SaintView

• K Number: K223660
• Device Name: SaintView
• Manufacturer: Inviz Corporation
• Date Cleared: 2023-08-14 ( 251 days)
• Product Code: LLZ
• Regulation Number: 892.2050

Intended Use

SaintView is a software device that receives medical images and data from various 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

SaintView is a product for checking, analyzing, recording and storing images of medical images in hospitals. It has functions such as storing, transmitting, viewing, zooming in, reducing, moving and rotating medical images, as well as measuring length to aid in reading, and displaying various tools and reference positions. This product has a worklist for ease of reading, support for high-resolution medical monitors, and software division function for large monitors. In addition, it supports DICOM standard so that DICOM video can be checked in the viewer, and DICOM standard is also supported for video reception, transmission, CD creation, and printing.

Predicate Devices

K172803

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on standard PACS functionalities like image storage, viewing, manipulation, and measurement tools. There is no mention of AI, ML, or any advanced analytical capabilities beyond basic image processing and measurement. The performance study described is a measurement accuracy test, not an evaluation of an AI/ML algorithm's performance.

Therapeutic

No
The device is described as software for viewing, storing, and processing medical images. It aids in diagnosis by allowing trained professionals to interpret images but does not directly treat or prevent a disease or condition.

Diagnostic

Yes

The document states that 'Only preprocessed DICOM for presentation images can be interpreted for primary image diagnosis in mammography.' This explicitly indicates that the device is used for diagnostic purposes.

SaMD (Software as a Medical Device)

Yes

The device is explicitly described as a "software device" and its functions are entirely related to the handling, processing, and display of medical images and data. The performance studies mentioned are software validation and measurement accuracy tests, not hardware performance tests.

IVD (In Vitro Diagnostic)

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 treatment.
• This device, SaintView, is a software device that processes and displays medical images (like mammograms) and data. It works with images generated by imaging modalities, not with biological specimens.
• The intended use and device description clearly focus on image management, viewing, and basic measurement tools for interpreting medical images. There is no mention of analyzing biological samples or providing diagnostic information based on such analysis.

Therefore, SaintView falls under the category of medical image management and viewing software, not an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

SaintView is a software device that receives medical images and data from various imaging sources. Images and data can be stored, communicated, processed, and displayed within the system or across computer networks at distributed locations. Only preprocessed DICOM for presentation images can be interpreted for primary image diagnosis in mammography. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using a monitor that meets technical specification identified by FDA. Typical users of this system are trained professionals, e.g. physicians, radiologists, nurses, and medical technicians.

Product codes

LLZ

Device Description

SaintView is a product for checking, analyzing, recording and storing images of medical images in hospitals. It has functions such as storing, transmitting, viewing, zooming in, reducing, moving and rotating medical images, as well as measuring length to aid in reading, and displaying various tools and reference positions. This product has a worklist for ease of reading, support for high-resolution medical monitors, and software division function for large monitors. In addition, it supports DICOM standard so that DICOM video can be checked in the viewer, and DICOM standard is also supported for video reception, transmission, CD creation, and printing.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Typical users of this system are trained professionals, e.g. physicians, radiologists, nurses, and medical technicians.

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies

Measurement accuracy test for angles and distances. We conducted performance measurements using a standardized AAPM CT phantom which is commonly employed for evaluating imaging performance in clinical settings. The subject device met the evaluation criteria below which are outlined by the AAPM CT phantom guidelines.

Key Metrics

• Length Tapeline: Acceptable tolerance of error rate within +/- 0.03mm
• Angle: Quantitative measurements aligned with the actual values
• ROI: Acceptable tolerance of error rate within +/- 0.01 square inches
• Area: Acceptable tolerance of error rate within +/- 0.01 square centimeters
• Volume: Acceptable tolerance of error rate within +/- 0.15 mm3

Predicate Device(s)

K172803

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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).

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & 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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Inviz Corporation % Priscilla Chung Regulatory Affairs Consultant LK Consulting Group USA, Inc. 18881 Von Karman Ave., Suite 160 IRVINE CA 92612

August 14, 2023

Re: K223660

Trade/Device Name: SaintView Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: LLZ Dated: July 14, 2023 Received: July 14, 2023

Dear Priscilla Chung:

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

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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 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 (OS) 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Jessica Lamb

Jessica Lamb, Ph.D. Assistant Director Imaging Software Team DHT8B: Division of Radiological 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

510(k) Number (if known) K223660

Device Name SaintView

Indications for Use (Describe)

SaintView is a software device that receives medical images and data from various 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.

