(57 days)
Not Found.
No
The summary describes standard PACS functionalities, image stacking, and a 3D cursor. There is no mention of AI, ML, or related concepts like deep learning, training data, or performance metrics typically associated with AI/ML algorithms.
No.
This device is a Picture Archiving and Communication System (PACS) software that receives, stores, communicates, processes, and displays medical images. Its primary function is to aid in the diagnosis and interpretation of medical images, not to provide treatment or therapy.
Yes
The device, NubeX, PACS, is explicitly stated to allow preprocessed DICOM images to be interpreted for primary image diagnosis in mammography. This indicates its use in diagnostic processes.
Yes
The device is explicitly described as a "software device" and its functions relate to receiving, storing, communicating, processing, and displaying medical images and data. While it interacts with imaging sources and monitors, the core device being submitted for 510(k) is the software itself.
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 NubeX is a software device that receives, stores, communicates, processes, and displays medical images and data from various imaging sources (like X-ray, CT, MRI, etc.). It is a Picture Archiving and Communication System (PACS).
- Lack of Biological Sample Analysis: There is no mention of the device analyzing biological samples or performing any tests on them. Its function is centered around managing and displaying medical images.
Therefore, NubeX falls under the category of medical imaging software, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
NubeX, PACS is a software device that receives medical images and data from various imaging sources. Images and data can be stored, communicated, processed, and displayed within the system or across computer networks at distributed locations. Only preprocessed DICOM for presentation images can be interpreted for primary image diagnosis in mammography.
Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using a monitor that meets technical specification identified by FDA. Typical users of this system are trained professionals, e.g physicians, radiologists, nurses, and medical technicians.
Product codes (comma separated list FDA assigned to the subject device)
LLZ
Device Description
NubeX is a based on the predicated Picture Archiving and Communication system (PACS) device (INFINITT ULite, K163290).
NubeX is for displays medical images and data from various imaging sources, and from other healthcare information sources. Medical images and data can be displayed, communicated, stored, and processed.
Among part of image processing, there are different functions than predicated device (INFINITT ULite, K163290).
In NubeX, provide image stacking function and 3D cursor function. In case of stacking, after putting the mouse point on an image, you can use the mouse wheel to view the previous or next image of the current one in the series. Stacking shows images within the series. Thus, although the last image currently shows up and the mouse wheel moves down, the last image does not get changed.
In case of 3D cursor, after turning on the "3D Cursor" button and selecting an image or stack window, if you use the mouse left button to click and drag on the image, you can see the "X" mark and move the mark to any direction. At that time, you can see the images which are on the mark point in the 3D space. For example, when you click and drag on a sagittal image, you can see the images axial images that are on the mark point in the 3D space.
Other than that, the functions basically provided as PACS are the same as those of predicated devices and the additional PACS features don't present any risk to device safety.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found.
Input Imaging Modality
Medical images and data from various imaging sources.
Anatomical Site
Not Found.
Indicated Patient Age Range
Not Found.
Intended User / Care Setting
Typical users of this system are trained professionals, e.g physicians, radiologists, nurses, and medical technicians.
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 performance data relied on this premarket notification submission for a determination of substantial equivalence include testing showing compliance with the following standards:
- Software Verification and Validation IEC 62304:2015, Medical Device Software - Software Life Cycle Processes
- Cybersecurity Verification and Validation FDA guidance, Content of Premarket Submissions for Management of Cybersecurity in Medical Devices
- Function Test
Internal Standards, The complete system configuration has been tested at the factory and the device has passed all in-house pre-determined testing criteria without significant failures. The data presented in the submission demonstrates that NubeX performs all required actions according to the functional requirements specified in the Software Requirements Specification and the User Manual with no errors that had an impact on safety or efficacy.
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).
