Who is the manufacturer of PROView?

GE Medical Systems SCS filed the 510(k) submission for PROView (K193306).

What is the FDA product code for PROView?

LLZ. It is classified under 21 CFR 892.2050 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for PROView?

510(k) clearance (submission type: Traditional).

Does PROView use AI or machine learning?

Yes. PROView (K193306) is flagged as an AI/ML-enabled medical device in the FDA's AI/ML device list.

Who can help prepare an FDA 510(k) submission like PROView?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Can an AI/ML device like PROView get a guaranteed FDA 510(k) clearance?

Yes. Innolitics offers a guaranteed FDA 510(k) clearance engagement for AI/ML Software as a Medical Device — combining engineering and regulatory execution under one agreement with a guaranteed clearance outcome. Eligibility: the device must be an AI/ML Software as a Medical Device (SaMD), and its performance must meet the criteria Innolitics determines during an initial regulatory strategy engagement to be necessary for FDA clearance. See https://innolitics.com/services/end-to-end-samd/ or contact https://innolitics.com/contact.

PROView

K193306 · GE Medical Systems SCS · LLZ · Nov 17, 2020 · Radiology

Device Facts

Record ID	K193306
Device Name	PROView
Applicant	GE Medical Systems SCS
Product Code	LLZ · Radiology
Decision Date	Nov 17, 2020
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.2050
Device Class	Class 2
Attributes	AI/ML, Software as a Medical Device

Intended Use

PROView is a medical diagnostic software that is designed to provide easy processing, analysis, reviewing and communication of 3D reconstructed images and their relationship to originally acquired images from MR Scanning devices. The combination of acquired images, reconstructed images, annotations, and measurements performed by the clinician are intended to provide to the referring physician clinically relevant information that may aid in diagnosis and treatment planning.

Device Story

PROView is MR image analysis software used by clinicians/radiologists to review multi-parametric prostate exams. It takes T2-weighted, DWI, and DCE MR images as input. The device uses a deep learning algorithm to perform automatic 3D segmentation of the prostate gland, allowing for manual adjustment if needed. It calculates prostate volume and PSA density, maps lesions to sectors, and facilitates scoring per PI-RADS v2.1 guidelines. The software generates a comprehensive report containing measurements and images. This output is used by clinicians to aid in diagnosis and treatment planning for patients with known or suspected prostate lesions. The device operates as a clinical workflow tool for prostate cancer assessment.

Clinical Evidence

Bench testing only. No clinical trials were conducted. Validation of the deep learning-based automatic prostate segmentation algorithm was performed using a database of MRI prostate exams representative of clinical scenarios, protocols, and patient demographics. Results confirmed the algorithm met acceptance criteria and improved performance on volume accuracy.

Technological Characteristics

Software-based MR image analysis tool. Features deep learning-based automatic prostate segmentation algorithm for T2-weighted MRI acquisitions. Supports PI-RADS v2.1 reporting. Designed under 21 CFR 820 and ISO 13485 quality systems. Software level of concern is Moderate.

Indications for Use

Indicated for clinicians, radiologists, or physicians to review multi-parametric prostate MR images following PI-RADS guidelines. Used for assessment of prostate gland volume and findings analysis in male patients with known or suspected prostate lesions. Measurements and scoring are included in a report for referring physicians.

Regulatory Classification

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.

Special Controls

*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).

Predicate Devices

DynaCAD (K192200)

Related Devices

K233196 — Medihub Prostate · JLK, Inc. · Jun 21, 2024
K202501 — Quantib Prostate · Quantib B.V. · Oct 11, 2020
K252608 — AI-Rad Companion Prostate MR · Siemens Healthcare GmbH · Sep 9, 2025
K221106 — Quantib Prostate · Quantib B.V. · May 13, 2022
K241770 — Prostate MR AI (VA10A) · Siemens Healthcare GmbH · Mar 5, 2025

Submission Summary (Full Text)