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

(K223660)

This summary of 510(k) is being submitted in accordance with requirements of 21 CFR Part 807.92.

Date: Aug 11, 2023

1. 510K Applicant / Submitter:

Inviz Corporation 307, Biomedical Components Center, Techno Park, 249, Chuam-ro, Buk-gu, Gwangju, Republic of Korea

2. Submission Contact Person

LK Consulting Group USA, Inc. 18881 Von Karman Ave STE 160, Irvine CA 92612 Priscilla Juhee Chung Phone: [phone] Fax: [phone] Email: [e-mail]

3. Device

• Proprietary Name: SaintView
• Common Name: Image Processing Software ●
• Classification: Class II (21 CFR 892.2050) .
• Product Code: LLZ .

4. Predicate Device

Infinitt PACS 7.0 (K172803) by Infinitt Healthcare Co., Ltd.

5. Description:

SaintView is a product for checking, analyzing, recording and storing images of medical images in hospitals. It has functions such as storing, transmitting, viewing, zooming in, reducing, moving and rotating medical images, as well as measuring length to aid in reading, and displaying various tools and reference positions. This product has a worklist for ease of reading, support for high-resolution medical monitors, and software division function for large monitors. In addition, it supports DICOM standard so that DICOM video can be checked in the viewer, and DICOM standard is also supported for video reception,

4

transmission, CD creation, and printing.

6. Indications for Use

SaintView 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.

7. Substantial Equivalence Discussion:

SaintView has the same intended use and the principle of operation, and also has similar features to the predicate devices, Infinitt PACS 7.0 (K172803).

There might be slight differences in features and menus, but these differences between the predicate device and the proposed device are not so significant since they do not raise any new or potential safety risks to the user or patient and questions of safety or effectiveness. Based on the results of software validation/verification tests and measurement accuracy test for angles and distances, we conclude that the proposed device is substantially equivalent to the predicate devices.

	Subject Device	Primary Predicate Device
Device Name	SaintView	Infinitt PACS 7.0
Manufacturer	Inviz Corporation	Infinitt Healthcare Co., Ltd.
Classification Name	System, Image Processing, Radiological	System, Image Processing, Radiological
Regulatory Number	21 CFR 892.2050	21 CFR 892.2050
Product Code	LLZ	LLZ
Classification	Class II	Class II
Review Panel	Radiology	Radiology
510K number	K223660	K172803
Indications for Use	SaintView 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.	Infinitt PACS 7.0TM, 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
	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.	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.
Operation System	Microsoft Windows 8/10	Microsoft Windows 7, 8.1, 10
32 bit / 64 bit	32 / 64 bit	32 / 64 bit
Image format	DICOM	DICOM
General Description	SaintView is a product for checking,
analyzing, recording diagnosis and storing
images of medical images generated for
diagnosis in hospitals. It has functions
such as storing, transmitting, viewing,
zooming in, reducing, moving and rotating
medical images, as well as measuring
length to aid in reading, and displaying
various tools and reference positions. This
product has a worklist for ease of reading,
support for high-resolution medical
monitors, and software division function
for large monitors. In addition, it supports
DICOM standard so that DICOM video
can be checked in the viewer, and DICOM
standard is also supported for video
reception, transmission, CD creation, and
printing.	Infinitt PACS 7.0TM 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 510(k) Summary of Safety
and Effectiveness Infinitt PACS 7.0TM 2
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.
DICOM	• DICOM JPEG compression
• DICOM JPEG2K compression(Only for Import)
• DICOM Multi-frame
• DICOM Storage (SCP)
• DICOM Storage (SCU)
• DICOM DIR - FSC, FSR, FSU
• DICOM Query/Retrieve (SCU)
• DICOM Multi-bytes character set
• DICOM Print	• DICOM JPEG compression
• DICOM JPEG2K compression
• DICOM Security (TLS)
• DICOM Multi-frame
• DICOM Storage (SCU)
• DICOM DIR - FSC, FSR, FSU
• DICOM Query/Retrieve (SCU)
• DICOM Grayscale Softcopy Presentation State (GSPS)
• DICOM Key Image Note
• DICOM Multi-bytes character set
• DICOM Print
Cybersecurity	• Access control and authentication
• Multiple access prohibited
• Do not hardcode passwords
• No password disclosure
• Ensuring the integrity of firmware or software updaters
• Integrity verification and response to major executable and configuration files
• Provides information on countermeasures to be taken when detecting cybersecurity threats	• Supports secured network protocol
• Supports auto log off
• Supports audit logging
• Restricting user behavior based on user roles and the institutional policies
Worklist
Worklist	General
• Supports various worklist mode
■ Study list
■ Favorite folder
■ DICOM QR
■ DICOM DIR
■ Case
■ Technician worklist
■ Viewed history
• Supports short cut button for the specific folders of each worklist mode (Quick access)
• Support open the DICOM files directly (local open)	General
• 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)
• Support open the DICOM files directly (local open)
	Study list
• 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	Study list
• 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
• Supports refreshing the exam list
automatically by user configuration
• Supports create/edit/delete search
folders that contains the predefined
search conditions
• Exam list are configurable – font
name, size, color
• Changes exam status using hospital
specific terminology
• 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
• Searches the historical exams of the
selected exam
• Creates and shows the report of the
selected exam	• 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
• 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	Favorite folder
• Creates, edits and deletes the folder
that are containing the interesting
exams.
• Adds interesting exam to specified
folder by mouse dragging from Study
list or creating snapshot for favorite
folder.
• Also, supports common functions for	• Creates, edits and deletes the folder
that are containing the interesting
exams.
• Supports sharing with another user
• Adds interesting exam to specified
folder by mouse dragging from Study
list or creating snapshot for favorite
folder.
exam in Study list
DICOM QR
• Supports the list of exams retrieved by	• Also, supports common functions for
exam in Study list
DICOM QR
• Supports the list of exams retrieved by
DICOM query from DICOM
compatible station.
• Supports send the selected exam to
other station.	DICOM query from DICOM
compatible station.
• Supports send the selected exam to
other station.
	DICOM DIR	DICOM DIR
	• Supports the list of exams in DICOM DIR
• Supports displaying the exam or sending it to other station.	• Supports the list of exams in DICOM DIR
• Supports displaying the exam or sending it to other station.
	Case
• Creates, edits and deletes the folder and case that are containing the interesting images	Case
• Creates, edits and deletes the folder and case that are containing the interesting images
• Supports sharing with another user
		Conference
• Creates, Modifies and Deletes the folder of specified conference and make a schedule of it
• Adds or deletes the exams for specified conference schedule
• Opens conference exam with or without snapshot
• Copies or moves the exams to next conference schedule
• Create and view the note (minutes) of the conference
	Technician worklist
• 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	Technician worklist
• 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
Embedded web browser
Browses the web pages with predefined web URL
	Dash Board
• Queries the number of exams that are met the specified condition
• Shows the study list that are met the specified conditions Notification	Dash Board
• Queries the number of exams that are met the specified condition
• Shows the study list that are met the specified conditions Notification
• Notices predefined schedules or events to PACS user.
Notification
• Notices predefined schedules or events to PACS user.
General Viewing	• 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
• 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
	Common tools Select Pan Zoom Windowing Magnification Fit Reset Print: Report / Film Hide demographic information Apply previous / next HP sequence Specific zoom: 100%, 1:1 Display (Monitor screen) Annotation Display DICOM information tool Monitor cine controller Save About Annotation / Measurement tools Image Display Etc tools Display DICOM information tool Monitor cine controller Save Call case folder External link About	Common tools Select Pan Zoom Windowing Magnification Fit Capture Reset Print: Report / Film 3D cursor Exam Refresh Dictation (play, record) Set as tape dictated Hide demographic information Save snapshot Apply previous / next HP sequence Specific zoom: 100%, 1:1 Display (Monitor screen) Annotation / Measurement tools Image Display 3D Tools Etc tools Display DICOM information tool Monitor cine controller Save Call case folder External link About Annotation / Measurement tools Image Display 3D Tools Etc tools Display DICOM information tool Monitor cine controller Save Call case folder External link About
Toolbar
Thumbnail		• Thumbnail display: series, image
• Displays series number and how many images are in specific series
• Displays an icon about the property of the series: Only one image in series, Multiple images in series, Multi-frame image in series

                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                       | • Thumbnail display: series, image

• Displays series number and how many images are in specific series
• Displays an icon about the property of the series: Only one image in series, Multiple images in series, Multi-frame image in series
• Supports opening the series or image by drag and drop the thumbnail or click it |
| Layout | | • Supports displaying multiple exams in a monitor by image set layout
• Supports displaying multiple series or images in the image set by cell layout | • Supports monitor merge
• Supports displaying multiple exams in a monitor by image set layout
• Supports displaying multiple series or images in the image set by cell layout |
| Visual Timeline | Displays the information of the patients that are opened Displays the list of all historical exams or relevant exams only for specific patient Displays the report text of the specific historical exam | Displays the information of the patients that are opened Displays the list of all historical exams or relevant exams only for specific patient Displays the report text of the specific historical exam Displays the series thumbnails of the specific historical exam Displays jobs and snapshots in this area when creating it. (Job container) | |
| Advanced Hanging
Protocol | Applies the user configurable hanging protocol for each type of exam when it is opened Support tools for managing user hanging protocols: Create / Copy / Export / Import / Copy from another user / Delete / Search Support user configuration for below settings in a hanging protocol Support multiple layout sequences in a hanging protocol (hanging protocol layout group) | Applies the user configurable hanging protocol for each type of exam when it is opened Support tools for managing user hanging protocols: Create / Copy / Export / Import / Copy from another user / Delete / Search Support user configuration for below settings in a hanging protocol Support multiple layout sequences in a hanging protocol (hanging protocol layout group) | |
| Image Display | | | |
| Common | Support split monitor display Support Hanging Protocol display Support Multi monitor display Maximize and restore displayed image Support easy compare mode. Support crosslink among the series in same study Support linked scrolling among the exams, even for difference exams Support linked scrolling by manual-selection Sets as key image | 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 Support linked scrolling among the exams, 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 | | | |
| Print | General Prints the images and report with paper or DICOM printer Sends the images and report to DICOM station Various layout adjustment Report print with output template which is configurable for specific hospital Selects images for printing Prints images with or without patient information, annotations and scale bar | General 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 print with output template which is configurable for specific hospital Selects images for printing Prints images with or without patient | |
| | | information, annotations and scale bar | |
| | General Supports Built-in report module Supports printing the text report with
template Dictation | General Supports Built-in report module Support displaying the information of
the reading exams Supports Reading workflow Supports temporally suspending the
report Supports merging the reports of
multiple unread exams of a patient Supports printing the text report with
template Dictation Dictation Stores the voice with MP3 voice file
format and updates the exam status for
it. Interface with Philips Speech Mike
controller Text Report Text Report Displays the reading history who and
when creates, updates and approves
the report Displays a report of historical exams
of the patient and copy the text from it Displays a predefined report template
and copy the text from it (Standard
report) Supports user-defined standard report Voice Recognition Interface with INFINITT Result
(Optional) Interface with 3rd Party VR system
(Optional) | |
| Report | Text Report Displays the reading history who and
when creates, updates and approves
the report Displays a report of historical exams
of the patient and copy the text from it Displays a predefined report template
and copy the text from it (Standard
report) Supports user-defined standard report | | |

5

6

7

8

9

10

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8. Performance Tests

• Measurement accuracy test for angles and distances.
  We conducted performance measurements using a standardized AAPM CT phantom which is commonly employed for evaluating imaging performance in clinical settings. The subject device met the evaluation criteria below which are outlined by the AAPM CT phantom guidelines.

| Category | acceptable tolerance of error rate within the measurement
range for passing |
|--------------------|--------------------------------------------------------------------------------|
| Length
Tapeline | Acceptable tolerance of error rate within $\pm$ 0.03mm |
| Angle | Quantitative measurements aligned with the actual values |
| ROI | Acceptable tolerance of error rate within $\pm$ 0.01 square inches |

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| Area | Acceptable tolerance of error rate within ±0.01 square
centimeters |
|--------|-----------------------------------------------------------------------|
| Volume | Acceptable tolerance of error rate within ±0.15 mm3 |

• SW Validation

9. Conclusions:

Based on the testing performed and the information provided herein, we conclude that the subject device is substantially equivalent to the predicate device.