0
July 8, 2021
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 square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
TechHeim Co., Ltd. % Mr. JeongKeun Kim RA Consultant KMC, Inc. Room no. 1709, 123, Digital-ro 26-gil, Guro-gu SEOUL. 08390 SOUTH KOREA
Re: K211480
Trade/Device Name: NubeX Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: LLZ Dated: May 6, 2021 Received: May 12, 2021
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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K211480
Device Name NubeX
Indications for Use (Describe)
NubeX, PACS is a software device that receives medical images and data from various imaging sources. Images and data can be stored, communicated, processed, and displayed within the system or across computer networks at distributed locations. Only preprocessed DICOM for presentation images can be interpreted for primary image diagnosis in mammography.
Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using a monitor that meets technical specification identified by FDA. Typical users of this system are trained professionals, e.g physicians, radiologists, nurses, and medical technicians.
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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3
510(k) SUMMARY
K211480
This summary of 510(k) -safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.
Date: Jun 09, 2021
1. INFORMATION
1.1 Submitter Information
- . Submitter Name: TechHeim Co., Ltd
- . Address
- : 21, Banpo-daero 24-gil, Seocho-gu, Seoul, 06648, Republic of Korea
- Telephone Number: +82-2-2028-0733 . ▪ Fax: +82-2-2028-0734
- . E-mail: wylee@techheim.com
1.2 Contact Person
- . Name: JeongKeun Kim (RA Consultant / KMC, Inc.)
- . Address: Room 1709, 123, Digital-ro 26-gil, Guro-gu, Seoul, 08390, Republic of Korea
- . Telephone Number: +82-70-8965-5554 . Fax: +82-2-2672-0579
- . E-mail: jkkim@kmcerti.com
2. DEVICE INFORMATION
- 2.1 Trade Name / Proprietary Name: NubeX
- 2.2 Regulation Name: Medical Image Management and Processing System.
- 2.3 Classification Name: system, image processing, radiological
- 2.4 Product Code: LLZ
- 2.5 Regulation number: 21 CFR892.2050
- 2.6 Device Class: Class II
- 2.7 Classification Panel: Radiology
3. PREDICATE DEVICE
| Manufacturer | INFINITT CO., LTD. |
|---|---|
| Device Name | INFINITT ULite |
4
| (Trade Name) | |
|---|---|
| 510(k) Number | K163290 |
| Regulation name | Picture archiving and communications system |
| Regulation number | 21 CFR892.2050 |
| Product code | LLZ |
| Classification | Class II |
4. SUBJECT DEVICE DESCRIPTION
NubeX is a based on the predicated Picture Archiving and Communication system (PACS) device (INFINITT ULite, K163290).
NubeX is for displays medical images and data from various imaging sources, and from other healthcare information sources. Medical images and data can be displayed, communicated, stored, and processed.
Among part of image processing, there are different functions than predicated device (INFINITT ULite, K163290).
In NubeX, provide image stacking function and 3D cursor function. In case of stacking, after putting the mouse point on an image, you can use the mouse wheel to view the previous or next image of the current one in the series. Stacking shows images within the series. Thus, although the last image currently shows up and the mouse wheel moves down, the last image does not get changed.
In case of 3D cursor, after turning on the "3D Cursor" button and selecting an image or stack window, if you use the mouse left button to click and drag on the image, you can see the "X" mark and move the mark to any direction. At that time, you can see the images which are on the mark point in the 3D space. For example, when you click and drag on a sagittal image, you can see the images axial images that are on the mark point in the 3D space.
Other than that, the functions basically provided as PACS are the same as those of predicated devices and the additional PACS features don't present any risk to device safety.
5. INTENDED USE
NubeX is a Picture Archiving and Communication system (PACS) for displays medical images and data from various imaging sources, and from other healthcare information sources. Medical images and data can be displayed, communicated, stored, and processed.
Typical users of this system are trained professionals such as physicians, radiologists, radiographer, and other qualified medical professionals.
5
6. SUBSTANTIAL EQUIVALENCE
NubeX is substantially equivalent to the predicate devices (INFINITT ULite, K163290).
The following table is presented to demonstrate substantial equivalence.
| Subject Device | Predicate Device | |
|---|---|---|
| Manufacturer | TechHeim Co., Ltd | INFINITT CO., LTD. |
| Device Name | NubeX | INFINITT ULite |
| 510(k) number | K211480 | K163290 |
| Classification Product | ||
| Code / | ||
| Regulatory Number | Product code: LLZ | |
| Regulatory number: 21 CFR | ||
| 892.2050 | Product code: LLZ | |
| Regulatory number: 21 CFR | ||
| 892.2050 | ||
| Regulatory Class | Class II | Class II |
| Indications for Use | NubeX, PACS is a software | |
| device that receives medical | ||
| images and data from various | ||
| imaging sources. Images and | ||
| data can be stored, | ||
| communicated, processed, and | ||
| displayed within the system or | ||
| across computer networks at | ||
| distributed locations. Only | ||
| preprocessed DICOM for | ||
| presentation images can be | ||
| interpreted for primary image | ||
| diagnosis in mammography. | ||
| Lossy compressed | ||
| mammographic images and | ||
| digitized film screen images | ||
| must not be reviewed for | ||
| primary image interpretations. | ||
| Mammographic images may | ||
| only be interpreted using a | ||
| monitor that meets technical | ||
| specification identified by FDA. | ||
| Typical users of this system are | ||
| trained professionals, e.g | ||
| physicians, radiologists, nurses, | ||
| and medical technicians. | INFINITT ULite, PACS is a | |
| software device that receives | ||
| medical images and data from | ||
| various imaging sources. | ||
| Images and data can be stored, | ||
| communicated, processed, and | ||
| displayed within the system or | ||
| across computer networks at | ||
| distributed locations. Only | ||
| preprocessed DICOM for | ||
| presentation images can be | ||
| interpreted for primary image | ||
| diagnosis in mammography. | ||
| Lossy compressed | ||
| mammographic images and | ||
| digitized film screen images | ||
| must not be reviewed for | ||
| primary image interpretations. | ||
| Mammographic images may | ||
| only be interpreted using a | ||
| monitor that meets technical | ||
| specification identified by FDA. | ||
| Typical users of this system are | ||
| trained professionals, e.g | ||
| physicians, radiologists, nurses, | ||
| and medical technicians. | ||
| Technological | ||
| characteristics | NubeX, device is a software | |
| product that handles digital | ||
| medical images. The | ||
| device does not contact the | ||
| patient, nor does it control any | ||
| life sustaining devices. A | ||
| physician, providing ample | ||
| opportunity for competent | INFINITT ULite™ device is a | |
| software product that handles | ||
| digital medical images. The | ||
| device does not contact the | ||
| patient, nor does it control any | ||
| life sustaining devices. A | ||
| physician, providing ample | ||
| opportunity for competent | ||
| human intervention interprets | ||
| images and information being | ||
| displayed and printed. | human intervention interprets | |
| images and information being | ||
| displayed and printed. | ||
| Software environment | OS: Windows 10 (64bit) / | |
| Chrome (64bit) v67 + | OS: over the Microsoft Windows | |
| 7 | ||
| Resolution | Minimum specification 32bit | |
| Color Display & 1920x1080 | ||
| resolution | ||
| Recommend specification 32bit | ||
| Color Display & 1920x1080 or | ||
| higher resolution | 1280 x 1024 | |
| Main Function | Log in | |
| Worklist - Search filter | ||
| Worklist - Open image | ||
| Worklist - exam list | ||
| Worklist - Report | ||
| Worklist - Series | ||
| Viewer - View exam | ||
| Viewer - Control View- | ||
| window | ||
| Viewer – view mode (large) | ||
| Viewer - view mode (real- | ||
| resolution) | ||
| Viewer – view mode | ||
| (highlight) | ||
| Viewer - Stacking | ||
| Viewer – Changing layout | ||
| Viewer — Window/Leveling | ||
| Viewer - Comparative | ||
| study | ||
| Viewer - Preset filter | ||
| Viewer – Zooming | ||
| Viewer - Panning | ||
| Viewer - Rotation | ||
| Viewer – Viewing mode | ||
| (Normal/ Image/ Stack/ | ||
| Custom/ Annotation) | ||
| Viewer – Advanced image | ||
| operation | ||
| Viewer – Scout line | ||
| Viewer - Sharpening | ||
| Viewer – Annotation | ||
| Viewer – Cine | Log in | |
| Worklist - Search filter | ||
| Worklist - multiple selection | ||
| Worklist - Open image | ||
| Worklist - Series list | ||
| Worklist - Configuration | ||
| Viewer - display image | ||
| Viewer - multiple series | ||
| Viewer - Main tab (exam) | ||
| Viewer – Toolbar | ||
