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.

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.

AI/ML Overview

The NubeX device is a Picture Archiving and Communication System (PACS) intended for displaying, communicating, storing, and processing medical images and data. It is substantially equivalent to the predicate device, INFINITT ULite (K163290).

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document is a 510(k) summary for a PACS system, which primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed clinical performance metrics typical of AI/CADe devices. As such, explicit quantitative acceptance criteria (e.g., sensitivity, specificity, AUC) and corresponding reported performance values for diagnostic tasks are not present in this document. The "performance" discussed primarily relates to software functionality and safety, asserting that the device performs as intended and does not introduce new risks.

Acceptance Criteria (Explicitly Stated in the document)	Reported Device Performance
Software Verification and Validation	Complies with IEC 62304:2015
Cybersecurity Verification and Validation	Complies with FDA guidance on Cybersecurity in Medical Devices
Function Test Performance	Passed all in-house pre-determined testing criteria without significant failures. Performs all required actions according to functional requirements with no errors impacting safety or efficacy.

2. Sample Size and Data Provenance

The document does not specify a sample size for a test set (e.g., number of images, patients) or the data provenance (e.g., country of origin, retrospective/prospective). This is because the device, NubeX, is a PACS viewer and not an AI or diagnostic algorithm that would typically require such a clinical test set to evaluate its diagnostic performance. The testing described is primarily software functional testing.

3. Number of Experts and Qualifications for Ground Truth

The document does not mention using experts to establish ground truth for a test set. This type of evaluation is not applicable to a PACS system that primarily handles image display and management, rather than providing a diagnostic interpretation or algorithmic output that needs to be compared against expert consensus or pathological findings.

4. Adjudication Method

Not applicable. No diagnostic test set or expert adjudication is described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. The document does not describe an MRMC study comparing human readers with and without AI assistance, as NubeX is a PACS system and does not provide AI-driven diagnostic assistance.

6. Standalone Performance Study

Not applicable. The device's performance is described in terms of its functional capabilities as a PACS system, not as a standalone diagnostic algorithm. The non-clinical performance data references "function tests" and "software verification and validation," which are evaluations of the system's operational integrity rather than diagnostic accuracy.

7. Type of Ground Truth Used

No clinical ground truth (such as expert consensus, pathology, or outcomes data) was used in the context of diagnostic performance evaluation, as the device is not an AI diagnostic algorithm. The "ground truth" for the non-clinical performance data would be the functional specifications and requirements of the software itself.

8. Sample Size for the Training Set

Not applicable. NubeX is a PACS system, not an AI or machine learning algorithm that requires a training set of medical images for model development.

9. How Ground Truth for the Training Set was Established

Not applicable. As there is no training set for an AI model, there is no ground truth establishment process described for a training set.

Summary

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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

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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

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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)

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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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

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(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).

Among part of image processing, there are different functions than predicated device (INFINITT ULite, K163290).

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.

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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 ProductCode /Regulatory Number	Product code: LLZRegulatory number: 21 CFR892.2050	Product code: LLZRegulatory number: 21 CFR892.2050
Regulatory Class	Class II	Class II
Indications for Use	NubeX, PACS is a softwaredevice that receives medicalimages and data from variousimaging sources. Images anddata can be stored,communicated, processed, anddisplayed within the system oracross computer networks atdistributed locations. Onlypreprocessed DICOM forpresentation images can beinterpreted for primary imagediagnosis in mammography.Lossy compressedmammographic images anddigitized film screen imagesmust not be reviewed forprimary image interpretations.Mammographic images mayonly be interpreted using amonitor that meets technicalspecification identified by FDA.Typical users of this system aretrained professionals, e.gphysicians, radiologists, nurses,and medical technicians.	INFINITT ULite, PACS is asoftware device that receivesmedical images and data fromvarious imaging sources.Images and data can be stored,communicated, processed, anddisplayed within the system oracross computer networks atdistributed locations. Onlypreprocessed DICOM forpresentation images can beinterpreted for primary imagediagnosis in mammography.Lossy compressedmammographic images anddigitized film screen imagesmust not be reviewed forprimary image interpretations.Mammographic images mayonly be interpreted using amonitor that meets technicalspecification identified by FDA.Typical users of this system aretrained professionals, e.gphysicians, radiologists, nurses,and medical technicians.
Technologicalcharacteristics	NubeX, device is a softwareproduct that handles digitalmedical images. Thedevice does not contact thepatient, nor does it control anylife sustaining devices. Aphysician, providing ampleopportunity for competent	INFINITT ULite™ device is asoftware product that handlesdigital medical images. Thedevice does not contact thepatient, nor does it control anylife sustaining devices. Aphysician, providing ampleopportunity for competent
	human intervention interpretsimages and information beingdisplayed and printed.	human intervention interpretsimages and information beingdisplayed and printed.
Software environment	OS: Windows 10 (64bit) /Chrome (64bit) v67 +	OS: over the Microsoft Windows7
Resolution	Minimum specification 32bitColor Display & 1920x1080resolutionRecommend specification 32bitColor Display & 1920x1080 orhigher resolution	1280 x 1024
Main Function	Log inWorklist - Search filterWorklist - Open imageWorklist - exam listWorklist - ReportWorklist - SeriesViewer - View examViewer - Control View-windowViewer – view mode (large)Viewer - view mode (real-resolution)Viewer – view mode(highlight)Viewer - StackingViewer – Changing layoutViewer — Window/LevelingViewer - ComparativestudyViewer - Preset filterViewer – ZoomingViewer - PanningViewer - RotationViewer – Viewing mode(Normal/ Image/ Stack/Custom/ Annotation)Viewer – Advanced imageoperationViewer – Scout lineViewer - SharpeningViewer – AnnotationViewer – Cine	Log inWorklist - Search filterWorklist - multiple selectionWorklist - Open imageWorklist - Series listWorklist - ConfigurationViewer - display imageViewer - multiple seriesViewer - Main tab (exam)Viewer – ToolbarViewer – ThumbnailViewer - Exam listViewer - combine modeViewer - change series listViewer - display layoutViewer - selecting imageViewer - adjust windowwidth/levelViewer – window presetViewer – inverting imagecolorViewer - measureViewer - annotationViewer - Spine labelingViewer – PanViewer - Magnifying GlassViewer – ZoomViewer - Rotation/ FlipViewer - Scout lineViewer - OverlayingViewer - Cine modeViewer - Report
Operation feature	- Web environment based PACS- Viewing and handling DICOMmedical image- Review, modify and approvestudy located in a server	- Web environment based PACS- Viewing and handling DICOMmedical image- Review, modify and approvestudy located in a server
Prescription or OTC	Prescription	Prescription

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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.

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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.

Regulation Number and Section

§ 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).