(233 days)
Not Found
No
The document describes a standard PACS system with image viewing and manipulation tools, but there is no mention of AI or ML capabilities for image analysis or decision support.
No
This device is a Picture Archiving and Communication System (PACS) used to manage medical images; it does not directly treat or diagnose a disease or condition in a patient.
No
Explanation: The device is a PACS (Picture Archiving and Communication System) that primarily receives, stores, retrieves, and displays medical images. While it provides tools for image analysis and manipulation to aid healthcare professionals in their analyses, it explicitly states, "it does not provide diagnostic decision-making functions, and all diagnoses, treatments, and prescriptions must be made by qualified medical professionals." This indicates it is a tool for image management and viewing, not a diagnostic device itself.
Yes
The device is described as a Windows-based Picture Archiving and Communication System (PACS) that receives, stores, retrieves, distributes, and displays medical images. While it interacts with hardware (monitors, network infrastructure, modalities), the core functionality and the device itself are software running on a standard computing platform. The description focuses entirely on the software features and capabilities.
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.
- ZeTTA PACS deals with medical images generated by imaging modalities (CT, MRI, ultrasound, X-ray). These are not biological specimens.
- The intended use and device description clearly state its purpose is to receive, store, retrieve, and display medical images. It facilitates the management and viewing of images, not the analysis of biological samples.
- The device description explicitly states it "does not provide diagnostic decision-making functions." While it aids in the diagnostic process by providing tools for image analysis, the diagnosis itself is made by a qualified medical professional based on the images.
Therefore, ZeTTA PACS falls under the category of medical imaging software or a Picture Archiving and Communication System (PACS), which is distinct from an In Vitro Diagnostic device.
N/A
Intended Use / Indications for 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.
Product codes
LLZ
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
DICOM-compliant modalities, including CT, MRI, ultrasound, and radiographic devices.
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Typical users of ZeTTA PACS include trained professionals such as physicians, radiologists, and medical technicians. Intended for use in hospitals and diagnostic centers.
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)
No clinical studies were considered necessary and performed.
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.
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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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.
1
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
2
(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
3
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 Description | 21 CFR Section | Product Code |
|---|---|---|
| Medical image management and processing system | 892.2050 | LLZ |
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.
6
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 Device | Predicate Device #1 | SE Decision | |
|---|---|---|---|
| K Number | - | K172803 | - |
| Manufacturer | TAE YOUNG SOFT CO., LTD | Infinitt Healthcare Co., Ltd. | - |
| Model | ZeTTA PACS | Infinitt PACS 7.0 | - |
| Indication for | |||
| Use | ZeTTA PACS is developed and designed for | ||
| the confirmation, storage, and maintenance of | |||
| medical images used for diagnosis within | |||
| hospitals. It is a DICOM viewer based on | |||
| Windows OS, enabling the storage, zooming, | |||
| viewing, and transmission of medical images, | |||
| as well as report generation. ZeTTA PACS | |||
| includes DICOM store, DICOM | |||
| query/retrieve, and DICOM print modules | |||
| that support the DICOM standard. It | |||
| simultaneously supports two high-resolution | |||
| monitors of FHD or higher and provides | |||
| Worklist functionality for efficient | |||
| diagnostics. | |||
| Typical users of this system are trained | |||
| professionals, e.g. physicians, radiologists, | |||
| nurses, and medical technicians. | Infinitt PACS 7.0 is a software device | ||
| that receives medical images and data | |||
| from various imaging sources. Image and | |||
| data can be stored, communicated, | |||
| processed, and displayed within the | |||
| system or across computer networks at | |||
| distributed locations. | |||
| Only preprocessed 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 meet technical specification identified | |||
| by FDA. Typical users of this system are | |||
| trained professionals. | Same | ||
| Imports scanned image of patient | Imports scanned image of patient | ||
| Module | Stand-alone software module | Stand-alone software module | Same |
| Support Built-in report module | Support Built-in report module | ||
| Proposed Device | Predicate Device #1 | SE Decision | |
| Managing patient | |||
| and case base data | Creating, editing, deleting and copying patient data | Creating, editing, deleting and copying patient data | Same |
| Worklist | Supports various worklist mode. | ||
| • Study list | |||
| • DICOM QR | |||
| • DICOM DIR | |||
| • Case | |||
| • Conference | |||
| • Technician worklist | |||
| • Viewed history | |||
| Supports short cut button for the specific folders of | |||
| each worklist mode (Quick | |||
| access) | Supports various worklist mode. | ||
| • Study list | |||
| • Favorite folder | |||
| • DICOM QR | |||
| • DICOM DIR | |||
| • Case | |||
| • Conference | |||
| • Technician worklist | |||
| • Embedded web | |||
| browser | |||
| • Viewed history | |||
| Supports short cut button for the specific | |||
| folders of each worklist mode (Quick | |||
| access) | Same | ||
| Support open the DICOM files directly (local open) | Support open the DICOM files directly (local | ||
