department (e.g. | standardization of medical |
| guidance to the technologist | other tech or physician) to | imaging devices. It is a vendor |
| operating GE Healthcare | perform scans faster and with | neutral solution allowing read- |
| medical imaging devices. This | better quality. For this purpose, a | only or full access control to |
| access must be granted by the | remote user within the local | connected devices. syngo Virtual |
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Image /page/5/Picture/0 description: The image shows the logo for Siemens Healthineers. The word "SIEMENS" is written in teal, and the word "Healthineers" is written in orange. To the right of the word "Healthineers" is a cluster of orange dots.
syngo Virtual Cockpit (Version VB10A) Traditional 510(k) Submission
| technologist operating the
system. The remote access is
only available for systems
supporting GE remote
connectivity capability. Images
reviewed remotely are not for
diagnostic use. | network of the MRI (i.e. the
network of the radiology) can
log onto the MR main or satellite
console. | Cockpit is also intended for
training of medical personnel
working on the medical imaging
devices. |
| --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | ---------------------------------------------------------------------------------------------------------------- | ------------------------------------------------------------------------------------------------------------- |
|---|
The intended use of subject device syngo Virtual Cockpit (version VB10A), predicate device Customer Remote Console and reference device syngo Expert-i is equivalent in that they all enable remote access to medical imaging devices and provide assistance to on-site technologists (Table 2). The subject, predicate and reference devices all allow remote users to help and assist modality technologist to display and review scanning protocols, observe and monitor the image acquisition and therefore help standardize scans in one institution. The intended use of the subject, predicate and reference devices to work with modality scanners is equivalent.
None of the subject, predicate and reference devices is indicated for any specific disease, condition, or patient population, and all are intended to support healthcare professionals in the healthcare institutions' environment. This similarity indicates that they share a broad scope of application and are not intended for a specific subset of patients or clinical scenarios. They can be considered substantially equivalent in their clinical versatility.
Indications for Use/Intended Use Comparison Summary and Conclusion
The Indications for Use were assessed in accordance with the following FDA Guidance Documents:
- The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)] ●
The results of this evaluation determined that the Indications for Use for the subject, device and the predicate device are similar with expanded capability of intended use. As such, Siemens Healthineers is of the opinion that the Intended Use and Indications for Use are similar to the predicate device.
VI. COMPARISON OF FEATURES AND SPECIFICATIONS WITH 21CFR § 807.92(a)(6) THE PREDICATE DEVICE
| Attribute | Predicate Device
Customer Remote Console
K150193 | Reference Device
syngo Expert-i
K052423 | Subject Device
syngo Virtual Cockpit
VB10A | Equivalency
Analysis with
predicate device |
|-------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| General Information | | | | |
| Type of
Software | Software in a Medical Device
(SiMD) | Software in a Medical Device
(SiMD) | Software as a Medical
Device (SaMD) | equivalent |
| Device | System, Image Processing,
Radiological | System, Nuclear Magnetic
Resonance Imaging | System, Image Processing,
Radiological | Identical |
| Regulation | § 892.2050 Medical image
management and processing
system | § 892.1000 Magnetic
resonance diagnostic device | § 892.2050 Medical image
management and processing
system | Identical |
| Product Code | LLZ | LNH | LLZ | Identical |
| Clinical Characteristics | | | | |
| Attribute | Predicate Device
Customer Remote Console
K150193 | Reference Device
syngo Expert-i
K052423 | Subject Device
syngo Virtual Cockpit
VB10A | Equivalency
Analysis with
predicate device |
| Clinical condition
the device is
intended to
diagnose, treat, or
manage | Customer Remote Console is
not indicated for any specific
disease, or condition. | syngo Expert-i is not
indicated for any specific
disease, or condition. | syngo Virtual Cockpit is not
indicated for any specific
disease, or condition. | Identical |
| Intended
patient
population | Customer Remote Console
does not have a limitation
concerning the patient
population (e.g., age, weight,
health, condition). | syngo Expert-i does not have
a limitation concerning the
patient population (e.g., age,
weight, health, condition). | syngo Virtual Cockpit does
not have a limitation
concerning the patient
population (e.g., age, weight,
health, condition). | Identical |
| Site of the body
the device is
intended to be
used | No limitation concerning the
site of the body the device is
intended to be used. | No limitation concerning the
site of the body the device is
intended to be used. | No limitation concerning the
site of the body the device is
intended to be used. | Identical |
| Device Limitations | Not publicly available | syngo Expert-i is not to be
used as the basis for medical
diagnosis.
syngo Expert-i is not to be
used without clinical
personnel at the medical
imaging device who are
trained according to local
laws & regulations.
syngo Expert-i is not suitable
for use in facilities where a
stable and reliable internet
connection is not available. | syngo Virtual Cockpit is not
to be used as the basis for
medical diagnosis.
syngo Virtual Cockpit is not
to be used without clinical
personnel at the medical
imaging device who are
trained according to local
laws & regulations.
syngo Virtual Cockpit is not
suitable for use in facilities
where a stable and reliable
internet connection is not
available.
syngo Virtual Cockpit is not
to be used to connect to
medical devices which
require control of two
monitors when using KVM-
Switches for connecting. | Equivalent to
reference device.
sVC provides a
solution to
connect to
Siemens
Healthineers MR
scanners and
show two screens
in the similar way
as the reference
device. |
| Intended use
environment | Healthcare facilities | Healthcare facilities | Healthcare facilities | Identical |
| Intended user(s) | Radiologist, Expert
Technologist | persons with the certified
specialist knowledge
according to country-specific
regulations, for example,
physicians, trained
radiologists or trained
technologists, after an
appropriate application
training. | syngo Virtual Cockpit is
intended for the following
user profiles/user roles:
Steering Technologist
Modality Technologist
Physician
IT Administrator
Application Specialist
Service Technician
Implementation
Engineer
Product
Vendor/Business Unit | Identical.
Described in
different verbiage
but identical in
contents. |
| Attribute | Predicate Device
Customer Remote Console
K150193 | Reference Device
syngo Expert-i
K052423 | Subject Device
syngo Virtual Cockpit
VB10A | Equivalency
Analysis with
predicate device |
| Technical Characteristics | | | | |
| Supported
radiological
devices | medical imaging devices | • MR | • medical imaging
devices
• Radiotherapeutic devices
(linac), read only | equivalent |
| Supported
vendors | GE | Siemens Healthineers | Vendor neutral | Different. sVC
supports more
vendors. |
| Remote Use | Yes | Yes | Yes | Identical |
| Connectivity
requirements | Secured clinical network | Secured clinical network | Secured clinical network | Identical |
| Accessibility | Read only | Read only and full access | Read only and full access | Identical to
reference device |
| Length of
remote sessions | Not publicly available | Remote session remains
active until manual
disconnections. The
connection automatically
times out after a user defined
idle time. | Remote session remains
active until manual
disconnections. The
connection automatically
times out after a user defined
idle time. | Identical to
reference device |
| User Interface
Functions | PC-based | PC-based | PC-based | Identical |
| Operator
Interface | Keyboard, Mouse, Video | Keyboard, Mouse, Video | Keyboard, Mouse, Video | Identical |
| Delay/latency | Not publicly available | Response time: