(224 days)
No
The document states "Mentions AI, DNN, or ML: Not Found" and describes the device as a display and viewing tool, not one that performs AI-driven analysis or diagnosis.
No
The device is described as a software for viewing and processing medical images for diagnostic and review purposes, not for providing therapy or treatment.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states, "It is intended for use as a diagnostic and review tool by trained healthcare professionals."
Yes
The device is explicitly described as "a software device" and "software only." It runs on "off-the-shelf" hardware (iOS and iPadOS platforms, iPhone 14 Pro Max, iPad Pro 12.9-inch) and its performance validation includes testing of display performance on these commercial devices, indicating the software is the medical device component, not the hardware it runs on.
No
The device is described as software for viewing and processing medical images from various imaging modalities like CT, MRI, and Ultrasound. It does not perform tests on biological samples or body substances, which is a characteristic of IVDs.
N/A
Intended Use / Indications for Use
Horos Mobile is a software device intended for viewing images acquired from computed tomography (CT), computed radiography (CR), magnetic resonance (MR), ultrasound (US) and other DICOM compliant medical imaging systems when installed on suitable commercial standard hardware. Images and data can be stored, communicated, processed, and displayed within the system.
It is intended for use as a diagnostic and review tool by trained healthcare professionals.
This device is not intended to replace full workstations and should be used only when there is no access to a workstation.
This device is not to be used for mammography.
It is the User's responsibility to operate the device in accordance with the software and hardware requirements listed in the instructions for use, in particular ensuring that display quality, ambient light conditions, and image compression ratios are consistent with the clinical application.
Product codes
LLZ
Device Description
The Horos Mobile is an interactive medical image display software device for diagnostic image viewing of radiological images for the following modalities: X-ray, CT, MRI, Ultrasound, and XA for iOS and iPadOS platforms. The technological characteristics and the indications of use are identical to those of the Horos MD™ (K232589). The subject device provides both 2D and 3D image visualization tools for CT and MRI scans from various makes and models of image acquisition hardware. It does not produce any original medical images and does not contain controls for the direct operation of a diagnostic imaging system.
Horos Mobile conforms to the DICOM standard to allow the sharing of medical images with other digital imaging systems such as PACS (Picture Archiving and Communication System).
The Horos Mobile software device runs on the iOS and iPadOS platforms, leveraging of their optimized 3D graphic capabilities, which are provided by the METAL framework developed and maintained by Apple Inc.
The user interface of the software follows Apple's Human Interface Guidelines (HIG) to create a user interface that is intuitive and easy to use for users who are familiar with other Apple products. Typical users of this device are radiologists and clinicians who are familiar with 2D scan images.
Horos Mobile operates on "off-the-shelf" portable hardware devices and is therefore subject to factors not typical for reading room workstations (e.g. screen size, environmental variability, network dependencies, etc.). It is therefore required that the user follows the operating instructions properly and utilizes the risk mitigation features in order to make decisions safely and effectively.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
computed tomography (CT), computed radiography (CR), magnetic resonance (MR), ultrasound (US), X-ray, XA
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained healthcare professionals such as radiologists, clinicians and other qualified physicians. Used as a diagnostic and review tool. This device is not intended to replace full workstations and should be used only when there is no access to a workstation.
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)
Non-Clinical Data
-
Software Verification and Validation Testing
Software verification and validation testing were conducted, and documentation was provided as detailed in FDA's Guidance for Industry and FDA Staff: "Guidance for the content of Premarket Submissions for Software Contained in Medical Devices."
iCat Solutions Ltd has implemented security features for the device and data protection. Cybersecurity requirements, risk analysis, and mitigation was addressed in accordance with FDA guidance Content of Premarket Submission for Management of Cybersecurity in Medical Devices (Oct 2014). -
Bench Performance Testing
The measurement accuracy for the distance (length), angle, point, and area features was validated using automated tests with Digital Reference Objects (DROs) compared against known values. The DROs (n=75 test cases) created were representative of the clinical range typically encountered in radiology practice (1-190 mm). Inter-system error (robustness) and intra-system error (consistency) were assessed using automated processes. -
Display Performance Bench Testing Summary
Bench testing was conducted to evaluate the display performance of the Horos Mobile DICOM Viewer on the iPhone 14 Pro Max and the iPad Pro 12.9-inch. This testing, carried out in accordance with IEC 62563-1, assessed the following key performance characteristics:- Luminance Response Evaluation (DICOM GSDF)
- Luminance Uniformity Evaluation
- Qualitative Image Quality Evaluation, including:
- Greyscale evaluation
- Greyscale (contrast) resolution evaluation
- Contrast evaluation
- Pixel resolution evaluation
- Angular viewing evaluation
This bench testing demonstrated that the designated hardware platforms are appropriate for Horos Mobile's intended use and support substantial equivalence of the Horos Mobile to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Function | Accuracy |
---|---|
Distance (1-10mm) | 100% |
Distance (>10mm) | 100% |
Area (1-10mm) | 100% |
Area (>10mm) | 100% |
Angle (1-190mm) | 100% |
Point (1-190mm) | 100% |
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).
FDA 510(k) Clearance Letter - Horos Mobile
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.07.05
iCat Solutions Ltd
℅ Bhoomika Joyappa
Senior Regulatory Consultant
Medical Device Academy, Inc.
345 Lincoln Hill Rd
Shrewsbury, Vermont 05738
Re: K242552
Trade/Device Name: Horos Mobile
Regulation Number: 21 CFR 892.2050
Regulation Name: Medical image management and processing system
Regulatory Class: Class II
Product Code: LLZ
Dated: March 11, 2025
Received: March 12, 2025
Dear Bhoomika Joyappa:
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"
April 8, 2025
Page 2
U.S. FOOD & DRUG ADMINISTRATION
iCat Solutions Ltd
℅ Bhoomika Joyappa
Senior Regulatory Consultant
Medical Device Academy, Inc.
345 Lincoln Hill Rd
Shrewsbury, Vermont 05738
April 8, 2025
Re: K242552
Trade/Device Name: Horos Mobile
Regulation Number: 21 CFR 892.2050
Regulation Name: Medical image management and processing system
Regulatory Class: Class II
Product Code: LLZ
Dated: March 11, 2025
Received: March 12, 2025
Dear Bhoomika Joyappa:
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"
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Page 3
K242552 - Bhoomika Joyappa Page 2
(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).
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 (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-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 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.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory-
Page 4
K242552 - Bhoomika Joyappa Page 3
assistance/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,
Jessica Lamb, Ph.D.
Assistant Director
Imaging Software Team
DHT8B: Division of Radiological Imaging
Devices and Electronic Products
OHT8: Office of Radiological Health
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Enclosure
Page 5
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
Indications for Use
Submission Number (if known): K242552
Device Name: Horos Mobile
Indications for Use (Describe)
Horos Mobile is a software device intended for viewing images acquired from computed tomography (CT), computed radiography (CR), magnetic resonance (MR), ultrasound (US) and other DICOM compliant medical imaging systems when installed on suitable commercial standard hardware. Images and data can be stored, communicated, processed, and displayed within the system.
It is intended for use as a diagnostic and review tool by trained healthcare professionals.
This device is not intended to replace full workstations and should be used only when there is no access to a workstation.
This device is not to be used for mammography.
It is the User's responsibility to operate the device in accordance with the software and hardware requirements listed in the instructions for use, in particular ensuring that display quality, ambient light conditions, and image compression ratios are consistent with the clinical application.
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)
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."
Page 6
510(k) Summary
1. SUBMITTER
Field | Value |
---|---|
Company Name | iCat Solutions Ltd |
Address | 51-59 Rose Lane, NR1 1BY, Norwich, United Kingdom |
tel | +44(0)7517456306 |
gm@icat.solutions | |
Contact Person | Georgios Michalopoulos |
2. DATE PREPARED
18-JUL-2024
3. DEVICE
Field | Value |
---|---|
Device Trade Name | Horos Mobile |
Classification Name | Medical Image Management and Processing System |
Regulation | 21 CFR 892.2050 |
Regulatory Class | Class II |
Device Panel | Radiology |
Product Classification Code | LLZ |
4. PREDICATE DEVICES
Predicate Device
Field | Value |
---|---|
Predicate Device Manufacturer | iCat Solutions Ltd |
Predicate Device Name | Horos MD™ (K232589) |
Predicate Device 510(k) | K232589 |
iCat Solutions Ltd
Page: 1 / 14
Page 7
510(k) Summary
1. SUBMITTER
Field | Value |
---|---|
Company Name | iCat Solutions Ltd |
Address | 51-59 Rose Lane, NR1 1BY, Norwich, United Kingdom |
tel | +44(0)7517456306 |
gm@icat.solutions | |
Contact Person | Georgios Michalopoulos |
2. DATE PREPARED
18-JUL-2024
3. DEVICE
Field | Value |
---|---|
Device Trade Name | Horos Mobile |
Classification Name | Medical Image Management and Processing System |
Regulation | 21 CFR 892.2050 |
Regulatory Class | Class II |
Device Panel | Radiology |
Product Classification Code | LLZ |
4. PREDICATE DEVICES
Predicate Device
Field | Value |
---|---|
Predicate Device Manufacturer | iCat Solutions Ltd |
Predicate Device Name | Horos MD™ (K232589) |
Predicate Device 510(k) | K232589 |
iCat Solutions Ltd
Page: 1 / 14
Page 8
510(k) Summary
Reference Device
Field | Value |
---|---|
Reference Device Manufacturer | MIM SOFTWARE INC. |
Reference Device Trade Name | Mobile MIM (K112930) |
Reference Device 510(k) | K112930 |
5. DEVICE DESCRIPTION
The Horos Mobile is an interactive medical image display software device for diagnostic image viewing of radiological images for the following modalities: X-ray, CT, MRI, Ultrasound, and XA for iOS and iPadOS platforms. The technological characteristics and the indications of use are identical to those of the Horos MD™ (K232589). The subject device provides both 2D and 3D image visualization tools for CT and MRI scans from various makes and models of image acquisition hardware. It does not produce any original medical images and does not contain controls for the direct operation of a diagnostic imaging system.
Horos Mobile conforms to the DICOM standard to allow the sharing of medical images with other digital imaging systems such as PACS (Picture Archiving and Communication System).
The Horos Mobile software device runs on the iOS and iPadOS platforms, leveraging of their optimized 3D graphic capabilities, which are provided by the METAL framework developed and maintained by Apple Inc.
The user interface of the software follows Apple's Human Interface Guidelines (HIG) to create a user interface that is intuitive and easy to use for users who are familiar with other Apple products. Typical users of this device are radiologists and clinicians who are familiar with 2D scan images.
Horos Mobile operates on "off-the-shelf" portable hardware devices and is therefore subject to factors not typical for reading room workstations (e.g. screen size, environmental variability, network dependencies, etc.). It is therefore required that the user follows the operating instructions properly and utilizes the risk mitigation features in order to make decisions safely and effectively.
6. INDICATIONS FOR USE
Horos Mobile is a software device intended for viewing images acquired from computed tomography (CT), computed radiography (CR), magnetic resonance (MR), ultrasound (US) and other DICOM compliant medical imaging systems when installed on suitable commercial standard hardware. Images and data can be stored, communicated, processed, and displayed within the system.
It is intended for use as a diagnostic and review tool by trained healthcare professionals.
This device is not intended to replace full workstations and should be used only when there is no access to a workstation.
This device is not to be used for mammography.
