K Number
K241694
Device Name
ZeTTA PACS
Date Cleared
2025-01-31

(233 days)

Product Code
Regulation Number
892.2050
Reference & Predicate Devices
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

ZeTTA PACS is intended for use in hospitals and diagnostic centers as a PACS to receive, store, retrieve, and display medical images from DICOM-compliant modalities, including CT, MRI, ultrasound, and radiographic devices. The system enables healthcare professionals to securely access and analyze diagnostic images over hospital networks.

Typical users of ZeTTA PACS include trained professionals such as physicians, radiologists, and medical technicians.

For mammography, 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 specifications identified by FDA.

Device Description

ZeTTA PACS is a Windows-based Picture Archiving and Communication System (PACS) used in hospitals and diagnostic centers to receive, store, retrieve, distribute, and display medical images from various DICOMcompliant modalities, such as CT, MRI, ultrasound, and radiographic devices. This system supports the DICOM 3.0 standard and is designed to allow healthcare professionals to securely access and manage medical images over hospital networks.

ZeTTA PACS supports more than two high-resolution monitors to facilitate efficient image interpretation. It provides advanced layout options, multi-worklist functionality, and DICOM GSPS (Grayscale Presentation State), enhancing diagnostic and analytical efficiency. Additionally, it offers image analysis tools such as ruler and angle, along with image manipulation features like windowing and zoom, enabling healthcare professionals to perform more accurate analyses.

ZeTTA PACS integrates multiple medical imaging sources into a centralized solution, ensuring secure storage and management. It is useful across various medical fields such as radiology, and neurology. However, it does not provide diagnostic decision-making functions, and all diagnoses, treatments, and prescriptions must be made by qualified medical professionals.

Furthermore, ZeTTA PACS does not support mobile devices and is designed for use in network-based desktop and workstation environments, ensuring stable and secure management of medical images.

AI/ML Overview

The provided document describes the ZeTTA PACS, a medical image management and processing system, and its substantial equivalence to a predicate device. However, the document does not contain an acceptance criteria table or a detailed study proving the device meets specific acceptance criteria in the manner requested.

The "Determination of Substantial Equivalence" section in the K241694 submission (page 6-7) compares the proposed device (ZeTTA PACS) to the predicate device (Infinitt PACS 7.0) based on various features and functionalities. This comparison is used to argue for substantial equivalence, not to demonstrate performance against pre-defined quantitative acceptance criteria for things like diagnostic accuracy or sensitivity/specificity.

Here's an analysis based on the information provided, highlighting what is present and what is missing:

1. A table of acceptance criteria and the reported device performance

  • Not present in the requested format. The document provides a detailed comparison table between the proposed device and its predicate, outlining functionalities like worklist modes, study list features, image display options, and output capabilities. It consistently concludes "Same" for these features, indicating functional equivalence, but it does not present quantitative performance metrics against specific acceptance criteria.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

  • Not present. The document mentions "Performance Testing" was conducted, confirming that "ZeTTA PACS meets all performance test criteria and that all functions work without errors." However, it does not specify the sample size of images or cases used for this testing, nor does it provide details about the data provenance (e.g., country of origin, retrospective/prospective nature).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

  • Not applicable/Not present. Since a clinical performance study with an explicit ground truth assessment by experts is not described for the ZeTTA PACS itself, this information is not provided. The device is a PACS system for managing and viewing images, not an AI-powered diagnostic tool that produces interpretations.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

  • Not applicable/Not present. For the same reasons as point 3, an adjudication method for a test set's ground truth is not relevant or provided in this context.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

  • Not present. The device described (ZeTTA PACS) is a Picture Archiving and Communication System; it does not explicitly feature AI-assisted diagnostic capabilities. Therefore, an MRMC study comparing human readers with and without AI assistance is not described.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

  • Not applicable/Not present. ZeTTA PACS is a software system for image management and display, not a standalone diagnostic algorithm. Its function is to facilitate human interpretation, not to provide independent diagnostic outputs.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

  • Not applicable/Not present. As this is a PACS system and not an AI diagnostic device, the concept of "ground truth" for diagnostic accuracy is not directly applicable to its stated function in this submission. The tests performed were likely functional and performance tests to ensure the system handles images correctly, displays them accurately, and supports its specified features.

8. The sample size for the training set

  • Not applicable/Not present. ZeTTA PACS is not described as an AI/ML-driven device requiring a training set in the way a diagnostic algorithm would. It is a traditional software system for image management.

9. How the ground truth for the training set was established

  • Not applicable/Not present. For the same reason as point 8, this information is not relevant or provided.

Summary of what is available regarding "acceptance criteria" and "study":

The document focuses on demonstrating substantial equivalence to an existing predicate device (Infinitt PACS 7.0) based on functional and technical characteristics.

  • "Acceptance Criteria" (Implicit): The implicit acceptance criteria appear to be the functionalities and performance of the predicate device, or general industry standards for PACS systems. The comparison table (pages 6-7) outlines the features of both the proposed and predicate devices, and the consistent "Same" in the "SE Decision" column indicates that the proposed device meets these functional requirements.
  • "Study" (Performance Testing): "Performance Testing" was conducted to confirm that "ZeTTA PACS meets all performance test criteria and that all functions work without errors." (Page 9, "Non-Clinical Test Summary"). This implies internal testing was performed to ensure the software's functionality, stability, and adherence to design specifications. However, specific test methodologies, quantitative results, or external validation studies are not detailed.
  • No Clinical Studies: The document explicitly states, "No clinical studies were considered necessary and performed." (Page 9, "Clinical Test Summary"). This further confirms that no studies involving human subjects for diagnostic accuracy or effectiveness were part of this submission.

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol representing the Department of Health & Human Services. To the right of the symbol, there is a blue square with the letters "FDA" in white. Next to the blue square, the words "U.S. FOOD & DRUG ADMINISTRATION" are written in blue.

Tae Young Soft Co., Ltd. Gee Yun Hong Staff B-1504. B1505, 65, Gwacheon-daero 7-gil Gwacheon-si, 13840 Korea. South

January 31, 2025

Re: K241694

Trade/Device Name: ZeTTA PACS Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management And Processing System Regulatory Class: Class II Product Code: LLZ Dated: December 24, 2024 Received: December 26, 2024

Dear Gee Yun Hong:

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 (the 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 available 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.

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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (OS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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

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(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.

Jessica Lamb

Jessica Lamb Assistant Director Imaging Software Team DHT8B: Division of Radiologic Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

Submission Number (if known)

K241694

Device Name

Zetta PACS

Indications for Use (Describe)

ZeTTA PACS is intended for use in hospitals and diagnostic centers as a PACS to receive, store, retrieve, and display medical images from DICOM-compliant modalities, including CT, MRI, ultrasound, and radiographic devices. The system enables healthcare professionals to securely access and analyze diagnostic images over hospital networks.

Typical users of ZeTTA PACS include trained professionals such as physicians, radiologists, and medical technicians.

For mammography, only preprocessed DICOM for-presentation images can be interpreted for primary image diagnosis in mammoaraphy. 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 specifications identified by FDA.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

he-Counter Use (21 CFR 801 Subpart C)

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Image /page/4/Picture/1 description: The image contains a logo for "Tysoft TaeYoung Soft". The logo features a stylized letter "T" enclosed within a circular design, with the text "TYSOFT" appearing to the right of the symbol. Below "TYSOFT" is the text "TaeYoung Soft".

510(k) Summary

[As required by 21 CFR 807.92]

1. Date Prepared [21 CFR 807.92(a)(a)]

January 31, 2025

2. Submitter's Information & Contact Person [21 CFR 807.92(a)(1)]

  • Name of Manufacturer: Tae Young Soft Co., Ltd.

  • Address: B-1504. B1505, 65, Gwacheon-daero 7-gil Gwacheon-si, Gyeonggi-do, 13840 Republic of Korea / Tel: 82-2-852-5500 - Contact Name: Gee Yun Hong - Telephone No.: +82 10 2708-0699 - Fax No.: +82-02-3434-3119 - Email Address: gyoonh@tysoft.co.kr

Trade Name, Common Name, Classification [21 CFR 807.92(a)(2)| 3.

Trade name: ZeTTA PACS

Classification Description21 CFR SectionProduct Code
Medical image management and processing system892.2050LLZ

As stated in 21 CFR, parts 872.5470 and 892.2050, this generic type of devices has been classified as Class II.

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Image /page/5/Picture/0 description: The image contains the logo for TYSoft. The logo features a stylized letter "T" enclosed within a circular design, accompanied by the text "TYSOFT" in bold, blue letters. Below "TYSOFT" is the text "TaeYoung Soft" in a smaller font size and lighter shade of blue.

Identification of Predicate Device(s) [21 CFR 807.92(a)(3)[ 4.

The identified predicate devices within this submission are shown as follow:

Predicate device #1

  • . 510(k) Number: K172803
  • Applicant: Infinitt Healthcare Co., Ltd.
  • Classification Name: Medical image management and processing system ●
  • Trade Name: ● Infinitt PACS 7.0

ನ. Description of the Device [21 CFR 807.92(a)(4)]

ZeTTA PACS is a Windows-based Picture Archiving and Communication System (PACS) used in hospitals and diagnostic centers to receive, store, retrieve, distribute, and display medical images from various DICOMcompliant modalities, such as CT, MRI, ultrasound, and radiographic devices. This system supports the DICOM 3.0 standard and is designed to allow healthcare professionals to securely access and manage medical images over hospital networks.

ZeTTA PACS supports more than two high-resolution monitors to facilitate efficient image interpretation. It provides advanced layout options, multi-worklist functionality, and DICOM GSPS (Grayscale Presentation State), enhancing diagnostic and analytical efficiency. Additionally, it offers image analysis tools such as ruler and angle, along with image manipulation features like windowing and zoom, enabling healthcare professionals to perform more accurate analyses.

ZeTTA PACS integrates multiple medical imaging sources into a centralized solution, ensuring secure storage and management. It is useful across various medical fields such as radiology, and neurology. However, it does not provide diagnostic decision-making functions, and all diagnoses, treatments, and prescriptions must be made by qualified medical professionals.

Furthermore, ZeTTA PACS does not support mobile devices and is designed for use in network-based desktop and workstation environments, ensuring stable and secure management of medical images.

Indications for Use [21 CFR 807.92(a)(5)] 6.

ZeTTA PACS is intended for use in hospitals and diagnostic centers as a PACS to receive, store, retrieve, and display medical images from DICOM-compliant modalities, including CT, MRI, ultrasound, and radiographic devices. The system enables healthcare professionals to securely access and analyze diagnostic images over hospital networks.

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Image /page/6/Picture/0 description: The image shows the logo for TYsoft. The logo features a stylized letter "T" in a light blue color, surrounded by a curved design. To the right of the symbol, the text "TYSOFT" is written in a bold, dark blue font. Below "TYSOFT", the words "TaeYoung Soft" are written in a smaller, light blue font.

Typical users of ZeTTA PACS include trained professionals such as physicians, radiologists, and medical technicians.

For mammography, 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 specifications identified by FDA.

7. Determination of Substantial Equivalence [21 CFR 807.92(a)(6) and 21 CFR 807.92(b)]

There are no significant differences between Align Studio and the predicate devices that would adversely affect the use of the product. It is substantially equivalent to this device in design, function, and technical characteristics.

Proposed DevicePredicate Device #1SE Decision
K Number-K172803-
ManufacturerTAE YOUNG SOFT CO., LTDInfinitt Healthcare Co., Ltd.-
ModelZeTTA PACSInfinitt PACS 7.0-
Indication forUseZeTTA PACS is developed and designed forthe confirmation, storage, and maintenance ofmedical images used for diagnosis withinhospitals. It is a DICOM viewer based onWindows OS, enabling the storage, zooming,viewing, and transmission of medical images,as well as report generation. ZeTTA PACSincludes DICOM store, DICOMquery/retrieve, and DICOM print modulesthat support the DICOM standard. Itsimultaneously supports two high-resolutionmonitors of FHD or higher and providesWorklist functionality for efficientdiagnostics.Typical users of this system are trainedprofessionals, e.g. physicians, radiologists,nurses, and medical technicians.Infinitt PACS 7.0 is a software devicethat receives medical images and datafrom various imaging sources. Image anddata can be stored, communicated,processed, and displayed within thesystem or across computer networks atdistributed locations.Only preprocessed mammographic imagesand digitized film screen images must notbe reviewed for primary imageinterpretations. Mammographic imagesmay only be interpreted using a monitorthat meet technical specification identifiedby FDA. Typical users of this system aretrained professionals.Same
Imports scanned image of patientImports scanned image of patient
ModuleStand-alone software moduleStand-alone software moduleSame
Support Built-in report moduleSupport Built-in report module
Proposed DevicePredicate Device #1SE Decision
Managing patientand case base dataCreating, editing, deleting and copying patient dataCreating, editing, deleting and copying patient dataSame
WorklistSupports various worklist mode.• Study list• DICOM QR• DICOM DIR• Case• Conference• Technician worklist• Viewed historySupports short cut button for the specific folders ofeach worklist mode (Quickaccess)Supports various worklist mode.• Study list• Favorite folder• DICOM QR• DICOM DIR• Case• Conference• Technician worklist• Embedded webbrowser• Viewed historySupports short cut button for the specificfolders of each worklist mode (Quickaccess)Same
Support open the DICOM files directly (local open)Support open the DICOM files directly (localopen)
Study list• Searches the exams that meet the multiple searchconditions• Exam list displays various information describingthe exams.• Add, delete, change position and sort of eachinformation with header column control• Supports create/edit/delete search folders thatcontains the predefined search conditions• Caches the images to the local disk with On-Callfunction• Exam list are configurable – font name, size,color• Launches the 3rd party application or web URLwith selected examinformation using External link• Opens only key images in the selected exam• Scans documents and attaches to the selectedexam• Supports creating and view the comments of thestudy for private-use or sharing with specified userlevel.• Assigns the priority of the study• Creates and shows technician note• Searches the historical exams of the selectedexam• Creates and shows the report of the selectedexam• Searches the exams that meet the multiplesearch conditions• Configurable fetching count for the exams.• Exam list displays various informationdescribing the exams.• Add, delete, change position and sort of eachinformation with header column control• Supports refreshing the exam listautomatically by user configuration• Exports the list of the selected exams to textfile or MS Excel compatible file(CSV)• Supports create/edit/delete search foldersthat contains the predefined search conditions• Caches the images to the local disk with On-Call function• Exam list are configurable – font name, size,color• Changes exam status using hospital specificterminology• Launches the 3rd party application or webURL with selected exam information usingExternal link• Opens an exam or multiple exams in oneclick• Opens only key images in the selected exam• Scans documents and attaches to the selectedexamSame
Proposed DevicePredicate Device #1SE Decision
• Supports creating and view the comments ofthe study for private-use or sharing withspecified user level.rule, Folder Lock)
• Assigns the priority of the study
• Assigns the referring doctor of the study
• Assigns the Radiologist (Read doctor) of thestudy
• Creates and shows technician note
• Creates and shows ER note
• Searches the historical exams of the selected exam
• Creates and shows the report of the selected exam
Searches order and exam list• Modifies the information of the exam or theseriesSearches order and exam List• Matches or un-matches the selected orderand exams• Merges or un-merges the exam• Splits the series from the exam to new one• Modifies the information of the exam or theseriesSame
Embedded webbrowserBrowses the web pages with predefined web URLBrowses the web pages with predefined webURL
DashboardQueries the number of exams that are met thespecified condition.• Shows the study list that are met the specifiedconditionsQueries the number of exams that are met thespecified condition.• Shows the study list that are met thespecified conditions
General Viewing• Displays the DICOM images which are stored inPACS storage• Accesses historical exams and report: Exam list• Supports image arrangement andmanipulation using toolbar buttons, shortcut keysor screen shortcut• Support user-configurable mouse button action• Configures the initial settings for each specificmodality• Supports job saving• Export or convert the displayed images asDICOM or general image formats• Displays the DICOM images which arestored in PACS storage• Accesses historical exams and report:Timeline, Exam list• Supports image arrangement andmanipulation using toolbar buttons, shortcutkeys or screen shortcut• Support user-configurable mouse buttonaction• Configures the initial settings for eachspecific modality• Supports job saving• Export or convert the displayed images asDICOM or general image formatsSame
Image Display• Maximize and restore displayed image• Support linked scrolling by manual-selection• Support monitor cine control for stack mode• Sets as key image• Supports sequence display (Position/Time) forspecific data• Support display mode:Stack / Image / Preset (VR/MPR/MIP / WebURL /Report)• Maximize and restore displayed image• Support crosslink among the series in samestudy
Proposed DevicePredicate Device #1SE Decision
even for difference exams• Support linked scrolling by manual-selection• Support monitor cine control for stack mode• Sets as key image• Rearranges the images by image information(Sort): image time/number/echo time/imageposition• Supports sequence display (Position/Time)for specific data
Output• Prints the images and report with paper orDICOM printer• Sends the images and report to DICOM station• Various layout adjustment• Report prints with output template which isconfigurable for specific hospital• Selects images for printing• Prints images with or without patientinformation, annotations and scale bar• Prints the images and report with paper orDICOM printer• Sends the images and report to DICOMstation• Export the images and report to MSPowerPoint• Various layout adjustment• Report prints with output template which isconfigurable for specific hospital• Selects images for printing• Prints images with or without patientinformation, annotations and scale bar

