Infinitt PACS 7.0

K172803 · Infinitt Healthcare Co., Ltd. · LLZ · Oct 27, 2017 · Radiology

Device Facts

• Record ID: K172803
• Device Name: Infinitt PACS 7.0
• Applicant: Infinitt Healthcare Co., Ltd.
• Product Code: LLZ · Radiology
• Decision Date: Oct 27, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

Infinitt PACS 7.0, 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 Story

Infinitt PACS 7.0 is a web-based, 3D-enabled DICOM view station; operates on Windows 7/8.1/10. Inputs include medical images/data from various imaging modalities via DICOM 3.x. System stores, communicates, processes, and displays images across networks. Features include advanced viewing, hanging protocols, 3D display (MPR, Volume Rendering, MIP, fusion), and web-based remote access. Used in clinical environments by radiologists, physicians, nurses, and technicians. Software does not contact patients, control life-sustaining equipment, or provide diagnostic assistance; physician retains full responsibility for interpretation and clinical decision-making. Benefits include remote access to diagnostic environments and efficient network transfer via JPEG 2000.

Clinical Evidence

Bench testing only. System configuration tested at factory against pre-determined functional requirements in Software Requirements Specification and User Manual. No clinical data provided; device does not provide diagnostic assistance.

Technological Characteristics

Software-based PACS; runs on Windows 7/8.1/10. Supports DICOM 3.x standards (JPEG/JPEG2K compression, TLS security, GSPS, Multi-frame). Features 3D rendering (MPR, MIP, Volume Rendering). Networked deployment; web-based. Cybersecurity includes secured network protocols, auto log-off, audit logging, and role-based access control.

Indications for Use

Indicated for trained professionals (physicians, radiologists, nurses, medical technicians) to receive, store, communicate, process, and display medical images/data from various sources. Mammography primary diagnosis requires preprocessed DICOM for presentation images; lossy compressed or digitized film-screen images are contraindicated for primary interpretation.

Regulatory Classification

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.

Special Controls

*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).

Predicate Devices

• INFINITT G3 PACS (K052545)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

October 27, 2017

Infinitt Healthcare Co., Ltd. C/O Carl Alletto Regulatory Consultant 8317 Belew Dr. McKinney TX 75071

Re: K172803

Trade/Device Name: Infinitt PACS 7.0 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: September 9, 2017 Received: September 26, 2017

Dear Mr. Alletto:

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. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21. Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely.

Robert Oals

Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known)

K172803

Device Name Boviot PACS 7.0"

Indications for Use (Describe)

Infinitt PACS 7.0,"is a software device that receives medical images and data from various imaging sources. Images and data can be stored, communicated, 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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This 510(k) Summary of Safety and Effectiveness information is being submitted in accordance with the requirements of SMDA 1990.

Date Prepared:

September 8, 2017

Submitter's Information: 21 CFR 807.92(a)(1) Mr. Sanq Wook Cho Chief Quality Officer, Research and Development Center, INFINITT Healthcare Co., Ltd 12FI Daerung Post Tower III, 27 Digital-ro 34-gil, Guro-gu, Seoul 08378, South Korea Tel [phone] Fax [phone] Email: [e-mail]

Trade Name, Common Name and Classification: 21 CFR 807.92(a)(2)

| Trade Name: | Infinitt PACS 7.0™ |
|------------------------|-----------------------------------------|
| Common Name: | Picture Archiving Communications System |
| Device Classification: | 892.2050 System, Image Processing |
| Product Code: | LLZ |

### Predicate Device: 21 CFR 807. 92(a)(3)

| Device Classification Name | system, image processing, radiological22 |
|------------------------------|------------------------------------------|
| 510(k) Number | K052545 |
| Device Name | INFINITT G3 PACS |
| Applicant | INFINITT CO., LTD. |
| Regulation Number | 892.205023 |
| Classification Product Code | LLZ24 |
| Date Received | 09/15/2005 |
| Decision Date | 11/08/2005 |
| Decision | substantially equivalent (SESE) |
| Regulation Medical Specialty | Radiology |
| 510k Review Panel | Radiology |
| summary | summary25 |
| Type | Traditional |
| Reviewed by Third Party | No |
| Combination Product | No |

#### Device Description: 21 CFR 807 92(a)(4)

Infinitt PACS 7.0™ device is PACS software capable of viewing and handling DICOM 3.x medical images. The System allows displaying of images and image studies that may not in the location as the modality. With its Web features, it is possible to review, modify, and approve studies located in a remote server.

INFINITT PACS is a software device that does not contact the patient, nor does it control any life sustaining devices. The software does not provide any diagnostic assistance to the physician. Any diagnostic determination or treatment is solely determined by a

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physician and not the software. A physician, providing ample opportunity for competent human intervention, interprets images and information being displayed and printed.