It is the User's responsibility to operate the device in accordance with the software and hardware requirements listed in the instructions for use, in particular ensuring that display quality, ambient light conditions, and image compression ratios are consistent with the clinical application.
iCat Solutions Ltd
Page: 2 / 14
Page 9
510(k) Summary
7. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
The following characteristics were compared between the subject device and the predicate device in order to demonstrate substantial equivalence:
Table 1: Comparison of Horos Mobile with Horos MD™ (K232589) and Mobile MIM (K112930)
Characteristics | Subject device Horos Mobile | Primary Predicate Horos MD™ | Reference Device Mobile MIM | Justification for differences with predicate device |
---|---|---|---|---|
Manufacturer | iCat Solutions Ltd | iCat Solutions Ltd | MIM SOFTWARE INC. | - |
510(k) Number | TBD | K232589 | K112930 | - |
Product classification | Class II | Class II | Class II | Same |
Regulation Number | 21 CFR 892.2050 | 21 CFR 892.2050 | 21 CFR 892.2050 | Same |
Product code | LLZ | LLZ | LLZ | Same |
Type of use | Prescription (Rx Only) | Prescription (Rx Only) | Prescription (Rx Only) | Same |
Class | II | II | II | Same |
Regulations number | 21 CFR 892.2050 | 21 CFR 892.2050 | 21 CFR 892.2050 | Same |
Regulation Name^ | Medical Image Management and Processing System | Medical Image Management and Processing System | Picture archiving and communications system | Same (For Reference Device: 21 CFR 892.2050 name has been amended in April 2021) |
Classification Name | System, image processing, radiological | System, image processing, radiological | System, image processing, radiological | Same |
Product code | LLZ | LLZ | LLZ | Same |
iCat Solutions Ltd
Page: 3 / 14
Page 10
510(k) Summary
Characteristics | Subject device Horos Mobile | Primary Predicate Horos MD™ | Reference Device Mobile MIM | Justification for differences with predicate device |
---|---|---|---|---|
Indications for Use | Horos Mobile is a software device intended for viewing images acquired from computed tomography (CT), computed radiography (CR), magnetic resonance (MR), ultrasound (US) and other DICOM compliant medical imaging systems when installed on suitable commercial standard hardware. Images and data can be stored, communicated, processed, and displayed within the system. It is intended for use as a diagnostic and review tool by trained healthcare professionals. This device is not intended to replace full workstations and should be used only when there is no access to a workstation. This device is not to be used for mammography. It is the User's responsibility to operate the device in accordance with the software and hardware requirements listed in the instructions for use, in particular ensuring that display quality, ambient light | Horos MD™ is a software device intended for viewing images acquired from computed tomography (CT), computed radiography (CR), magnetic resonance (MR), ultrasound (US) and other DICOM compliant medical imaging systems when installed on suitable commercial standard hardware. Images and data can be stored, communicated, processed, and displayed within the system. It is intended for use as a diagnostic and review tool by trained healthcare professionals. This device is not to be used for mammography. It is the User's responsibility to operate the device in accordance with the software and hardware requirements listed in the instructions for use, in particular ensuring that monitor (display) quality, ambient light conditions, and image compression ratios are consistent with the clinical application. | The Mobile MIM software program is used for the viewing, registration, fusion, and/or display for diagnosis of medical images from the following modalities: SPECT, PET, CT, MRI, X-ray and Ultrasound. Mobile MIM can be used to review images, contours, DVH, and isodose curves from radiation treatment plans. Mobile MIM can be used to approve these plans. Mobile MIM provides wireless and portable access to medical images. This device is not intended to replace full workstations and should be used only when there is no access to a workstation. This device is not to be used for mammography. | The primary indication of the subject device and the predicate device is to view medical images from different modalities for diagnosis. This subject device is not intended to replace a full workstation and should be used only where there is no access to a workstation. This operational limitation is consistent with the indications for use of the referenced device. |
