READY View is an image analysis software that allows the user to process dynamic or functional volumetric data and to generate maps that display changes in image intensity over time, echo time, b-value (Diffusion imaging) and frequency (Spectroscopy). The combination of acquired images, reconstructed images, calculated parametric images, tissue segmentation, annotations and measurement performed by the clinician allows multiparametric analysis and may provide clinically relevant information for diagnosis.

Device Description

READY VIEW (K110573) is a suite of applications developed to improve multi-parametric exams by enobling the analysis of MR generated data sets containing multiple images for each scan location. The MR data sets may be any of the following:

A time series
A diffusion weighted scan
A diffusion tensor scan
A variable echo imaging
A blood oxygen level dependent imaging
Spectroscopy (Single voxel and 2D or 3D CSI)
The READY View platform provides a combination of protocols, applications and tools that enables a fast, easy and quantified analysis of the multiple data sets.
Brain View is a post processing image analysis software package that provides advanced techniques to aid in the diagnosis of neurological and oncological diseases. Brain View is an option with the READY View platform and offers two advanced protocols:
FiberTrak
Arterial Spin Labeling (ASL)
READY View along with Brain View option are available on the Advantage Workstation (AW), Advantage Workstation Server Gen 2 and AW Server PACS, for viewing and processing Magnetic Resonance images.
The basis for this submission is a modification of a legally marketed device to incorporate additional features. The following additional functional protocols can now be post processed using READY View software:
Brain View which is a post processing image analysis software package that provides advanced techniques to aid in the diagnosis of neurological and oncological diseases now offers two additional advanced protocols :
BrainStat
BrainStat AIF
Body View is a post processing image analysis software package that provides advanced techniques to aid in the diagnosis of oncological diseases in the human body. Body View is an option : with the READY View platform and offers two advanced protocols:
Signal Enhancement Ratio (SER)
MR Standard
READY View along with Brain View and Body View options are available on the Advantage Workstation (AW), Advantage Workstation Server Gen 2 and AW Server PACS, for viewing and processing Magnetic Resonance images.

AI/ML Overview

The provided 510(k) submission for GE Healthcare's READY View states that no clinical studies were required to support substantial equivalence for this device. Therefore, there is no information available in this document regarding acceptance criteria, device performance, sample sizes, expert involvement, or ground truth establishment based on clinical data.

The submission focuses entirely on non-clinical tests to demonstrate substantial equivalence to its predicate device (READY View K110573).

Here's a breakdown of what the document does state regarding testing:

1. A table of acceptance criteria and the reported device performance

Not Applicable. The document explicitly states: "The subject of this premarket submission, READY View, did not require clinical studies to support substantial equivalence." Therefore, no clinical performance metrics or acceptance criteria based on patient outcomes are provided.
The "Summary of Non-Clinical Tests" lists general quality assurance measures:
- Risk Analysis
- Requirements Reviews
- Design Reviews
- Performance testing (Verification)
- Safety testing (Verification)
- Simulated use testing (Validation)
  However, specific acceptance criteria or detailed results from these non-clinical tests are not disclosed in this summary.

2. Sample sized used for the test set and the data provenance

Not Applicable. No clinical test set. The document states: "All clinical images required for verification and validation activities were obtained from legally marketed GE MR Systems." This indicates that existing images were used for internal testing and validation, but not for a formal clinical study to prove substantial equivalence of the new features. The number of such images is not specified, nor is their provenance (e.g., country of origin, retrospective/prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not Applicable. No clinical test set requiring expert ground truth in the context of this submission.

4. Adjudication method for the test set

Not Applicable. No clinical test set.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not Applicable. No MRMC study was conducted or reported. The device is described as "post processing image analysis software" that "allows multi-parametric analysis and may provide clinically relevant information for diagnosis." There is no mention of AI assistance for human readers or comparative effectiveness in this context.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not Applicable. While the device is "algorithm only" in its function as image analysis software, the submission does not present a standalone performance study in the typical sense of measuring diagnostic accuracy against a ground truth. Its equivalence is based on non-clinical testing and comparison to its predicate device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not Applicable. For non-clinical verification and validation activities utilizing "clinical images," the type of ground truth used to assess the software's processing capabilities (e.g., whether it correctly generates maps or graphs based on its algorithms) is not specified. It's likely that the "ground truth" for these internal tests was the expected output of the algorithms given the input data, verified by engineers or subject matter experts against predefined specifications, rather than clinical ground truth (like pathology or expert consensus on diagnosis).

8. The sample size for the training set

Not Applicable. There is no mention of machine learning or AI training sets in this submission. The device description focuses on its function as "post processing image analysis software" that applies protocols and tools for analysis, not on learning from data.

9. How the ground truth for the training set was established

Not Applicable. As no training set is mentioned, this question is not relevant to the provided text.

In summary, the 510(k) submission for READY View (K113456) explicitly states that clinical studies were not required to demonstrate substantial equivalence for the modifications introduced (new protocols like BrainStat, BrainStat AIF, SER, MR Standard). The reliance was on non-clinical software verification and validation activities.

