(38 days)
Not Found
No
The document describes standard image processing, PACS functionalities, and DICOM compatibility, with no mention of AI, ML, or related concepts.
No
This device is a software for image processing and management of medical X-ray data, used for diagnostic purposes, not for therapeutic intervention.
No
The device is described as software that processes, stores, and displays medical X-ray data. While it supports viewing diagnostic images, its intended use and functionalities do not include making diagnoses or providing diagnostic interpretations. It is a tool for managing and displaying existing diagnostic images, not for generating a diagnosis itself. The text explicitly states it carries out "image processing and administration of medical X-ray data" and "manages, searches and views the stored images."
No
The device description explicitly states that the software "controls a flat-panel detector and a X-ray generator to acquire digital images," indicating interaction with and control over hardware components beyond just a standard PC.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device function: The description clearly states that the device processes and manages medical X-ray data (images). It controls a flat-panel detector and X-ray generator to acquire digital images. This is related to medical imaging, not laboratory testing of biological samples.
- Intended Use: The intended use focuses on image processing, administration of X-ray data, and communication with other medical systems. It does not mention any analysis of biological samples.
Therefore, the device described is a medical imaging software and PACS system, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Xmaru View V1(Xmaru Chiroview or Xmaru Podview) software carries out the image processing and administration of medical X-ray data which includes adjustment of window leveling, rotation, zoom, and measurements. Xmaru View V 1(Xmaru Chiroview or Xmaru Podview) is not approved for mammography and is meant to be used by qualified medical personnel only. Xmaru Chiroview or Xmaru Podview) is complying with DICOM standards to assure optimum communications between network systems.
Xmaru PACS receives, stores, searches and views the diagnostic image data from imaging modalities in DICOM compliant. Xmaru PACS is capable of communicating with electronic medical records systems, hospital information systems, and radiology information system via DICOM standard.
Xmaru View V1(Xmaru Chiroview or Xmaru Podview) and Xmaru PACS can be packaged together or offered as a standalone imaging solution to be installed in a PC for trained medical professionals.
Product codes (comma separated list FDA assigned to the subject device)
LLZ
Device Description
XmaruView V1(Xmaru Chiroview or Xmaru Podview) is a software program designed to provide image acquisition, processing and operational management functions for digital radiography.
XmaruView V1(Xmaru Chiroview or Xmaru Podview) controls a flat-panel detector and a X-ray generator to acquire digital images. The software also manages patient information, capture and store diagnostic images in an internal database. It also supports DICOM which allows compatibility with other radiography equipment and network programs. XmaruView V1(Xmaru Chiroview or Xmaru Podview) provides a streamlined and optimized process of multiple workflows in any hospital environment for digital radiography.
Xmaru PACS is in charge of receiving the images from multiple modalities and storing data in the server. This software manages, searches and viewes the stored images in the server. Xmaru PACS is capable of communicating with electronic medical records systems, hospital information systems, and radiology information system via DICOM standard.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray data, DX, CR, CT, US, MR, PET
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
qualified medical personnel, trained medical professionals, any hospital environment
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 in-house testing criteria. The software validation test was designed to evaluate all input functions, output functions, and actions performed by XmaruView V1(Xmaru Chiroview or Xmaru Podview) and Xmaru PACS. Each operational mode and the process followed 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.
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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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right. The profiles are stacked on top of each other, with the top profile being the smallest and the bottom profile being the largest.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 8, 2016
Rayence Co., Ltd. % Mr. Dave Kim Medical Device Regulatory Affairs Mtech Group 8310 Buffalo Speedway HOUSTON TX 77025
Re: K160579
Trade/Device Name: Xmaru View V1(Xmaru Chiroview or Xmaru Podview) and Xmaru PACS, Medical Image Processing Software Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: February 26, 2016 Received: March 1, 2016
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. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Michael D.'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) K160579
Device Name
Xmaru View V1(Xmaru Chiroview or Xmaru Podview) and Xmaru PACS Medical Image Processing Software
Indications for Use (Describe)
Xmaru View V1(Xmaru Chiroview or Xmaru Podview) software carries out the image processing and administration of medical X-ray data which includes adjustment of window leveling, rotation, zoom, and measurements. Xmaru View V 1(Xmaru Chiroview or Xmaru Podview) is not approved for mammography and is meant to be used by qualified medical personnel only. Xmaru Chiroview or Xmaru Podview) is complying with DICOM standards to assure optimum communications between network systems.
Xmaru PACS receives, stores, searches and views the diagnostic image data from imaging modalities in DICOM compliant. Xmaru PACS is capable of communicating with electronic medical records systems, hospital information systems, and radiology information system via DICOM standard.
Xmaru View V1(Xmaru Chiroview or Xmaru Podview) and Xmaru PACS can be packaged together or offered as a standalone imaging solution to be installed in a PC for trained medical professionals.
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
This summary of 510(k) information is being submitted in accordance with requirements of 21 CFR Part 807.92.