iCat Solutions Ltd
Page: 4 / 14
Page 11
510(k) Summary
Characteristics | Subject device Horos Mobile | Primary Predicate Horos MD™ | Reference Device Mobile MIM | Justification for differences with predicate device |
---|---|---|---|---|
Indications for Use (continued) | conditions, and image compression ratios are consistent with the clinical application. | |||
Users | Trained healthcare professionals such as radiologists, clinicians and other qualified physicians | Trained healthcare professionals such as radiologists, clinicians and other qualified physicians | Trained healthcare professionals | Same |
Mammography diagnostic use | No | No | No | Same |
iCat Solutions Ltd
Page: 5 / 14
Page 12
510(k) Summary
Characteristics | Subject device Horos Mobile | Primary Predicate Horos MD™ | Reference Device Mobile MIM | Justification for differences with predicate device |
---|---|---|---|---|
Imaging modalities | • CT | |||
• MR | ||||
• CR | ||||
• DR | ||||
• US | • CT | |||
• MR | ||||
• CR | ||||
• DR | ||||
• US | • SPECT | |||
• PET | ||||
• CT | ||||
• MR | ||||
• X-ray | ||||
• Ultrasound | Same as the primary predicate device | |||
Communications | DICOM | DICOM | DICOM | Same |
Installation | Apple Handheld Devices | Local computers (Apple) | Apple Handheld Devices (Apple) | Difference: The subject device is compatible with iOS/iPadOS hardware, while the predicate device is compatible with MacOS hardware. The subject device has been adequately tested, and the difference does not raise concerns regarding safety or performance. Same as the reference device, the subject device can display images from various modalities on iOS and iPadOS hardware. |
iCat Solutions Ltd
Page: 6 / 14
Page 13
510(k) Summary
Characteristics | Subject device Horos Mobile | Primary Predicate Horos MD™ | Reference Device Mobile MIM | Justification for differences with predicate device |
---|---|---|---|---|
Operating system for diagnostic viewing | iOS (iPhone), iPadOS (iPad) | MacOS (Mac) | iOS (iPhone, iPod Touch), iPadOS (iPad) | Difference: The subject device is compatible with iOS/iPadOS, while the predicate device is compatible with MacOS. The subject device has been adequately tested, and the difference does not raise concerns regarding safety or performance. Same as the reference device, the subject device can display images from various modalities on iOS and iPadOS. Hence, both the subject and the reference devices are considered substantially equivalent concerning the aspects of hardware for diagnostic image viewing. |
iCat Solutions Ltd
Page: 7 / 14
Page 14
510(k) Summary
Characteristics | Subject device Horos Mobile | Primary Predicate Horos MD™ | Reference Device Mobile MIM | Justification for differences with predicate device |
---|---|---|---|---|
User authentication (unique login) | Yes | Yes | Yes | Same |
Receive, Store, Retrieve, Display, and Process Digital Medical Images | yes | yes | yes | Same |
iCat Solutions Ltd
Page: 8 / 14
Page 15
510(k) Summary
Characteristics | Subject device Horos Mobile | Primary Predicate Horos MD™ | Reference Device Mobile MIM | Justification for differences with predicate device |
---|---|---|---|---|
Basic visualization tools | • Grayscale display | |||
• Rotate | ||||
• Pan | ||||
• Zoom | ||||
• Fit to screen | ||||
• Scroll | ||||
• Flip horizontal / vertical | ||||
• Axial / coronal / sagittal views | ||||
• Cross-hair | ||||
• Adjustable windowing (WW/WL) | ||||
• HU (Hounsfield Unit) | ||||
• Slice indicator | ||||
• Reset | • Grayscale display | |||
• Rotate | ||||
• Pan | ||||
• Zoom | ||||
• Fit to screen | ||||
• Scroll | ||||
• Flip horizontal / vertical | ||||
• Axial / coronal / sagittal views | ||||