{0}------------------------------------------------ November 17, 2020 Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left side of the logo is the seal of the Department of Health & Human Services. To the right of the seal is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font size below the words "U.S. FOOD & DRUG". GE Medical Systems SCS % Hong Cui Regulatory Affairs Director 3000 North Grandview Boulevard-HQ WAUKESHA WI 53188 Re: K193306 Trade/Device Name: PROView Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: LLZ Dated: October 21, 2020 Received: October 22, 2020 Dear Hong Cui: 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/cfpmp/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. 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 {1}------------------------------------------------ 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 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 medical devices and radiation-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, For Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K193306 Device Name PROView #### Indications for Use (Describe) PROView is an aiding tool for the clinicians to review multi-parametric resonance (MR) inages following PI-RADS guidelines. It displays acquired and reformatted data for visualization and provides tools for assessment of the prostate gland volume and findings analysis in patients with known or suspected prostate lesions. Measurements and associated scoring are included in a report for communication to referring physicians. It is intended for use by professionals, such as clinicians, radiologists, or physicians. The clinician remains ultinately responsible for the final assessment and diagnosis based on state-of-the-art practices, clinical judgment and interpretation of prostate images or quantitative data. | 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) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the logo for General Electric (GE). The logo is a blue circle with the letters "GE" in a stylized font in the center. There are three small white curved lines around the outside of the circle, evenly spaced. The logo is simple and recognizable. GE Healthcare 510(k) Premarket Notification Submission K193306 ### 510(k) Summary In accordance with 21 CFR 807.92 the following summary of information is provided: | Date: | November 26, 2019 | |----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Submitter: | GE Medical Systems SCS | | | Establishment Registration Number - 9611343 | | | 283 rue de la Miniere | | | 78530 Buc, France | | Primary Contact Person: | Hong Cui Regulatory Affairs Director GE Healthcare, (GE Medical Systems, LLC) 3000 N Grandview Blvd., Waukesha, WI - 53188 Phone: (262) 506-8238 Email: hong.cui@ge.com | | Secondary Contact Person: | Elizabeth Mathew Senior Regulatory Affairs Manager Phone: (262) 424-7774 Email: Elizabeth.Mathew@ge.com | | Proposed Device: | | | Device Name: | PROView | | Common/Usual Name: | MR image analysis software | | Regulation number/ Product Code: | 21 CFR 892.2050 Picture archiving and communications system/ LLZ | Classification: Class II {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" intertwined in a stylized script, enclosed within a blue circle. There are four stylized water droplets or flourishes evenly spaced around the perimeter of the circle, adding a decorative element to the design. ## GE Healthcare 510(k) Premarket Notification Submission Predicate Device: | Device Name: | DynaCAD | |-------------------------------------|---------------------------------------------------------------------| | 510(k) number: | K192200 cleared on Oct 9, 2019 | | Regulation number/ Product Code: | 21 CFR 892.2050 Picture archiving and communication system / LLZ | | Classification: | Class II | | Manufacturer: | Invivo Corporation, USA | ### Device Description/ Technology: PROView offers a guided workflow for the review, assessment and reporting of multi-parametric MR prostate exams. From inputting clinical information, measuring prostate and lesion volume to scoring lesions to form a comprehensive MR report, PROView offers a simple workflow per PI-RADS™ v2.1 guideline. PROView Processes data from a single date. The PROView workflow includes: - Prostate volume extracted from automatic organ segmentation - PSA Density - Lesion(s) mapping to sectors and measurement ● - Scoring of T2-weighted, diffusion weighted imaging (DWI) and, when ● applicable, dynamic contrast enhanced (DCE) acquisitions. - Automatically generated report with all measurements and images ● Prostate volume can be automatically calculated by defining the contours of the prostate gland with the use of a deep learning algorithm, or through a manual method. Users can cancel or switch to manual prostate gland volume definition if the automatic prostate gland segmentation fails or provides unsatisfactory results #### Intended Use: PROView is a medical diagnostic software that is designed to provide easy processing, analysis, reviewing and communication