Summary

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JUN 1 5 2012

GE Healthcare 510(k) Premarket Notification Submission

510(k) Summary

In accordance with 21 CFR 807.92 the following summary of information is provided:

Date: November 18th, 2011

Submitter: GE Healthcare (GE Medical Systems SCS)

Establishment Registration Number - 9611343 283, Rue de la Minière 78530 Buc, France

Primary Contact Person:

Elizabeth Mathew Regulatory Affairs Leader GE.Healthcare, (GE Medical Systems, LLC) 3114 N. Grandview Blvd., Mail Stop: W-501 Waukesha, WI - 53188, USA Phone: (262) 424-7774 Fax: (262) 364-2785

Secondary Contact Person:

Glen Sabin Regulatory Affairs Director - MR GE Healthcare, (GE Medical Systems, LLC) Establishment Reaistration Number - 2183553 3200 N Grandview Blvd., Mail Stop: W-827 Waukesha, WI - 53188, USA Phone: (262) 521-6848

Fax: (262) 364-2785

Device: Trade Name: READY View

Common/Usual Name: READY View

21 CFR 892.2050 Picture archiving and communication system Classification Names:

90 LLZ Product Code:

· Predicate Device: READY View (K110573)

Device Description:

READY VIEW (K110573) is a suite of applications developed to improve multi-parametric exams by enobling the analysis of MR generated data sets containing multiple images for each scan

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p2/4

GE Healthcare 510(k) Premarket Notification Submission

location. The MR data sets may be any of the following:

. A time series
A diffusion weighted scan .
A diffusion tensor scan .
A variable echo imaging .
A blood oxygen level dependent imaging .
Spectroscopy (Single voxel and 2D or 3D CSI) .

The READY View platform provides a combination of protocols, applications and tools that enables a fast, easy and quantified analysis of the multiple data sets.

Brain View is a post processing image analysis software package that provides advanced techniques to aid in the diagnosis of neurological and oncological diseases. Brain View is an option with the READY View platform and offers two advanced protocols:

FiberTrak .
Arterial Spin Labeling (ASL) .

READY View along with Brain View option are available on the Advantage Workstation (AW), Advantage Workstation Server Gen 2 and AW Server PACS, for viewing and processing Magnetic Resonance images.

The basis for this submission is a modification of a legally marketed device to incorporate additional features. The following additional functional protocols can now be post processed using READY View software:

Brain View which is a post processing image analysis software package that provides advanced techniques to aid in the diagnosis of neurological and oncological diseases now offers two additional advanced protocols :

BrainStat .
BrainStat AIF

Body View is a post processing image analysis software package that provides advanced techniques to aid in the diagnosis of oncological diseases in the human body. Body View is an option : with the READY View platform and offers two advanced protocols:

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Image /page/2/Picture/0 description: The image shows the text "K113456 p 3/4". The text appears to be handwritten, with a slightly uneven and bold font. The numbers are clearly visible, and the letters are distinct. The text is arranged in two lines, with the first line containing the alphanumeric code and the second line containing the letter "p" followed by a fraction.

GE Healthcare 510(k) Premarket Notification Submission

Signal Enhancement Ratio (SER)
MR Standard .

READY View along with Brain View and Body View options are available on the Advantage Workstation (AW), Advantage Workstation Server Gen 2 and AW Server PACS, for viewing and processing Magnetic Resonance images.

Intended Use:

READY View is a image analysis software that allows the user to process dynamic or functional volumetric data and to generate maps that display changes in image intensity over time, echo time, b-value (Diffusion imaging) and frequency (Spectroscopy). The combination of acquired images, reconstructed images, calculated parametric images, tissue segmentation, annotations and measurement performed by the clinician allows multi-parametric analysis and may provide clinically relevant information for diagnosis.

READY View (K110573) is a post-processing application processing MR functional data of the human body acquired from a MR Scanner. Targeted onatomy includes but is not limited to Brain, Breast, Prostate, and Liver.

Functional data sets contain a series of sequentially ordered images for each scan location, where the interval between images can represent time, b-value, echo time, gradient orientation or ppm value (frequency) depending on the data set.

The pixel value in an area of interest at a given scan location may have a different value for each image. To analyze these changes in pixel values, READY View provides two tools:

. Graphs: the pixel values at a given pixel location are plotted as a graph. The graphs can then be represented by the pixel value over the image number or the pixel value over time, bvalue, echo time, gradient orientation or ppm value.
Functional images: for each pixel location, the pixel values from the images are used to compute a characteristic parameter by means of a function. A functional map is then constructed by displaying the value of the parameter for each pixel location.

READY View provides protocols that enable a fast, easy and quantified analysis of the multiple data sets.

The fundamental scientific technology has not changed as a result of the proposed modifications.

Technology:

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K113456
P$^{4/4}$

GE Healthcare 510(k) Premarket Notification Submission

Determination of Substantial

Equivalence:

Summary of Non-Clinical Tests:

The following quality assurance measures were applied to the development of READY View:

Risk Analysis .
Requirements Reviews .
Design Reviews .
Performance testing (Verification)
Safety testing (Verification)
Simulated use testing (Validation)

Summary of Clinical Tests:

The subject of this premarket submission, READY View, did not require clinical studies to support substantial equivalence. All clinical images required for verification and validation activities were obtained from legally marketed GE MR Systems.

Conclusion:

GE Healthcare considers READY View to be as safe, as effective, and performance is substantially equivalent to the predicate devices.

Image /page/3/Picture/16 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined within a circular border. The design is simple and recognizable, representing the well-known multinational corporation.

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Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the caduceus. The logo is black and white.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002

GE Healthcare (GE Medical Systems SCS) % Ms. Elizabeth Mathew Regulatory Affairs Leader GE Healthcare (GE Medical Systems, LLC) 3114 N Grandview Boulevard WAUKESHA WI 53188

JUN 1 5 2012

Re: K113456

Trade/Device Name: READY View Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: May 25, 2012 Received: May 30, 2012

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.

If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of

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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely Yours,

Janine M. Morris

Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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GE Healthcare 510(k) Premarket Notification Submission

510{k) Number (if known): Device Name:

[INSERT 510(k) NUMBER IF KNOWN] READY View

Indications for Use

Prescription Use X AND/OR (Part 21 CFR 801 Subpart D)

Over-The-Counter Use_ (Part 21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety 56 510(k)

Page 1 of 1

Regulation Number and Section

§ 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).