| Viewer – Thumbnail | ||
| Viewer - Exam list | ||
| Viewer - combine mode | ||
| Viewer - change series list | ||
| Viewer - display layout | ||
| Viewer - selecting image | ||
| Viewer - adjust window | ||
| width/level | ||
| Viewer – window preset | ||
| Viewer – inverting image | ||
| color | ||
| Viewer - measure | ||
| Viewer - annotation | ||
| Viewer - Spine labeling | ||
| Viewer – Pan | ||
| Viewer - Magnifying Glass | ||
| Viewer – Zoom | ||
| Viewer - Rotation/ Flip | ||
| Viewer - Scout line | ||
| Viewer - Overlaying | ||
| Viewer - Cine mode | ||
| Viewer - Report | ||
| Operation feature | - Web environment based PACS |
- Viewing and handling DICOM
medical image - Review, modify and approve
study located in a server | - Web environment based PACS - Viewing and handling DICOM
medical image - Review, modify and approve
study located in a server |
| Prescription or OTC | Prescription | Prescription |
6
7
6.1 Difference between the subject device and the predicates devices
1) Software environment
: The subject device has a different software O.S and web environment.
This difference does not raise any problems in the safety and effectiveness when we use NubeX for displays medical images and data from various imaging sources, and from other healthcare information sources.
Medical images and data can be displayed, communicated, stored, and processed.
2) Resolution
: The subject device has a different displayed resolution.
The result show that these difference does not raise any problem for displays medical images and data from various imaging sources, and from other healthcare information sources. Medical images and data can be displayed, communicated, stored, and processed in the safety and effectiveness.
6.2 Equivalence between the subject device and the predicates devices
1) Product code
: The proposed product code of the subject device is "LLZ". It is the same classification name as the predicate device.
2) Indications for use
: For indications for use, NubeX is a Picture Archiving and Communication system (PACS) for displays medical images and data from various imaging sources, and from other healthcare information sources. Medical images and data can be displayed, communicated, stored, and processed.
Typical users of this system are trained professionals such as physicians, radiologists, radiographer, and other qualified medical professionals.
3) Function
: Both devices (subject device and predicate device) are composition to Worklist and Viewer to show the Medical images and data which can be displayed, communicated, stored, and processed.
4) Operation feature
: Both devices (subject device and predicate device) are operated by web PACS environment for displays medical images and data from various imaging sources, and from other healthcare information sources through the DICOM.
5) Prescription or OTC
: Both devices (subject device and predicate device) are prescription medical device. It is the same.
8
7. Performance Data
The following performance data were provided to support the substantial equivalence determination.
Non-clinical performance data
Non-clinical tests relied on this premarket notification submission for a determination of substantial equivalence include testing showing compliance with the following standards:
- Software Verification and Validation IEC 62304:2015, Medical Device Software - Software Life Cycle Processes
- · Cybersecurity Verification and Validation FDA quidance, Content of Premarket Submissions for Management of Cybersecurity in Medical Devices
- Function Test
Internal Standards,
The complete system configuration has been tested at the factory and the device has passed all in-house pre-determined testing criteria without significant failures. The data presented in the submission demonstrates that NubeX performs all required actions according to the functional requirements specified in the Software Requirements Specification and the User Manual with no errors that had an impact on safety or efficacy.
8. CONCLUSION
Under the comparing substantial equivalence between the subject device and the predicate device, there are the same points such as product code, indications for use, operation, performance and technological characteristics.
Although there are some differences (Software environment, Language, Resolution), the device function and internal test (function test) are supported to the safety and effectiveness of the subject device.
In this regard, we conclude that the subject device is substantially equivalent to the predicate device.