Infinitt PACS 7.0 is a web-based, 3D-enabled DICOM view station running on Windows 7/8.1/10. Infinitt PACS 7.0 is an integral component of INFINITT's complete INFINITT PACS/RIS solution. Infinitt PACS 7.0 fully supports DICOM standards and such functions as advanced DICOM viewing, Hanging Protocol, various 3D display such as MPR, Volume Rendering, MIP and fusion. Infinitt PACS 7.0 allows users to take full advantage of the radiographic images from various modalities in order to obtain invaluable mission critical diagnostic data and images.

With Infinitt PACS 7.0, users can access their own diagnostic environment anywhere, anytime. This is made possible because Infinitt PACS 7.0 is deployed through a network and supports hanging protocol. Also, Infinitt PACS 7.0 uses JPEG 2000 features so that it takes less time to transfer images through a network.

Infinitt PACS 7.0 is based upon the INFINITT G3 PACS (predicate device). The features and functions of Infinitt PACS 7.0 have similar features and functions of G3 PACS with an updated operating system due to current advances in computer technology.

#### Indications for Use: 21 CFR 807 92(a)(5)

Infinitt PACS 7.0™, 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: 21 CFR 807 92(a)(6)

Infinitt PACS 7.0™ device is a software product that acquires, handles, displays and manages 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. The general features and functions of the device are:

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| Category | Subject Device: INFINITT<br>PACS 7.0 | Predicate device: INFINITT<br>G3 (K052545) | Explain why<br>differences do not<br>affect patient safety<br>or effectiveness. |
|---------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Overview | | | |
| General | ●<br>Same as predicate except<br>for the operating system.<br>■ Runs on Microsoft<br>Windows 7 / 8.1 / 10 | ●<br>Runs on Microsoft<br>Windows XP / Vista / 7 /<br>8.1<br>●<br>Supports a combination<br>of various types of<br>monitors including VGA<br>and high-resolution<br>monitors<br>●<br>Integration-less<br>synchronization of PACS<br>and 3D functions<br>●<br>Automatically detects<br>monitor resolution and<br>magnification<br>●<br>Intuitively applies setting<br>values<br>●<br>Links internal viewer to<br>external HIS/RIS report<br>system<br>●<br>Supports launching<br>external programs with<br>various parameter from<br>specified exam<br>information<br>●<br>Supports Direct CD/USB<br>Burning and Media<br>server backup<br>●<br>Supports Anonymize<br>Direct CD/USB Burning<br>and Media server<br>●<br>Stores all user settings in<br>the database (Roaming<br>user profile) | Differences: Subject<br>Device does not run on<br>Microsoft XP or Vista.<br>The differences<br>between the subject<br>device and the<br>predicate device is due<br>to the advancement in<br>computer OS<br>technology since the<br>time predicate device<br>was cleared by FDA.<br>Microsoft XP or Vista<br>are no longer supported<br>by Microsoft.<br>The differences<br>indicated, do not raise<br>any new potential<br>safety risks and<br>therefore, there is no<br>impact on safety or<br>efficacy for the subject<br>device. |
| Deploy | ● Web-based deployment<br>● Smart upgrade | ● Web-based deployment<br>● Smart upgrade | No differences |
| Compatibility<br>- DICOM<br>functions | ● DICOM JPEG compression<br>● DICOM JPEG2K<br>compression<br>● DICOM Security (TLS)<br>● DICOM Multi-frame<br>● DICOM Storage (SCU)<br>● DICOM DIR - FSC, FSR,<br>FSU<br>● DICOM Query/Retrieve<br>(SCU)<br>● DICOM Grayscale Softcopy<br>Presentation State (GSPS) | ● DICOM JPEG<br>compression<br>● DICOM JPEG2K<br>compression<br>● DICOM Security (TLS)<br>● DICOM Multi-frame<br>● DICOM Storage (SCU)<br>● DICOM DIR - FSC, FSR,<br>FSU<br>● DICOM Query/Retrieve<br>(SCU)<br>● DICOM Grayscale | No differences |
| | | | |
| | ● DICOM Key Image Note | Softcopy Presentation<br>State (GSPS) | |
| | ● DICOM Multi-bytes<br>character set | ● DICOM Key Image Note | |
| | ● DICOM Print | ● DICOM Multi-bytes<br>character set | |
| Cyber<br>security | ● Supports secured network<br>protocol | ● DICOM Print<br>● Supports secured<br>network protocol | No differences |
| | ● Supports auto log off | ● Supports auto log off | |
| | ● Supports audit logging | ● Supports audit logging | |
| | ● Restricting user behavior<br>based on user roles and<br>the institutional policies | ● Restricting user behavior<br>based on user roles and<br>the institutional policies | |
| Worklist | | | |
| Worklist | General | General | Yes, there are<br>differences. There is |
| | ● Supports various worklist<br>mode | ● Supports various worklist<br>mode | additional functionality<br>in the subject device. |
| | ■ Study list | ■ Study list | The added features and |
| | ■ Favorite folder | ■ Favorite folder | functions of the subject<br>device is described in |
| | ■ DICOM QR | ■ DICOM QR | labeling, so the User |
| | ■ DICOM DIR | ■ DICOM DIR | will be aware of the |
| | ■ Case | ■ Case | system functionality.<br>The additional items do |
| | ■ Conference | ● Support open the DICOM<br>files directly (local open) | not change the |
| | ■ Technician worklist | Study list | Inductions for Use as |
| | ■ Embedded web<br>browser | ● Searches the exams that<br>meet the multiple search<br>conditions | compared to the |
| | ■ Viewed history | ● Configurable fetching<br>count for the exams. | predicate. The<br>differences do not raise |
| | ● Supports short cut button<br>for the specific folders of<br>each worklist mode (Quick<br>access) | ● Exam list displays<br>various information<br>describing the exams. | any new potential<br>safety risks and |
| | ● Support open the DICOM<br>files directly (local open) | ● Add, delete, change<br>position and sort of each<br>information with header<br>column control | therefore, we believe<br>there is no impact on |
| | Study list | ● Supports refreshing the<br>exam list automatically<br>by user configuration | safety or efficacy for the<br>subject device. |
| | ● Searches the exams that<br>meet the multiple search<br>conditions | ● Exports the list of the<br>selected exams to text<br>file or MS Excel<br>compatible file (CSV) | |
| | ● Configurable fetching count<br>for the exams. | ● Supports<br>create/edit/delete search<br>folders that contains the<br>predefined search<br>conditions | |
| | ● Exam list displays various<br>information describing the<br>exams. | | |
| | ● Add, delete, change<br>position and sort of each<br>information with header<br>column control | | |
| | ● Supports refreshing the<br>exam list automatically by<br>user configuration | | |

