(39 days)
Not Found
No
The document explicitly states that the software does not provide any diagnostic assistance and that diagnostic determination is solely determined by a physician. There is no mention of AI or ML in the description of the device's functionality.
No.
The device is described as software for viewing and handling medical images, not for providing therapy or affecting the patient directly.
No
The input states: "The software does not provide any diagnostic assistance to the physician. Any diagnostic determination or treatment is solely determined by a physician and not the software."
Yes
The device description explicitly states "INFINITT PACS is a software device" and details its functions related to viewing, handling, and displaying medical images and data, without mentioning any accompanying hardware components included in the device submission.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Infinitt PACS 7.0 is a software device that handles, stores, communicates, and displays medical images (like X-rays, CT scans, etc.) and associated data. It facilitates the viewing and interpretation of these images by trained professionals.
- Lack of Biological Sample Analysis: The description explicitly states that the device receives "medical images and data" and "DICOM 3.x medical images." There is no mention of analyzing biological samples from the patient.
- Focus on Image Interpretation: The primary function described is the display and manipulation of images for diagnostic interpretation by a physician.
Therefore, the Infinitt PACS 7.0 falls under the category of medical imaging software or a Picture Archiving and Communication System (PACS), not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for 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, 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 (comma separated list FDA assigned to the subject device)
LLZ
Device Description
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 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.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The complete system configuration has been tested at the factory and the device has passed all in-house pre-determined testing criteria without significant failures. The data presented in the submission demonstrates that Infinitt PACS 7.0™ performs as required according to the functional requirements specified in the Software Requirements Specification and the User Manual with no errors that had an impact on safety or efficacy.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized representation of three human profiles facing right, stacked on top of each other. The profiles are rendered in black and have a flowing, abstract design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the profiles.
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.
1
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 (800) 638 2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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
2
Indications for Use
510(k) Number (if known)
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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3
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 +82-2-2192-1631 Fax +82-2-3663-8426 Email: bigmouse@infinitt.com
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
4
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:
5
| Category | Subject Device: INFINITT
PACS 7.0 | Predicate device: INFINITT
G3 (K052545) | Explain why
differences do not
affect patient safety
or effectiveness. |
|---------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Overview | | | |
| General | ●
Same as predicate except
for the operating system.
■ Runs on Microsoft
Windows 7 / 8.1 / 10 | ●
Runs on Microsoft
Windows XP / Vista / 7 /
8.1
●
Supports a combination
of various types of
monitors including VGA
and high-resolution
monitors
●
Integration-less
synchronization of PACS
and 3D functions
●
Automatically detects
monitor resolution and
magnification
●
Intuitively applies setting
values
●
Links internal viewer to
external HIS/RIS report
system
●
Supports launching
external programs with
various parameter from
specified exam
information
●
Supports Direct CD/USB
Burning and Media
server backup
●
Supports Anonymize
Direct CD/USB Burning
and Media server
●
Stores all user settings in
the database (Roaming
user profile) | Differences: Subject
Device does not run on
Microsoft XP or Vista.
The differences
between the subject
device and the
predicate device is due
to the advancement in
computer OS
technology since the
time predicate device
was cleared by FDA.
Microsoft XP or Vista
are no longer supported
by Microsoft.
The differences
indicated, do not raise
any new potential
safety risks and
therefore, there is no
impact on safety or
efficacy for the subject
device. |
| Deploy | ● Web-based deployment
● Smart upgrade | ● Web-based deployment
● Smart upgrade | No differences |
| Compatibility
- DICOM
functions | ● 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 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 | No differences |
| | | | |
| | ● DICOM Key Image Note | Softcopy Presentation
State (GSPS) | |
| | ● DICOM Multi-bytes
character set | ● DICOM Key Image Note | |
| | ● DICOM Print | ● DICOM Multi-bytes
character set | |
| Cyber
security | ● Supports secured network
protocol | ● DICOM Print
● Supports secured
network protocol | No differences |
| | ● Supports auto log off | ● Supports auto log off | |
| | ● Supports audit logging | ● Supports audit logging | |
| | ● Restricting user behavior
based on user roles and
the institutional policies | ● Restricting user behavior
based on user roles and
the institutional policies | |
| Worklist | | | |
| Worklist | General | General | Yes, there are
differences. There is |
| | ● Supports various worklist
mode | ● Supports various worklist
mode | additional functionality
in the subject device. |
| | ■ Study list | ■ Study list | The added features and |
| | ■ Favorite folder | ■ Favorite folder | functions of the subject
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.
