(54 days)
No
The summary describes a mobile medical image viewer with standard image manipulation and display features. There is no mention of AI, ML, or advanced image analysis beyond basic processing (pan, zoom, window level). The performance studies focus on software verification and display quality, not algorithmic performance.
No.
The device is described as software for displaying medical images for diagnosis or referring purposes, not for providing therapy.
Yes
The "Intended Use / Indications for Use" section states that the software is "intended to display images... for the trained physician's diagnosis or referring purpose." While it also states it's "not intended to be used as, or to replace, a full diagnostic workstation," its primary purpose includes enabling diagnosis by a physician.
Yes
The device description explicitly states "UDE is a software device" and details its installation on iOS platforms (iPad Pro, iPad, iPhone). While it relies on existing hardware (Apple devices and a UDE server), the device itself, as described for regulatory purposes, is the software application.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The intended use and device description clearly state that this software displays and processes medical images (CT, MR, CR, etc.) obtained from imaging modalities, not from analyzing biological specimens.
- The device's function is to display and manipulate medical images for diagnostic or referring purposes. This falls under the category of medical image display and processing software, which is distinct from IVD devices.
Therefore, while this is a medical device used in the diagnostic process, it does not meet the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
UDE software is intended to display images from CT, MR, CR, US, XA and SC for the trained physician 's diagnosis or referring purpose. UDE provides wireless and portable access to medical images. It is not intended to be used as, or to replace, a full diagnostic workstation or system and should be used only when there is no access to a workstation. This device is not to be used for mammography diagnosis.
Product codes
LLZ
Device Description
UDE is a software device that can be installed on Apple iPad Pro. Through wireless network, user can login, query and display the images which are stored in heir existing UDE server. The device can be installed in iOS 9, 11, 12 and 13 version platform such as iPad /iPhone, but can't be installed in platforms other than iOS 9, 11, 12 and 13 version . The image display quality on iPad /iPhone will be almost the same as on iPad Pro when it is used for diagnosis purpose of CT, MR, US, XA and SC. However, if it is used for CR diagnosis purpose, we will strongly suggest that users should adopt iPad Pro. because the screen size of iPad Pro is larger than those of Apple® iPad/iPhone.
Main features of UDE are listed below
- Receive, Store, Retrieve, Display, and Process Digital Images(CT, MR, US, CR, Full- Field . Mammography, XA,SC etc.)
- · The displayed CT, MR, CR,, US,XA and SC images can be diagnosed by the trained physicians.
- . The displayed CT, MR, CR, Full- Field Mammography, US, XA and SC images can be referred by the trained physicians. Mammography images are not for diagnostic use
- · Communication log file
- · Auto delete old images (FIFO)
- · Overlay labels
- · User Authentication
- Display of Clinical Patient Data .
- Distance Calculation
- · layout adjustment (1×1, 2×1, 1×2, 2×2)
- · Pan
- Zoom
- Window Level
- · Cine Loop
- Mammography hanging protocol
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT, MR, CR, US, XA, SC, Full- Field Mammography
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained physician 's diagnosis or referring purpose / 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)
The software verification testing and validation testing based on IEC 62304 workflows have been performed by designed engineer or professional personnel. These testing include unit, integration and system tests. The test results of software verification and validation had all met and passed the acceptance criteria referred to medical image software quality request.
The non-clinical performance of display had been conducted according to the description and requirements described in the AAPM Assessment of Display Performance for Medical Imaging Devices (2005) document by a third party to ensure high quality laboratory results. All tests had passed successfully.
Given the differences from the predicate device iDO Viewer (K140399), no clinical testing of the UDE software is necessary for this submission. The subject software is based on the cleared predicate. Moreover, bench testing results are showing adequate performance of the iPad Pro display used in combination with the UDE software.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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).
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October 5, 2020
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.