of 3D reconstructed images and their relationship to originally acquired images from MR Scanning devices. The combination of acquired images, reconstructed images, annotations, and measurements performed by the clinician are intended to provide to the referring physician clinically relevant information that may aid in diagnosis and treatment planning. {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' in a stylized, cursive font, enclosed within a blue circle. There are decorative, wave-like elements surrounding the circle, giving the logo a classic and recognizable appearance. ## GE Healthcare 510(k) Premarket Notification Submission Indication for Use: PROView is an aiding tool for the clinicians to review multi-parametric prostate magnetic resonance (MR) images following PI-RADS guidelines. It displays acquired and reformatted data for visualization and provides tools for assessment of the prostate gland volume and findings analysis in patients with known or suspected prostate lesions. Measurements and associated scoring are included in a report for communication to referring physicians. It is intended for use by professionals, such as clinicians, radiologists, or physicians. The clinician remains ultimately responsible for the final assessment and diagnosis based on state-of-the-art practices, clinical judgment and interpretation of prostate images or quantitative data. Technological Characteristic: The goal of the new PROView software algorithm is to provide an automatic segmentation of the prostate on MRI T2 weighted acquisitions. It is a routine anatomical acquisition (as opposed to functional MRI), routinely done by the clinicians for prostate cancer assessment, as it is part of PIRADS guidelines. The algorithm provides a fully automatic segmentation of the prostate, based on a deep learning model. Comparison: The below comparison identifies the similarities and differences of the proposed PROView to the DynaCAD Prostate module of the predicate device DynaCAD (K192200) to which substantial equivalency is claimed.: | Specification | DynaCAD K192200 (DynaCAD Prostaet) | Proposed Device: PROView | |--------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Targeted clinical condition | Male patient with suspected or known prostate lesions | Male patient with suspected or known prostate lesions | | Anatomy | Prostate | Prostate | | Imaging modality | MRI | MRI | | Gland segmentation | Automatically performs a 3D segmentation of the gland. Users can alter or make adjustments to the segmented results in all three planes. The resulting segmentation reports overall gland volume and sets the stage for UroNav MR/US guided fusion | The software provides a fully automatic segmentation of the prostate, based on a deep learning model. Contour of the prostate gland can be adjusted by the user. Prostate volume is extracted from automatic gland segmentation. | {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' in a stylized, cursive font, enclosed within a blue circle. There are three water droplet shapes surrounding the circle. The logo is simple and recognizable, representing the company's brand identity. # GE Healthcare 510(k) Premarket Notification Submission | | biopsy | | |--------------------------------|------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------| | Gland volume | The resulting segmentation reports overall gland volume and sets the stage for UroNav MR/US guided fusion biopsy | Prostate volume is extracted from automatic gland segmentation after validation of the contour by the user. | | Segmentation algorithm type | Model-based automatic prostate gland segmentation | Automatic segmentation of the prostate based on a deep learning model. | | Standardized report | Following PI-RADS™ v2 | Following PI-RADS™ v2.1 | ### Determination of Substantial Equivalence: PROView has successfully completed the required design control testing per GE's quality system. PROView was designed and will be manufactured under the Quality System Regulations of 21CFR 820 and ISO 13485. The following quality assurance measures have been applied to the development of the device: - Risk Analysis ● - . Requirements Reviews - Design Reviews ● - Performance testing (Verification) ● - Safety testing (Verification) - Algorithm Qualification (Validation) ● Engineering has validated PROView algorithm's capability of automatic segmentation based on deep learning technique by using a database of MRI prostate exams. This database of exams is considered as representative of the clinical scenarios where PROView is intended to be used, with consideration of the different protocols, practices and ethnics factors. The results and feedback concluded that the algorithm meets the acceptance criteria and improves performance on volume accuracy. The substantial equivalence was also based on software documentation for a "Moderate" level of concern device. #### Conclusion: GE Healthcare considers PROView to be as safe, as effective, and performance is substantially equivalent to the predicate device.