| open) | |||
| Study list | • Searches the exams that meet the multiple search | ||
| conditions | |||
| • Exam list displays various information describing | |||
| the exams. | |||
| • Add, delete, change position and sort of each | |||
| information with header column control | |||
| • Supports create/edit/delete search folders that | |||
| contains the predefined search conditions | |||
| • Caches the images to the local disk with On-Call | |||
| function | |||
| • Exam list are configurable – font name, size, | |||
| color | |||
| • Launches the 3rd party application or web URL | |||
| with selected exam | |||
| information using External link | |||
| • Opens only key images in the selected exam | |||
| • Scans documents and attaches to the selected | |||
| exam | |||
| • Supports creating and view the comments of the | |||
| study for private-use or sharing with specified user | |||
| level. | |||
| • Assigns the priority of the study | |||
| • Creates and shows technician note | |||
| • Searches the historical exams of the selected | |||
| exam | |||
| • Creates and shows the report of the selected | |||
| exam | • Searches the exams that meet the multiple | ||
| search conditions | |||
| • Configurable fetching count for the exams. | |||
| • Exam list displays various information | |||
| describing the exams. | |||
| • Add, delete, change position and sort of each | |||
| information with header column control | |||
| • Supports refreshing the exam list | |||
| automatically by user configuration | |||
| • Exports the list of the selected exams to text | |||
| file or MS Excel compatible file(CSV) | |||
| • Supports create/edit/delete search folders | |||
| that 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 specific | |||
| terminology | |||
| • Launches the 3rd party application or web | |||
| URL with selected exam information using | |||
| External link | |||
| • Opens an exam or multiple exams in one | |||
| click | |||
| • Opens only key images in the selected exam | |||
| • Scans documents and attaches to the selected | |||
| exam | Same | ||
| Proposed Device | Predicate Device #1 | SE Decision | |
| • Supports creating and view the comments of | |||
| the study for private-use or sharing with | |||
| specified user level. | |||
| rule, Folder Lock) | |||
| • Assigns the priority of the study | |||
| • Assigns the referring doctor of the study | |||
| • Assigns the Radiologist (Read doctor) of the | |||
| study | |||
| • 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 the | |||
| series | Searches order and exam List | ||
| • Matches or un-matches the selected order | |||
| and exams | |||
| • Merges or un-merges the exam | |||
| • Splits the series from the exam to new one | |||
| • Modifies the information of the exam or the | |||
| series | Same | ||
| Embedded web | |||
| browser | Browses the web pages with predefined web URL | Browses the web pages with predefined web | |
| URL | |||
| Dashboard | Queries the number of exams that are met the | ||
| specified condition. | |||
| • Shows the study list that are met the specified | |||
| conditions | Queries the number of exams that are met the | ||
| specified condition. | |||
| • Shows the study list that are met the | |||
| specified conditions | |||
| General Viewing | • Displays the DICOM images which are stored in | ||
| PACS storage | |||
| • Accesses historical exams and report: Exam list | |||
| • Supports image arrangement and | |||
| manipulation using toolbar buttons, shortcut keys | |||
| or screen shortcut | |||
| • Support user-configurable mouse button action | |||
| • Configures the initial settings for each specific | |||
| modality | |||
| • Supports job saving | |||
| • Export or convert the displayed images as | |||
| DICOM or general image formats | • Displays the DICOM images which are | ||
| stored in PACS storage | |||
| • Accesses historical exams and report: | |||
| Timeline, Exam list | |||
| • Supports image arrangement and | |||
| manipulation using toolbar buttons, shortcut | |||
| keys or screen shortcut | |||
| • Support user-configurable mouse button | |||
| action | |||
| • Configures the initial settings for each | |||
| specific modality | |||
| • Supports job saving | |||
| • Export or convert the displayed images as | |||
| DICOM or general image formats | Same | ||
| 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) for | |||
| specific data | • Support display mode: | ||
| Stack / Image / Preset (VR/MPR/MIP / Web | |||
| URL /Report) | |||
| • Maximize and restore displayed image | |||
| • Support crosslink among the series in same | |||
| study | |||
| Proposed Device | Predicate Device #1 | SE 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/image | |||
| position | |||
| • Supports sequence display (Position/Time) | |||
| for specific data | |||
| Output | • Prints the images and report with paper or | ||
| DICOM printer | |||
| • Sends the images and report to DICOM station | |||
| • Various layout adjustment | |||
| • Report prints with output template which is | |||
| configurable for specific hospital | |||
| • Selects images for printing | |||
| • Prints images with or without patient | |||
| information, annotations and scale bar | • Prints the images and report with paper or | ||
| DICOM printer | |||
| • Sends the images and report to DICOM | |||
| station | |||
| • Export the images and report to MS | |||
| PowerPoint | |||
| • Various layout adjustment | |||
| • Report prints with output template which is | |||
| configurable for specific hospital | |||
| • Selects images for printing | |||
| • Prints images with or without patient | |||
| information, 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.
8
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
9
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.
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- 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.
- Performance Testing
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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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.