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| 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 Limit data access (Passcode Rule, Hiding rule, Folder Lock) Supports creating and view the comments of the study for private-use or sharing with specified user level. 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 | 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 Limit data access (Passcode Rule, Hiding rule, Folder Lock) Supports creating and view the comments of the study for private-use or sharing with specified user level. 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 Favorite folder Creates, edits and deletes the folder that are containing the |
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| | Creates, edits and deletes | | inte |
|------|----------------------------------------------------------------------|-------|--------------|
| | the folder that are | | Add |
| | containing the interesting | | spe |
| | exams. | | mou |
| | Supports sharing with | | Stud |
| | another user | | Alsc<br>func |
| | Adds interesting exam to<br>specified folder by mouse | | Stud |
| | dragging from Study list or | DICOM | |
| | creating snapshot for<br>favorite folder. | | Sup<br>exa |
| | Also, supports common | | DIC |
| | functions for exam in Study<br>list | | DIC<br>stat |
| | DICOM QR | | Sup |
| ● | Supports the list of exams | | sele |
| | retrieved by DICOM query | | stat |
| | from DICOM compatible<br>station. | DICOM | Sup |
| | Supports send the selected<br>exam to other station. | | exa<br>Sup |
| | DICOM DIR | | exa |
| | Supports the list of exams<br>in DICOM DIR | Case | othe |
| | Supports displaying the<br>exam or sending it to other | œ | Cre<br>dele |
| | station. | | cas |
| Case | | | the |
| | Creates, edits and deletes | | Sup<br>ano |
| | the folder and case that are<br>containing the interesting<br>images | | |
| | Supports sharing with<br>another user | | |
| | Conference | | |
| | Creates, Modifies and | | |
| | Deletes the folder of | | |
| | specified conference and<br>make a schedule of it | | |
| | Adds or deletes the exams<br>for specified conference | | |
| | schedule | | |
| | Opens conference exam | | |
| | with or without snapshot | | |
| | Copies or moves the | | |
| | exams to next conference<br>schedule | | |
| | Create and view the note<br>(minutes) of the conference | | |
| | Technician worklist | | |

- ls interesting exam to cified folder by use dragging from dy list.
- o, supports common ctions for exam in dy list

### QR

- ports the list of ms retrieved by OM query from COM compatible ion.
- ports send the ected exam to other ion.

### DIR

- ports the list of ms in DICOM DIR
- ports displaying the m or sending it to er station.
- ates, edits and etes the folder and e that are containing interesting images
- ports sharing with ther user

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| General<br>Viewing | 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 <b>Embedded web browser</b> Browses the web pages with predefined web URL <b>Dash Board</b> Queries the number of exams that are met the specified condition Shows the study list that are met the specified conditions <b>Notification</b> Notices predefined schedules or events to PACS user. | | 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 | 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 or shortcut keys 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 | Yes, there are differences. There is additional functionality in the subject device. The added features and functions of the subject device is described in labeling, so the User will be aware of the system functionality. The additional items do not change the Inductions for Use as compared to the predicate. The differences do not raise any new potential safety risks and therefore, we believe there is no impact on safety or efficacy for the subject device. |
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