Date 510K summary prepared: FEB. 26, 2016
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:
| Trade/proprietary name: | XmaruView V1, Xmaru Chiroview, Xmaru Podview and
Xmaru PACS |
|-------------------------|----------------------------------------------------------------|
| Common Name: | Medical Image Processing Software |
| Regulatoin number: | 21 CFR 892.2050 |
| Classification Name : | System, Image Processing, Radiological |
| Product Code: | LLZ |
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2. Device Description
XmaruView V1(Xmaru Chiroview or Xmaru Podview) is a software program designed to provide image acquisition, processing and operational management functions for digital radiography.
XmaruView V1(Xmaru Chiroview or Xmaru Podview) controls a flat-panel detector and a X-ray generator to acquire digital images. The software also manages patient information, capture and store diagnostic images in an internal database. It also supports DICOM which allows compatibility with other radiography equipment and network programs. XmaruView V1(Xmaru Chiroview or Xmaru Podview) provides a streamlined and optimized process of multiple workflows in any hospital environment for digital radiography.
Xmaru PACS is in charge of receiving the images from multiple modalities and storing data in the server. This software manages, searches and viewes the stored images in the server. Xmaru PACS is capable of communicating with electronic medical records systems, hospital information systems, and radiology information system via DICOM standard.
Image /page/4/Figure/4 description: This image shows a diagram of the Xmaru PACS system. The diagram includes the XmaruView V1, Xmaru Chiroview, and Xmaru PodView software. The diagram also shows the different types of modalities that can be used with the system, such as DX, CR, CT, US, and MR. The image also shows the different clients that can be used to access the system, such as Client 1, Client 2, Client 3, and Client n.
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| Function
| Model name | Basic | Chiropractic mode | Podiatry mode |
|---|---|---|---|
| XmaruView V1 | O | X | X |
| Xmaru Chiroview | O | O | X |
| Xmaru Podview | O | X | O |
Note) XmaruView V1 Naming Rules
3. Indication for use
XmaruView V1(Xmaru Chiroview or Xmaru Podview) software carries out the image processing and administration of medical X-ray data which includes adjustment of window leveling, rotation, zoom, and measurements. XmaruView V1(Xmaru Chiroview or Xmaru Podview) is not approved for mammography and is meant to be used by qualified medical personnel only. XmaruView V1(Xmaru Chiroview or Xmaru Podview) is complying with DICOM standards to assure optimum communications between network systems.
Xmaru PACS receives, stores, searches and views the diagnostic image data from imaging modalities in DICOM compliant. Xmaru PACS is capable of communicating with electronic medical records systems, hospital information systems, and radiology information system via DICOM standard.
XmaruView V1(Xmaru Chiroview or Xmaru Podview) and Xmaru PACS can be packaged together or offered as a stand-alone imaging solution to be installed in a PC for trained medical professionals.
4. The Main Functions of XmaruView V1(Xmaru Chiroview or Xmaru Podview) and Xmaru PACS
The major functions of XmaruView V1(Xmaru Chiroview or Xmaru Podview) are as follows.
- Automatic acquisition of patient information and photo-taking when taking a shot through the DICOM Worklist.
- Auto Query that searches the Worklist server at every designated interval, facilitating to handle newly added works rapidly and efficiently.
- Display an acquired image within a very short period of time after taking an image. -
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- Reduce input time for patient information by automatically applying the preset Image Processing Parameter, ROI, Marker, LUT etc. according to different body parts.
- Enables a user to take images simultaneously while conducting a variety of functions, including DICOM image transmission, printing, and Worklist search.
- Provides a variety of image editing functions, including Contrast, Invert, Flip, Rotate, ROI, and Windowing.
- Enable a user to edit images upon acquisition -
- Image management functions: test creation, modify and delete of information, move and delete of image, and image storage management.
- Supports DICOM 3.0 and image transmission to the PACS server, print and worklists. -
- Chiropractic mode, Podiatry mode -
The major functions of Xmaru PACS are as follows.
