(55 days)
Not Found
No
The description focuses on remote access and guidance, with no mention of AI/ML terms or functionalities like image analysis, pattern recognition, or automated decision-making.
No
The device provides remote access for viewing/review of images and real-time guidance to technologists. It explicitly states that "Images reviewed remotely are not for diagnostic use" and its purpose is for training, procedure assessment, and scanning parameter management. It does not directly provide therapy.
No
The "Intended Use / Indications for Use" and "Device Description" sections explicitly state: "Images reviewed remotely are not for diagnostic use." This clearly indicates it is not a diagnostic device.
Yes
The device is described as a "customer facing software application" that provides remote access and guidance. The description focuses solely on the software's functionality and its interaction with existing GE Healthcare medical imaging devices, without mentioning any new or integrated hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples such as blood, urine, or tissue that have been taken from the human body to detect diseases or other conditions.
- Device Function: The Customer Remote Console Software Option is described as providing remote access for viewing/review of images and providing real-time guidance to technologists operating medical imaging devices. It explicitly states that "Images reviewed remotely are not for diagnostic use."
- Intended Use: The intended use is focused on remote access for viewing/review of images and providing guidance, primarily in the context of training, procedure assessment, and scanning parameter management.
- No Biological Samples: The device does not interact with or analyze biological samples from the human body.
Therefore, the function and intended use of this software clearly fall outside the scope of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Customer Remote Console Software Option allows remote access for viewing/review of images as well as the ability to remotely provide real time guidance to the technologist operating GE Healthcare medical imaging devices. This access must be granted by the 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.
Product codes (comma separated list FDA assigned to the subject device)
LLZ
Device Description
Customer Remote Console (CRC) is a customer facing software application that is fully contained within a hospital provider network. It provides remote access for viewing/review of images as well as the ability to remotely provide real time quidance to the technologist operating the GE Healthcare medical imaging devices in the context of training. procedure assessment, and scanning parameter management. Remote users will be able to log into a GEHC imaging medical device from a device (Laptop/Desktop) which meets minimum required specifications anywhere within the provider network. This allows users to spread imaging knowledge and expertise without limitation of time or distance. This access must be aranted by the technologist operating the system and it can also be revoked at any time by the technologist. While a remote session is taking place, the technologist operating the system will have complete control of the session at all times. Also, each remote session will be controlled via a secure credential that is managed by the technologist operating the system. Connections to a medical device are limited to one remote session at a time to maintain strict control over who is remotely interacting with the system. Images reviewed remotely are not for diagnostic use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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, sample size, AUC, MRMC, standalone performance, key results)
Summary of Non-Clinical Tests: Determination of Substantial Equivalence: The following quality assurance measures were applied to the development of CRC:
- Risk Analysis
- . Requirements Reviews
- Design Reviews
- Performance/Safety testing (Verification) .
- . Clinical Scenarios testing (Validation)
Summary of Clinical Tests: The subject of this premarket submission, CRC, does not require clinical studies to support substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of three human profiles facing to the right, with flowing lines connecting them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 24, 2015
GE Medical Systems, LLC % Ms. Elizabeth Mathew Regulatory Affairs Manager GE Healthcare 9900 Innovation Drive WAUWATOSA WI 53226
Re: K150193
Trade/Device Name: Customer Remote Console (CRC) Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: January 28, 2015 Received: January 30, 2015
Dear Ms. Mathew:
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. 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. 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Robert A Ochs
Robert Ochs. Ph.D. Acting Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
Device Name Customer Remote Console (CRC)
Indications for Use (Describe)
The Customer Remote Console Software Option allows remote access for viewing/review of images as well as the ability to remotely provide real time guidance to the technologist operating GE Healthcare medical imaging devices. This access must be granted by the 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.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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3
Section 5: 510(k) Summary
Customer Remote Console (CRC)
Traditional 510(k)
4
510(k) Summary
In accordance with 21 CFR 807.92 the following summary of information is provided:
| Date: | March 20 , 2015 |
|---|---|
| Submitter: | GE Healthcare (GE Medical Systems, LLC) |
| Establishment Registration Number - 2126677 | |
| 3000 N Grandview Blvd., | |
| Waukesha, WI - 53188 | |
| Primary Contact Person: | Elizabeth Mathew |
| Regulatory Affairs Manager | |
| GE Healthcare | |
| 9900 Innovation Drive, | |
| Wauwatosa, WI - 53226 | |
| Mail Stop: RP-2124 | |
| Phone: (262) 521-6658 | |
| Email: Elizabeth.Mathew@ge.com | |
| Secondary Contact Person: | John Jaeckle |
| Chief Regulatory Affairs Strategist | |
| GE Healthcare, (GE Medical Systems, LLC) | |
| 3000 N Grandview Blvd., | |
| Waukesha, WI - 53188 | |
| Phone: 262-424-9547 | |
| Email: John.Jaeckle@ge.com | |
| Device: | |
| Trade Name: | Customer Remote Console |
| Common/Usual Name: | CRC |
| Classification Names: | 21 CFR 892.2050 Picture archiving and communication system |
| Product Code: | 90 LLZ |
| Predicate Device: | MAGNETOM Systems with syngo Expert-i option (K052423) |
| SYNGO EXPERT-I (K061449) | |
| AW Server (K081985) |
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Device Description:
Customer Remote Console (CRC) is a customer facing software application that is fully contained within a hospital provider network. It provides remote access for viewing/review of images as well as the ability to remotely provide real time quidance to the technologist operating the GE Healthcare medical imaging devices in the context of training. procedure assessment, and scanning parameter management. Remote users will be able to log into a GEHC imaging medical device from a device (Laptop/Desktop) which meets minimum required specifications anywhere within the provider network. This allows users to spread imaging knowledge and expertise without limitation of time or distance. This access must be aranted by the technologist operating the system and it can also be revoked at any time by the technologist. While a remote session is taking place, the technologist operating the system will have complete control of the session at all times. Also, each remote session will be controlled via a secure credential that is managed by the technologist operating the system. Connections to a medical device are limited to one remote session at a time to maintain strict control over who is remotely interacting with the system. Images reviewed remotely are not for diagnostic use.