• Cross-hair | ||||
• Adjustable windowing (WW/WL) | ||||
• HU (Hounsfield Unit) | ||||
• Slice indicator | ||||
• Reset | • Grayscale display | |||
• Pan | ||||
• Zoom | ||||
• Scroll | ||||
• Axial / coronal / sagittal views | ||||
• Cross-hair | ||||
• Adjustable windowing (WW/WL) | ||||
• HU (Hounsfield Unit) | ||||
• Slice indicator | Same as the primary predicate device. The subject device includes additional image manipulation features compared to the reference device. These features use the exact same technology as the primary predicate device. The additional visualization tools compared to the reference device, do not alter the device's intended use or indications for use, nor they introduce any new safety risks. Therefore, there is no risk to the device's safety or performance. |
iCat Solutions Ltd
Page: 9 / 14
Page 16
510(k) Summary
Characteristics | Subject device Horos Mobile | Primary Predicate Horos MD™ | Reference Device Mobile MIM | Justification for differences with predicate device |
---|---|---|---|---|
Advanced tools | • Volume Rendering (3D) | |||
• MPR | • Volume Rendering (3D) | |||
• MPR | • MPR | Same as the primary predicate device | ||
Measurements | • Line | |||
• Angle | ||||
• Area (circular, irregular shape, polygonal) | ||||
• Point | ||||
• Cobb Angle | ||||
• CTR | • Line | |||
• Angle | ||||
• Area (circular, irregular shape, polygonal) | ||||
• Point | ||||
• Cobb Angle | ||||
• CTR | • Line (Distance) | |||
• Area - Circular (SUV) | Same as the primary predicate device. The additional measurement tools compared to the reference device, do not alter the device's intended use or indications for use, nor they introduce any new safety risks. Therefore, there is no risk to the device's safety or performance. | |||
Annotations | yes | yes | yes | Same |
iCat Solutions Ltd
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Characteristics | Subject device Horos Mobile | Primary Predicate Horos MD™ | Reference Device Mobile MIM | Justification for differences with predicate device |
---|---|---|---|---|
Anonymization function | yes | yes | no | Same as the primary predicate device. The reference device does not include Anonymization feature. This addition does not alter the device's intended use or indications for use, nor does it introduce any new safety risks. Therefore, there is no risk to the device's safety or performance. |
Studies comparison | yes | yes | no | Same as the primary predicate device |
Share function | yes | yes | yes | Same |
Export functions | Yes (JPEG, .dcm, .zip) | Yes (JPEG, .dcm, .zip) | Yes (.mma) | Same as the primary predicate device |
Report generation | No | No | No | Same |
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Characteristics | Subject device Horos Mobile | Primary Predicate Horos MD™ | Reference Device Mobile MIM | Justification for differences with predicate device |
---|---|---|---|---|
Device type/ form | Software device that operates on off-the-shelf hardware | Software device that operates on off-the-shelf hardware | Software device that operates on off-the-shelf hardware | Same |
DICOM standard for data exchange | NEMA PS3.1 2023b (2023) Digital Imaging and Communications In Medicine (Dicom) Set | NEMA PS3.1 2023b (2023) Digital Imaging and Communications In Medicine (Dicom) Set | Not Available | Same |
JPEG standard for image compression | IEC/ ISO 10918-1, Edition 1 (1994-02-15), Information Technology – Digital Compression and Coding of Continuous-Tone Still Images: Requirements And Guidelines [Including: Technical Corrigendum 1 (2005) | IEC/ ISO 10918-1, Edition 1 (1994-02-15), Information Technology – Digital Compression and Coding of Continuous-Tone Still Images: Requirements And Guidelines [Including: Technical Corrigendum 1 (2005) | Not Available | Same |
^The Regulation 21 CFR 892.2050 name has been amended in April 2021
8. EVALUATION OF SIMILARITIES AND DIFFERENCES
The Horos Mobile demonstrates substantial equivalence to the primary predicate, Horos MD™ (K232589), and reference device, Mobile MIM (K112930) by MIM SOFTWARE INC., in terms of classification, regulation, and intended medical image management use.