EBM Technologies, Inc. % Mr. John Su Regulatory Affairs Manager 5F., No. 516, Sec. 1, Neihu Rd. Taipei. Taiwan 11493 REPUBLIC OF CHINA
Re: K202292
Trade/Device Name: UDE Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: LLZ Dated: May 27, 2020 Received: August 12, 2020
Dear Mr. Su:
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
1
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name UDE
Indications for Use (Describe)
UDE software is intended to display images from CT, MR, CR, US, XA and SC for the trained physician 's diagnosis or referring purpose. UDE provides wireless and portable access to medical images. It is not intended to be used as, or to replace, a full diagnostic workstation or system and should be used only when there is no access to a workstation. This device is not to be used for mammography diagnosis.
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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5.1 Device Submitter
EBM Technologies Incorporated 5F., No. 516, Sec. 1, Neihu Rd., Taipei, Taiwan, Republic of China Phone: 886 2 8751 4567 Fax: 886 2 8751 3300 Contact Person: John Su Regulation Affairs Manager Tel: 808. 397.6809 john@ebmtech.com
5.2 Device Name
Device Trade Name: UDE Device Class : Class 2 Product Code : LLZ Regulation name and number: Picture Archiving and Communications System , 21 CFR 892.2050
5.3 Substantially Equivalent (predicate) device(s)
Device Trade Name: EBM iDO Viewer 510(k) Number: K140399 Device Class : Class 2 Product Code : LLZ Regulation name and number: Picture Archiving and Communications System , 21 CFR 892.2050 Manufacturer: EBM Technologies Incorporated
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5.4 Device Description:
UDE is a software device that can be installed on Apple iPad Pro. Through wireless network, user can login, query and display the images which are stored in heir existing UDE server. The device can be installed in iOS 9, 11, 12 and 13 version platform such as iPad /iPhone, but can't be installed in platforms other than iOS 9, 11, 12 and 13 version . The image display quality on iPad /iPhone will be almost the same as on iPad Pro when it is used for diagnosis purpose of CT, MR, US, XA and SC. However, if it is used for CR diagnosis purpose, we will strongly suggest that users should adopt iPad Pro. because the screen size of iPad Pro is larger than those of Apple® iPad/iPhone.
Main features of UDE are listed below
- Receive, Store, Retrieve, Display, and Process Digital Images(CT, MR, US, CR, Full- Field . Mammography, XA,SC etc.)
- · The displayed CT, MR, CR,, US,XA and SC images can be diagnosed by the trained physicians.
- . The displayed CT, MR, CR, Full- Field Mammography, US, XA and SC images can be referred by the trained physicians. Mammography images are not for diagnostic use
- · Communication log file
- · Auto delete old images (FIFO)
- · Overlay labels
- · User Authentication
- Display of Clinical Patient Data .
- Distance Calculation
- · layout adjustment (1×1, 2×1, 1×2, 2×2)
- · Pan
- Zoom
- Window Level
- · Cine Loop
- Mammography hanging protocol
5.5 Indication for Use:
UDE software is intended to display images from CT, MR, CR, XA and SC for the trained physician 's diagnosis or referring purpose. UDE provides wireless and portable access to medical images. It is not intended to be used as, or to replace, a full diagnostic workstation or system and should be used only when there is no access to a workstation. This device is not to be used for mammography diagnosis.
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5.6 Technical characteristics
UDE is a software device that can be installed on Apple iPad Pro. Through wireless network, user can login, query and display the images which are stored in heir existing UDE server. It has functions related to the medical image presentation and processing. These functions can help the trained physician to perform the medical images review and diagnosis if environment lighting condition has been evaluated and in opportune setting.
| Device | Subject device | Predicate device | Comparison and
Explanation of
Differences |
|-------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Topic | UDE | EBM iDO Viewer | |
| 510k number | N/A | K140399 | |
| Intended Use /
Indications for Use | UDE software is intended
to display images from
CT, MR , CR, US, XA
and SC for the trained
physician 's diagnosis or
referring purpose. UDE
provides wireless and
portable access to
medical images. It is not
intended to be used as, or
to replace, a full
diagnostic workstation or
system and should be
used only when there is
no access to a
workstation. This device
is not to be used for
mammography diagnosis. | EBM iDO Viewer software is
intended to display images from
CT/MR for the trained physician 's
diagnosis or referring purpose.
