(74 days)
Not Found
No
The summary describes standard image processing and data management functions typical of a medical image viewer, with no mention of AI, ML, or related concepts.
No
The description states the device is used for image processing and administration of medical X-ray data for diagnosis, not for treatment or therapy.
Yes
Explanation: The "Device Description" states, "ClearON Mobile provides easy touch based user interface to perform diagnosis of digital radiograph images displayed on ClearOn Mobile." This explicitly indicates its use for diagnosis.
Yes
The device is described as "Clear On Mobile software" and its functions are solely related to processing, displaying, and managing digital X-ray images and patient data. While it receives data from hardware (flat panel detector and X-ray generator), the device itself is the software performing the image processing and administration.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. The intended use and device description clearly state that this software processes and displays medical X-ray data, which are images of the inside of the body, not specimens.
- The device's function is image processing and administration of medical X-ray data. This falls under the category of medical imaging software, not in vitro diagnostics.
The information provided describes a device used for viewing, manipulating, and managing medical images obtained from an X-ray system. This is characteristic of a medical image viewer or PACS (Picture Archiving and Communication System) component, not an IVD.
N/A
Intended Use / Indications for Use
Clear On Mobile software carries out the image processing and administration of medical X-ray data which includes adjustment of window leveling, rotation, zoom, and measurements. Clear on Mobel is not approved for mammography and is meant to be used by qualified medical personnel only. Clear On Mobile is complying with DICOM standards to assure optimum communications between network systems.
Product codes (comma separated list FDA assigned to the subject device)
LLZ
Device Description
ClearON Mobile provides easy touch based user interface to perform diagnosis of digital radiograph images displayed on ClearOn Mobile. ClearON Mobile receives digital images from a flat panel detector and a X-ray generator. The software also manages patient data, stores and transfers diagnostic images in an internal database. It supports DICOM image file format which allows interoperability with other Radiography equipment in network environment.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
qualified medical personnel
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)
Nonclinical Testing: The complete system configuration has been assessed and tested by the manufacturer and passed all testing acceptance criteria. The software validation test was designed to evaluate all input functions, output functions, and actions performed by ClearOn Mobile. Each operational mode and the processes are documented in the Software Validation Report. The validation testing verified and validated the risk analysis and individual performance results were within the predetermined acceptance criteria.
Safety and Performance Data: The SW validation and risk analysis based on FMEA were conducted. The risks identified have been mitigated and any residual risks were evaluated and accepted.
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).
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March 1, 2019
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Rayence Co., Ltd. % Mr. Dave Kim Medical Device Regulatory Affairs Mtech Group 8310 Buffalo Speedway HOUSTON TX 77025
Re: K183478
Trade/Device Name: ClearON Mobile Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: LLZ Dated: December 13, 2018 Received: December 17, 2018
Dear Mr. Kim:
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/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.
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
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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Michael D. O'Hara
For
Robert Ochs, Ph.D. 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) K183478
Device Name ClearON Mobile
Indications for Use (Describe)
Clear On Mobile software carries out the image processing and administration of medical X-ray data which includes adjustment of window leveling, rotation, zoom, and measurements. Clear on Mobel is not approved for mammography and is meant to be used by qualified medical personnel only. Clear On Mobile is complying with DICOM standards to assure optimum communications between network systems.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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1. 510(k) Summary-K183478
This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.
Date 510K summary prepared: December 13, 2018
Submitter's Name, address, telephone number, a contact person:
| Submitter's Name : | Rayence Co., Ltd. |
|---|---|
| Submitter's Address: | 14, Samsung 1-ro 1-gil, Hwaseong-si, Gyeonggi-do, Korea |
| Submitter's Telephone: | +82-31-8015-6459 |
| Contact person: | Mr. Kee Dock Kim / RA Team Manager / +82-31-8015-6459 |
| Official Correspondent: | Dave Kim (davekim@mtech-inc.net) |
| Address: | 8310 Buffalo Speedway, Houston, TX 77025 |
| Telephone: | +713-467-2607 |
| Fax: | +713-583-8988 |
Name of the device, including the trade or proprietary name if applicable, the common or usual name and the classification name, if known:
| Type of 510k Submission: | Special |
|---|---|
| Trade/proprietary name: | ClearOn Mobile |
| Common Name: | Medical Image Processing Software |
| Regulatoin number: | 21 CFR 892.2050 |
| Classification Name : | Picture archiving and communications system |
| Product Code: | LLZ |
| Predicate device | |
| Manufacturer: | Rayence Co., Ltd. |
| Device Name : | XmaruView V1 |
| 510(k) Number: | K160579 (Decision Date – Apr 08, 2016) |
| Common Name: | Medical Image Processing Software |
| Regulatoin number: | 21 CFR 892.2050 |
| Classification Name : | Picture archiving and communications system |
| Product Code: | LLZ |
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2. Device Description
ClearON Mobile provides easy touch based user interface to perform diagnosis of digital radiograph images displayed on ClearOn Mobile. ClearON Mobile receives digital images from a flat panel detector and a X-ray generator. The software also manages patient data, stores and transfers diagnostic images in an internal database.
It supports DICOM image file format which allows interoperability with other Radiography equipment in network environment.
Image /page/4/Figure/3 description: The image shows a diagram of a system with different components. The components include a user, administrator, PACS, DICOM files, DICOM service, DB, printer, detector, X-ray generator, ClearOn Mobile, image processing, and detector controller. The ClearOn Mobile component is connected to several other components, including the user, administrator, DB, DICOM files, DICOM service, image processing, detector controller, and printer.
3. Indication for use
ClearOn Mobile software carries out the image processing and administration of medical X-ray data which includes adjustment of window leveling, rotation, zoom, and measurements. ClearOn Mobel is not approved for mammography and is meant to be used by qualified medical personnel only. ClearOn Mobile is complying with DICOM standards to assure optimum communications between network systems.
4. The Main Functions of ClearON Mobile
The major functions of ClearON Mobile are as follows.
- Automatic transfer of patient information and image data through the DICOM Worklist. -
- -Auto Query that searches the Worklist server at each designated interval and handle new works rapidly and efficiently.
- Display an image within a short period of time after taking an image. -
- Enables a user to conduct a variety of functions, including DICOM image transmission, printing, and Worklist search.
- Provides image editing functions, including Contrast, Invert, Rotate, ROI, and Windowing. -
- lmage management functions: test creation, modify and delete information, move and delete image, and image storage management.
- -Supports DICOM 3.0, data transfer to the PACS server, print and Worklist jobs.
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5. Interoperation products
ClearON Mobile are compatible with the following detectors and generators:
-
Ravence's Detector
-
Generator -
-
EDITOR HFe 501(Spellman) 1
-
트 CMP200(CPI)
-
1 SYNERGY(SUMMIT)
6. Substantial Equivalence
ClearON Moblie SW and the predicate device, XmaruView V1 image viewer software are substantially equivalent, having the same / similar indications for use and functionalities such as image processing, windowing, zoom, rotation, contrast, brightness, inverting view, annotation, DICOM worklist, DICOM store and DICOM print. The differences are cosmetic, such as layout of UI and touch screen interface for the ClearON Mobile. Both subject device and predicate device are categorized as the product code LLZ; equivalence between the subject and predicate device is evident.
The pre and post image processing algorithm is identical for both ClearON Mobile and XmaruView V1.
The differences between the subject and predicate device are as follows:
- ClearON Mobile is compatible with a Window 10 based touch screen device. For example, zoom, drawing and measurement can be done with touch of a finger(s) in stead of a conventional keyboard/mouse input.
7.Summary of Performance Testing
-
- Nonclinical Testing:
The complete system configuration has been assessed and tested by the manufacturer and passed all testing acceptance criteria. The software validation test was designed to evaluate all input functions, output functions, and actions performed by ClearOn Mobile. Each operational mode and the processes are documented in the Software Validation Report.
- Nonclinical Testing:
The validation testing verified and validated the risk analysis and individual performance results were within the predetermined acceptance criteria.
-
- Safety and Performance Data:
The SW validation and risk analysis based on FMEA were conducted. The risks identified have been mitigated and any residual risks were evaluated and accepted.
- Safety and Performance Data:
-
IEC 62304 Medical device software Software life-cycle processes : 2006
-
ISO 14971 Medical Devices Application of risk management to medical device : 2007
8. Conclusions
None of the modifications alter the Indications for Use in a significant way, nor the fundamental scientific technology, and do not introduce any new technology. Therefore, it is our opinion that the ClearON Mobile described in this submission is substantially equivalent to the predicate device, XmaruView V1.