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Image /page/7/Picture/0 description: The image contains a logo for TYSOFT TaeYoung Soft. The logo features a stylized letter "T" enclosed within a circular design, positioned to the left of the text "TYSOFT". Below "TYSOFT" is the text "TaeYoung Soft" in a smaller font size. The color scheme is primarily blue.

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Image /page/8/Picture/0 description: The image shows the logo for TYSOFT TaeYoung Soft. The logo features a stylized letter T enclosed within a circular design, both rendered in a vibrant blue color. To the right of the emblem, the text "TYSOFT" is displayed in a bold, sans-serif font, also in blue. Below "TYSOFT", the words "TaeYoung Soft" are written in a smaller, lighter blue font, completing the company's branding.

B-1504. B1505, 65, Gwacheon-daero 7-gil Gwacheon-si, Gyeonggi-do, 13840 Republic of Korea

+82-2-852-5500 | gyoonh@tysoft.co.kr | taeyoungsoft.com

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Image /page/9/Picture/0 description: The image shows the logo for TYSOFT TaeYoung Soft. The logo features a stylized letter "T" enclosed within a circular design, with the company name "TYSOFT" displayed in bold, blue letters to the right of the symbol. Below "TYSOFT" is the text "TaeYoung Soft" in a smaller font size and a lighter shade of blue.

B-1504. B1505, 65, Gwacheon-daero 7-gil Gwacheon-si, Gyeonggi-do, 13840 Republic of Korea

+82-2-852-5500 | gyoonh@tysoft.co.kr | taeyoungsoft.com

Non-Clinical Test Summary [21 CFR 807.92(b)(1)]

1) Software Validation

ZeTTA PACS contains Basic Documentation Level software. Software was designed and developed according to a software development process and was verified and validated.

The software information is provided in accordance with FDA guidance: Content of premarket submissions for Device Software Functions, on November 04, 2021.

    1. Performance Testing
      Through the performance test, it was confirmed that ZeTTA PACS meets all performance test criteria and that all functions work without errors. Test results support the conclusion that actual device performance satisfies the design intent and is equivalent to its predicate device.

Clinical Test Summary [21 CFR 807.92(b)(2)]

No clinical studies were considered necessary and performed.

Conclusion [21 CFR 807.92(b)(3)]

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Image /page/10/Picture/0 description: The image contains the logo for TYsoft. The logo features a stylized letter "T" enclosed within a circular design, accompanied by the text "TYsoft" in a bold, sans-serif font. Below "TYsoft" is the text "TaeYoung Soft" in a smaller font size.

Based on a comparison of intended use, indications, principle of operations, features and technical data, and the test results, the ZeTTA PACS is found to be as safe and as effective as the predicate device. Intended use and performance is found to be substantially equivalent to the predicate device, Infinitt PACS 7.0 tm (K172803) from Infinitt Healthcare Co., Ltd.

§ 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).