Customer Remote Console Software Option provides remote access Intended Use: for viewing/review of images as well as the ability to remotely provide real time quidance to the technologist operating the scanner. This quidance includes training, procedure assessment, and scanning parameter management.
Indication for Use: The Customer Remote Console Software Option allows remote access for viewing/review of images as well as the ability to remotely provide real time quidance to the technologist operating GE Healthcare medical imaging devices. This access must be granted by the 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.
Summary of Technological Characteristics of the Subject Device as Compared with the Predicate Device:
The proposed device. Customer Remote Console (CRC) employs the same fundamental scientific technology as its predicate devices: MAGNETOM Systems with syngo Expert-i option (K052423), SYNGO EXPERT-I (K061449), AW Server (K081985).
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The Customer Remote Console (CRC) is a software solution that allows remote access for viewing/review of images as well as the ability to remotely provide real time quidance to the technologist operating the GE Healthcare medical imaging devices. Access to imaging devices is controlled through the CRC Server, which controls the connections between imaging devices and CRC Clients. CRC is intended to allow remote users to support technologists for training purposes or for assistance with acquiring images which is the same principle as the MAGNETOM Systems with syngo Expert-i option (K052423) and SYNGO EXPERT-I (K061449). CRC clients can be either inside the customer's local area network (LAN) or outside their LAN, connected to their virtual private network (VPN). The predicates, MAGNETOM Systems with syngo Expert-i option (K052423) and SYNGO EXPERT-I (K061449), also allow remote access to a customer workplace from a PC in the same local area network (LAN). CRC User has to be authenticated before the user can connect to the imaging device. The predicate devices, MAGNETOM Systems with syngo Expert-i option (K052423), SYNGO EXPERT-I (K061449) and AW Server (K081985) also require User Authentication. MAGNETOM Systems with syngo Expert-i option (K052423), SYNGO EXPERT-I (K061449) and the proposed device CRC provides the capability for the customer to select the display quality during a remote session. CRC allows only one remote session with an imaging medical device at a qiven time which is the same principle as the MAGNETOM Systems with syngo Expert-i option (K052423) and SYNGO EXPERT-I (K061449). In the predicate devices (MAGNETOM Systems with syngo Expert-i option (K052423), SYNGO EXPERT-I (K061449)) and proposed device CRC, a remote user does not have access to certain icons on the console of the imaging medical device. In both the predicate devices (MAGNETOM Systems with syngo Expert-i option (K052423) . SYNGO EXPERT-I (K061449)) and proposed device CRC. the technologist operating the scanner and the remote users both have the capability to terminate the remote session.
| Potential Adverse Effects on
Health: | Potential hazards are identified in risk management including
hazard analysis and controlled by: |
| ----------------------------------------- | ----------------------------------------------------------------------------------------------------- |
|---|
- System verification and validation to ensure performance to . specifications and user requirements.
- . Adherence to software development lifecycle procedures ISDLCI
- Instruction for Use provided for the safe and effective use by . users.
7
The device is designed and manufactured under the Quality System Regulations of 21 CFR 820.
Summary of Non-Clinical Tests: Determination of Substantial Equivalence: The following quality assurance measures were applied to the development of CRC:
- Risk Analysis
- . Requirements Reviews
- Design Reviews
- Performance/Safety testing (Verification) .
- . Clinical Scenarios testing (Validation)
Summary of Clinical Tests:
The subject of this premarket submission, CRC, does not require clinical studies to support substantial equivalence.
- GE Healthcare considers CRC to be as safe, as effective, and Conclusion: substantially equivalent to the predicate devices.