The additional items do |
| | ■ Conference | ● Support open the DICOM
files directly (local open) | not change the |
| | ■ Technician worklist | Study list | Inductions for Use as |
| | ■ Embedded web
browser | ● Searches the exams that
meet the multiple search
conditions | compared to the |
| | ■ Viewed history | ● Configurable fetching
count for the exams. | predicate. The
differences do not raise |
| | ● Supports short cut button
for the specific folders of
each worklist mode (Quick
access) | ● Exam list displays
various information
describing the exams. | any new potential
safety risks and |
| | ● Support open the DICOM
files directly (local open) | ● Add, delete, change
position and sort of each
information with header
column control | therefore, we believe
there is no impact on |
| | Study list | ● Supports refreshing the
exam list automatically
by user configuration | safety or efficacy for the
subject device. |
| | ● Searches the exams that
meet the multiple search
conditions | ● Exports the list of the
selected exams to text
file or MS Excel
compatible file (CSV) | |
| | ● Configurable fetching count
for the exams. | ● Supports
create/edit/delete search
folders that contains the
predefined search
conditions | |
| | ● 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 | | |
6
7
| 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 |
|---|---|
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
8
| Creates, edits and deletes | inte | ||
|---|---|---|---|
| the folder that are | Add | ||
| containing the interesting | spe | ||
| exams. | mou | ||
| Supports sharing with | Stud | ||
| another user | Alsc | ||
| func | |||
| Adds interesting exam to | |||
| specified folder by mouse | Stud | ||
| dragging from Study list or | DICOM | ||
| creating snapshot for | |||
| favorite folder. | Sup | ||
| exa | |||
| Also, supports common | DIC | ||
| functions for exam in Study | |||
| list | DIC | ||
| stat | |||
| DICOM QR | Sup | ||
| ● | Supports the list of exams | sele | |
| retrieved by DICOM query | stat | ||
| from DICOM compatible | |||
| station. | DICOM | Sup | |
| Supports send the selected | |||
| exam to other station. | exa | ||
| Sup | |||
| DICOM DIR | exa | ||
| Supports the list of exams | |||
| in DICOM DIR | Case | othe | |
| Supports displaying the | |||
| exam or sending it to other | œ | Cre | |
| dele | |||
| station. | cas | ||
| Case | the | ||
| Creates, edits and deletes | Sup | ||
| ano | |||
| 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 |
- 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
9
| General
| 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 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 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. | |
|---|---|---|---|---|---|
| Toolbar | Common tools Select Pan | Common tools Select Pan | Yes, there is an added "Findings List" feature in the subject device. |
10
| ZoomWindowingMagnificationFitCaptureResetPrint: Report / Film3D cursorExam RefreshDictation (play, record)Set as tape dictatedHide demographic informationSave snapshotApply previous / next HP sequenceSpecific zoom: 100%, 1:1 Display (Monitor screen)Annotation / Measurement toolsImage Display3D ToolsEtc toolsDisplay DICOM information toolMonitor cine controllerSaveCall case folderExternal linkAbout | ZoomWindowingMagnificationFitCaptureResetPrint: Report / Film3D cursorExam RefreshDictation (play, record)Set as tape dictatedHide demographic informationSave snapshotApply previous / next HP sequenceSpecific zoom: 100%, 1:1 Display (Monitor screen)Annotation / Measurement toolsImage Display3D ToolsEtc toolsDisplay DICOM information toolMonitor cine controllerSaveCall case folderExternal linkAbout | The added feature is described in labeling, so the User will be aware of the system functionality. The additional item does not change the Inductions for Use as compared to the predicate. The difference does not raise any new potential safety risks and therefore, we believe there is no impact on safety or efficacy for the subject device. | |
|---|---|---|---|
| Thumbnail | Thumbnail display: series, imageDisplays series number and how many images are in specific seriesDisplays an icon about the property of the series: Only one image in series, Multiple images in series, Multi-frame image in seriesSupports opening the series or image by drag and drop the thumbnail or click it | Thumbnail display: series, imageDisplays series number and how many images are in specific seriesSupports opening the series or image by drag and drop the thumbnail or click it | Yes, there is a difference in that the subject device displays an icon about the property of the series: Only one image in series, Multiple images in series, Multi-frame image in series. The added feature is described in labeling, so the User will be aware of the system functionality. The additional item does not change the Inductions for Use as compared to the predicate. The difference does not |
| 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 | 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 | No differences |
| 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 series thumbnails of the specific historical exam Displays jobs and snapshots in this area when creating it. (Job container) | (N/A) | Yes, differences. This is a new feature that is not in the predicate 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. |