There is no difference between the subject device (Horos Mobile) and the predicate and reference devices in terms of its intended use, indications for use, and fundamental scientific technology. The subject device has equivalent intended use and indications for use as the predicate device, with a minor difference in terms of OS compatibility. This minor difference in OS compatibility does not raise any new concerns regarding safety or effectiveness.
The subject device is equivalent in terms of technological characteristics, including overall design, mechanism of action, mode of operation, and performance characteristics, as well as its intended use, to the primary predicate device. The non-clinical performance test data, as well as the software verification and validation, demonstrate that the subject device performs comparably to, and is as safe and effective as, the predicate device.
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To address additional indications, MIM has been selected as the reference device, which supports portable device characteristics and accessibility when a full workstation is not available. Thus, Horos MD™ (K232589) is substantially equivalent to both the predicate and reference devices in terms of safety and effectiveness. In accordance with 21 CFR Part 807 and based on the information provided in this premarket notification, Horos MD™ (K232589) is substantially equivalent to the predicate device.
9. PERFORMANCE DATA
The following performance data were provided in support of the substantial equivalence determination.
Non-Clinical Data
• Software Verification and Validation Testing
All of the different components of Horos Mobile software have been tested to ensure that the system as a whole provides all the capabilities necessary to operate according to its intended use. Software verification and validation testing were conducted, and documentation was provided as detailed in FDA's Guidance for Industry and FDA Staff: "Guidance for the content of Premarket Submissions for Software Contained in Medical Devices."
iCat Solutions Ltd has implemented security features for the device and data protection. Cybersecurity requirements, risk analysis, and mitigation was addressed in accordance with FDA guidance Content of Premarket Submission for Management of Cybersecurity in Medical Devices (Oct 2014).
• Bench Performance Testing
No clinical testing was required to demonstrate safety or effectiveness for the subject device as the device's non-clinical (bench) testing was sufficient to support the intended use of the device.
The measurement accuracy for the distance (length), angle, point, and area features was validated using automated tests with Digital Reference Objects (DROs) compared against known values. The DROs (n=75 test cases) created were representative of the clinical range typically encountered in radiology practice (1-190 mm). Inter-system error (robustness) and intra-system error (consistency) were assessed using automated processes.
Function | Accuracy |
---|---|
Distance (1-10mm) | 100% |
Distance (>10mm) | 100% |
Area (1-10mm) | 100% |
Area (>10mm) | 100% |
Angle (1-190mm) | 100% |
Point (1-190mm) | 100% |
Display Performance Bench Testing Summary
Bench testing was conducted to evaluate the display performance of the Horos Mobile DICOM Viewer on the iPhone 14 Pro Max and the iPad Pro 12.9-inch. This testing, carried out in accordance with IEC 62563-1, assessed the following key performance characteristics:
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• Luminance Response Evaluation (DICOM GSDF)
• Luminance Uniformity Evaluation
• Qualitative Image Quality Evaluation, including:
• Greyscale evaluation
• Greyscale (contrast) resolution evaluation
• Contrast evaluation
• Pixel resolution evaluation
• Angular viewing evaluation
This bench testing demonstrated that the designated hardware platforms are appropriate for Horos Mobile's intended use and support substantial equivalence of the Horos Mobile to the predicate devices.
10. CONCLUSIONS
There is no difference between the subject device (Horos Mobile) and the predicate and reference devices in terms of its intended use, indications for use and fundamental scientific technology. Neither device differs in usage, safety, or effectiveness, thus no new questions regarding safety or effectiveness are raised. The non-clinical performance test data and software verification and validation demonstrate that the subject device performs comparably to and is as safe and effective as the predicate device. In accordance with the 21 CFR Part 807 and based on the information provided in this premarket notification, Horos Mobile is substantially equivalent to the predicate device.
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