EBM iDO Viewer provides
wireless and portable access to
medical images. It is not intended
to be used as, or to replace, a full
diagnostic workstation or system
and should be used only when there
is no access to a workstation. This
device is not to be used for
mammography. | The images displayed by
subject device have extended
to CR and Full-Field
Mammography , US, XA and
SC. It leads to the change of
intended use. It raises no new
issues of safety or
effectiveness |
| Receive, Store,
Retrieve, Display,
and Process Digital
Medical Images | Yes | Yes | No difference |
| Display of Clinical
Patient Data When
No Access to a
Workstation | Yes | Yes | No difference |
| Distance Calculation | Yes | Yes | No difference |
| layout adjustment (1
×1,2×1,1×2,2
×2) | Yes | Yes | No difference |
| Window / Level | Yes | Yes | No difference |
| Zoom, Pan | Yes | Yes | No difference |
| User Authentication | Yes | Yes | No difference |
| Modality images for
diagnosis | CT, MRI, CR, US,
XA,SC | CT, MRI | The images displayed by
subject device has extended to
CR, US, XA, and SC. It raises
no new issues of safety or
effectiveness |
| Modality images for
reference.
Mammography
images are not for
diagnostic use. | CT, MRI, CR, Full-Field
Digital
Mammography, US,
XA,SC | CT, MRI ,US, CR,XA,SC | The modalities connected
with subject device has
extended to Full-Field
Mammography. It raises no
new issues of safety or
effectiveness |
| Mammography
hanging protocol | Yes | No | Subject device has added a
new image process function
which raise no new issues of
safety or effectiveness |
| Communication log
file | Yes | No | Subject device has added a
new image process function
which raise no new issues of
safety or effectiveness |
| Auto delete old
images (FIFO) | Yes | No | Subject device has added a
new image process function
which raise no new issues of
safety or effectiveness |
| Overlay labels | Yes | No | Subject device has added a
new image process function
which raise no new issues of
safety or effectiveness |
| Remote Handheld
Viewing | Yes | Yes | No difference |
| Operating Platform | Apple® iOS | Apple® iOS | No difference |
| Hardware
Requirements | Apple® iPad Pro | Apple® iPad/iPhone | The hardware to be installed is
different. It raises no new
issues of safety or
effectiveness |
| Screen technology | 12.9"/11"TFT Color
LCD Panel | 9.7"TFT Color LCD Panel
(Apple® iPad)
3.5"TFT Color LCD Panel
(Apple® iPhone) | The screen size of iPad Pro is
larger than those of Apple®
iPad/iPhone. It raises no new
issues of safety or
effectiveness |
| Screen resolution in
pixels/square inch | 264 ppi | 264 ppi (Apple® iPad)
326 ppi (Apple® iPhone) | The screen of iPad Pro has the
same resolution as that of
Apple® iPad, but is different
that of iPhone. It raises no new
issues of safety or
effectiveness |
Device Comparison between subject and predicate
6
7
5.7 Performance data from non-clinical Testing
The software verification testing and validation testing based on IEC 62304 workflows have been performed by designed engineer or professional personnel. These testing include unit, integration and system tests. The test results of software verification and validation had all met and passed the acceptance criteria referred to medical image software quality request.
The non-clinical performance of display had been conducted according to the description and requirements described in the AAPM Assessment of Display Performance for Medical Imaging Devices (2005) document by a third party to ensure high quality laboratory results. All tests had passed successfully.
5.8 Performance data from clinical Testing
Given the differences from the predicate device iDO Viewer (K140399), no clinical testing of the UDE software is necessary for this submission. The subject software is based on the cleared predicate. Moreover, bench testing results are showing adequate performance of the iPad Pro display used in combination with the UDE software.
5.9 Conclusion
Based on all above evidence, UDE described in this 510(K) is, in our opinion, substantially equivalent to the predicate devices.