| 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 | Yes, there is a difference between the subject and predicate devices. The subject support multiple layout sequences in a hanging protocol (hanging protocol layout group). This is a new feature that is not in the predicate device. The added features and functions of the subject device is described in labeling, so the User will be aware of the system functionality. |
| Image | |||
| Display | 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. | |||
| Common | 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 | Support display mode: | ||
| Series / Image / Preset | |||
| (VR / MPR / MIP / Endo / | |||
| FMX) 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 series 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 | No differences | ||
| Advanced | |||
| Display | |||
| Fusion | Adjustable blending rate Separated windowing for | ||
| each fusion data Screen capture for further | |||
| use | Manually adjusted | ||
| registration Adjustable blending rate | |||
| in MIP/MPR fusion Separated windowing for | |||
| each fusion data | No differences | ||
| Mammo | |||
| Display | Mammo CAD interface: R2 Mammo CAD interface : i- | ||
| CAD SR Mammo Hanging Protocol | |||
| Loop Sequence | Mammo CAD interface: | ||
| R2 Mammo CAD interface : | |||
| i-CAD SR Mammo Loop Sequence | No differences | ||
| Magnification, Pan, B/W | |||
| Invert | Magnification, Pan, B/W | ||
| Invert | |||
| Quadrant Zoom | Quadrant Zoom | ||
| Clear Filter | Clear Filter | ||
| Custom View Layout | Custom View Layout | ||
| Auto breast fit display | Auto breast fit display | ||
| Breast Tomosynthesis view mode | Breast Tomosynthesis | ||
| view mode | |||
| Controlled with INFINITT Mammo Keypad (option) | Controlled with INFINITT | ||
| Mammo Keypad (option) | |||
| 3D Display | |||
| Image display - | |||
| Common | Volume Rendering | Volume Rendering | No differences |
| OTF windowing: See below in more detail | OTF windowing: See | ||
| below in more detail | |||
| Interactive 3D rendering reflecting the change of OTF | Interactive 3D rendering | ||
| reflecting the change of | |||
| OTF | |||
| VOI display (slab rendering): See below in more detail | VOI display (slab | ||
| rendering): See below in | |||
| more detail | |||
| Batch rendering | Batch rendering | ||
| Orientation cube display | Orientation cube display | ||
| Orientation preset | Orientation preset | ||
| Bounding box display | Bounding box display | ||
| Synchronize VR with MIP | Synchronize VR with MIP | ||
| MPR | MPR | ||
| Supports classic reformation planes: Axial, Sagittal, Coronal and Oblique plane | Supports classic reformation planes: Axial, | ||
| Sagittal, Coronal and | |||
| Oblique plane | |||
| Supports image scroll using mouse drag on images | Supports image scroll | ||
| using mouse drag on | |||
| images | |||
| Various crosshair shape: | |||
| Show/Hide, Hollow, Small size | Various crosshair shape: | ||
| Show/Hide, Hollow, | |||
| Small size | |||
| Double oblique MPR | Double oblique MPR | ||
| Curved MPR | Curved MPR | ||
| Rotate reformation plane | Rotate reformation plane | ||
| Batch MPR with cine support | Batch MPR with cine | ||
| support | |||
| Slab MPR: Raysum, MIP, MinIP | Slab MPR: Raysum, | ||
| MIP, MinIP | |||
| Output | |||
| General | General | No Differences | |
| Prints the images and report with paper or DICOM printer | Prints the images and | ||
| report with paper or | |||
| DICOM printer | |||
| Sends the images and | 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 | 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 | |||
| Report | 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 Stores the voice with MP3 | |||
| voice file format and | |||
| updates the exam status for | |||
| it. Interface with Philips | |||
| Speech Mike controller 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 | 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 Stores the voice with | |||
| MP3 voice file format and | |||
| updates the exam status | |||
| for it. Interface with Philips | |||
| Speech Mike controller 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) | No Differences |
11
12
13
14
15
| Voice Recognition Interface with INFINITT Result (Optional) Interface with 3rd Party VR system (Optional) | Supports user-defined standard report Voice Recognition Interface with INFINITT Result (Optional) Interface with 3rd Party VR system (Optional) |
|---|---|
| ------------------------------------------------------------------------------------------------------------------ | -------------------------------------------------------------------------------------------------------------------------------------------------------- |
Testing
The complete system configuration has been tested at the factory and the device has passed all in-house pre-determined testing criteria without significant failures. The data presented in the submission demonstrates that Infinitt PACS 7.0™ performs as required according to the functional requirements specified in the Software Requirements Specification and the User Manual with no errors that had an impact on safety or efficacy.
Conclusion: 21 CFR 807 92(b)(1)
The 510 (k) Pre-Market Notification for Infinitt PACS 7.0™ contains adequate information and data to enable FDA - CDRH to determine substantial equivalence to the predicate device. Infinitt PACS 7.0™ has been and will be manufactured in accordance with the voluntary standards listed in the enclosed voluntary standard survey. The submission contains the results of a hazard analysis and the "Level of Concern for potential hazards has been classified as "Moderate".