- Adjust images in real time through searching functions of acquired images -
- Perform DICOM image sending and printing -
- Provide various image processing functions such as contrast, invert, flip, rotate, ROI, windowing
- Perform image searching, transferring, deleting, managing storage capacity easily -
- Perform image sending to PACS, printing and Worklist because DICOM 3.0 is supported -
- Provide Server and Client mode -
5. Predicate device
| Manufacturer | : VATECH Co.,Ltd. | ||
|---|---|---|---|
| Device | : XmaruView V1 | ||
| 510(k) Number | : K102078 (Decision Date - AUG 10, 2011) | ||
| Characteristi | |||
| C | Proposed | ||
| Rayence Co.,Ltd. | |||
| Xmaru View V1, Xmaru | |||
| Chiroview, Xmaru Podview and | |||
| Xmaru PACS | Predicate | ||
| VATECH Co.,Ltd. | |||
| XmaruView V1 | |||
| * Rayence Co., Ltd - May, 2011 | |||
| (Separated from Vatech Co., Ltd. as an Independent Affiliate Company) | |||
| 510(k) number | K102078 | ||
| Decision Date - AUG. 10, 2011 | |||
| Characteristi | |||
| C | Proposed | ||
| Rayence Co.,Ltd. | |||
| XmaruView V1, Xmaru | |||
| Chiroview, Xmaru Podview and | |||
| Xmaru PACS | Predicate | ||
| VATECH Co.,Ltd. | |||
| XmaruView V1 | |||
| Processor | Intel® Core™ i3 or higher | Intel Core Duo/Core 2 Duo Core | |
| Processor | |||
| RAM | 4GB or higher | min. 1GByte RAM | |
| Hard Disk | min. 80GByte | min. 80GByte | |
| Network | 100MBit or 1GBit | 100MBit or 1GBit | |
| Operation | |||
| Software | Microsoft Windows 7(32 bit / 64 bit) | ||
| Professional | |||
| Microsoft Windows 8 Professional or | |||
| Enterprise | Windows XP | ||
| Resolution | min. 1280 x 768 | 1280 x 1024 | |
| X-ray | |||
| Generator | |||
| Control | XmaruView V1(Xmaru Chiroview | ||
| or Xmaru Podview) – Yes | |||
| Xmaru PACS - No | Yes | ||
| Image | |||
| Processing | Yes (same with the predicate device) | Yes | |
| Windowing | Yes | Yes | |
| Image | |||
| Formatting | Yes (1x1,1x2,2x1,2x2,3x3) | Yes (1x1,1x2,2x1,2x2,3x3) | |
| Electronic zoom | Yes | Yes | |
| Image rotation | Yes | Yes | |
| DICOM | |||
| Worklist | Yes | Yes | |
| DICOM Store | Yes | Yes | |
| Characteristi | |||
| C | Proposed | ||
| Rayence Co.,Ltd. | |||
| Xmaru View V1, Xmaru | |||
| Chiroview, Xmaru Podview and | |||
| Xmaru PACS | Predicate | ||
| VATECH Co.,Ltd. | |||
| Xmaru View V1 | |||
| DICOM Print | Yes | Yes | |
| SW Ver. | XmaruView V1(Xmaru Chiroview | ||
| or Xmaru Podview) - 2.0 | |||
| Xmaru PACS - 1.0 | Xmaru View V1 - | ||
| 1.0 | |||
| Added | |||
| Functions | XmaruView V1(Xmaru Chiroview | ||
| or Xmaru Podview) - 2.0 |
- Add features
- Auto Stitching
- Improve features
- Change Image Processing Tab
- GPR parameter selectable
- Added mode
- Chiropractic mode
- Podiatry mode
- Xmaru View V1 divided the
model name.
- XmaruView V1
- Xmaru Chiroview
- Xmaru Podview
Xmaru PACS - 1.0
- Store SCP :
Ability to receive images
transmitted from modalities - Available Modality Image
Display
DX, CR, CT, MR, MG, US and
PET image modalities | | |
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6. Substantial Equivalence
The subject device and predicate device are substantially equivalent, having the same/similar indications for use and functionalities like operation software, resolution, X-ray generator control, image processing, windowing, zoom, rotation, DICOM worklist, DICOM store and DICOM print. Both subject device and predicate devices are categorized in product code
9
LLZ; equivalence between these models is evident.
-
- The pre / post image processing algorithm is the same for XmaruView V1( ver 1.0) and XmaruView V1( ver 2.0).
- The differences betweeen XmaruView V1 (ver 1.0) and XmaruView V1 (ver 2.0) are as follows:
- 1). Add features
- Auto Stitching
- 2). Improve features
- Change Image Processing Tab
- Selectable GPR parameter
- 3). Added mode
- Chiropractic mode
- Podiatry mode
- 4). XmaruView V1 divided into different model names.
- XmaruView V1
- Xmaru Chiroview
- Xmaru Podview
The SW Validation, hazard analysis and FMEA, modality validation and functional test were conducted for the software features which are added or changed from XmaruView V1 (ver 1.0), the previous version. The risks identified have been mitigated and any residual risks were evaluated and accepted for XmaruView V1 (ver 2.0).
- Chiropractic mode and Podiatry mode in XmaruView V1 ( ver 2.0) are additional features for XmaruView V1 ( ver 2.0). However, they are similar to the measurement function of length and angle already incorporated in XmaruView V1 (Ver 1.0) For the user convenience, a specific region of interest for chiropractic and podiatry was designated as a dedicated mode in XmaruView V1 ( ver 2.0).
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7.Summary of Performance Testing
Nonclinical Testing:
The complete system configuration has been assessed and tested by the manufacturer and passed all in-house testing criteria. The software validation test was designed to evaluate all input functions, output functions, and actions performed by XmaruView V1(Xmaru Chiroview or Xmaru Podview) and Xmaru PACS. Each operational mode and the process followed 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:
- IEC 62304 Medical device software Software life-cycle processes : 2006
- ISO 14971 Medical Devices Application of risk management to medical device : 2007
- NEMAPS 3.1-3.20 Digital Imaging and Communications in Medicine (DICOM) Set (Radiology)
8. Conclusions
None of the modifications alter the Indications for Use in a significant way, nor the fundamental scientific technology, and do not introduce a fundamentally new scientific technology. Therefore, it is our opinion that the XmaruView V1(Xmaru Chiroview or Xmaru Podview) described in this submission is substantially equivalent to the predicate device.