(251 days)
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.
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.
The provided text describes the Inviz Corporation's SaintView device, a medical image management and processing system, and its performance tests.
Here's an analysis of the acceptance criteria and study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
| Category | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Length / Tapeline | Acceptable tolerance of error rate within $\pm$ 0.03mm | Met the evaluation criteria (within $\pm$ 0.03mm) |
| Angle | Quantitative measurements aligned with the actual values | Met the evaluation criteria (aligned with actual values) |
| ROI | Acceptable tolerance of error rate within $\pm$ 0.01 square inches | Met the evaluation criteria (within $\pm$ 0.01 square inches) |
| Area | Acceptable tolerance of error rate within $\pm$ 0.01 square centimeters | Met the evaluation criteria (within $\pm$ 0.01 square centimeters) |
| Volume | Acceptable tolerance of error rate within $\pm$ 0.15 mm$^3$ | Met the evaluation criteria (within $\pm$ 0.15 mm$^3$) |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document mentions using a "standardized AAPM CT phantom" for performance measurements. It does not specify a sample size in terms of number of cases or images, nor does it provide information about data provenance (e.g., country of origin, retrospective/prospective). The use of a phantom suggests controlled, synthetic data rather than real patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided in the document. The performance tests rely on measurements against a standardized phantom, which inherently has known ground truth values for length, angle, ROI, area, and volume. Therefore, human expert review for establishing ground truth on a test set (in the typical sense for diagnostic AI) would not be directly applicable for these specific measurement accuracy tests.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Adjudication methods are not applicable for the reported performance tests. The ground truth for the measurement accuracy tests is derived from the known dimensions of the standardized AAPM CT phantom, not from expert consensus.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
There is no mention of a multi-reader multi-case (MRMC) comparative effectiveness study. The tests described focus solely on the device's measurement accuracy on a phantom, not on its impact on human reader performance or diagnostic effectiveness with human-in-the-loop.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The presented performance tests on the AAPM CT phantom are effectively standalone performance tests for the device's measurement capabilities, as they assess the algorithm's ability to accurately measure predefined features without human intervention in the measurement process itself.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The ground truth for the "Measurement accuracy test for angles and distances" was established by the known, actual values of a standardized AAPM CT phantom. This represents a form of objective, physical ground truth.
8. The sample size for the training set
The document does not provide any information about a training set or its sample size. This type of device is an image processing and management system, not a diagnostic AI algorithm that is typically trained on large datasets. The verification appears to focus on the accuracy of its implemented measurement tools.
9. How the ground truth for the training set was established
Since no training set information is provided, this is not applicable/available from the document.
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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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: 714.202.5789 Fax: 714-409-3357 Email: juhee.c@lkconsultinggroup.com
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,
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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 thatreceives medical images and data fromvarious imaging sources. Images and datacan be stored, communicated, processed,and displayed within the system or acrosscomputer networks at distributedlocations. Only preprocessed DICOM forpresentation images can be interpreted forprimary image diagnosis inmammography. Lossy compressedmammographic images and digitized filmscreen images must not be reviewed forprimary image interpretations. | Infinitt PACS 7.0TM, is a software devicethat receives medical images and data fromvarious imaging sources. Images and datacan be stored, communicated, processed,and displayed within the system or acrosscomputer networks at distributed locations.Only preprocessed DICOM for presentationimages can be interpreted for primaryimage diagnosis in mammography. Lossycompressed mammographic images anddigitized film screen images must not bereviewed for primary image interpretations.Mammographic images may only be | |
| Mammographic images may only beinterpreted using a monitor that meetstechnical specification identified by FDA.Typical users of this system are trainedprofessionals, e.g. physicians, radiologists,nurses, and medical technicians. | interpreted using a monitor that meetstechnical specification identified by FDA.Typical users of this system are trainedprofessionals, 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 storingimages of medical images generated fordiagnosis in hospitals. It has functionssuch as storing, transmitting, viewing,zooming in, reducing, moving and rotatingmedical images, as well as measuringlength to aid in reading, and displayingvarious tools and reference positions. Thisproduct has a worklist for ease of reading,support for high-resolution medicalmonitors, and software division functionfor large monitors. In addition, it supportsDICOM standard so that DICOM videocan be checked in the viewer, and DICOMstandard is also supported for videoreception, transmission, CD creation, andprinting. | Infinitt PACS 7.0TM device is PACSsoftware capable of viewing and handlingDICOM 3.x medical images. The Systemallows displaying of images and imagestudies that may not in the location as themodality. With its Web features, it ispossible to review, modify, and approvestudies located in a remote server.INFINITT PACS is a software device thatdoes not contact the patient, nor does itcontrol any life sustaining devices. Thesoftware does not provide any diagnosticassistance to the physician. Any diagnosticdetermination or treatment is solelydetermined by a 510(k) Summary of Safetyand Effectiveness Infinitt PACS 7.0TM 2physician and not the software. Aphysician, providing ample opportunity forcompetent human intervention, interpretsimages and information being displayedand printed.Infinitt PACS 7.0 is a web-based, 3D-enabled DICOM view station running onWindows 7/8.1/10. Infinitt PACS 7.0 is anintegral component of INFINITT'scomplete INFINITT PACS/RIS solution.Infinitt PACS 7.0 fully supports DICOMstandards and such functions as advancedDICOM viewing, Hanging Protocol,various 3D display such as MPR, VolumeRendering, MIP and fusion. Infinitt PACS7.0 allows users to take full advantage ofthe radiographic images from variousmodalities in order to obtain invaluablemission critical diagnostic data and images.With Infinitt PACS 7.0, users can accesstheir own diagnostic environmentanywhere, anytime. This is made possiblebecause Infinitt PACS 7.0 is deployedthrough a network and supports hangingprotocol. Also, Infinitt PACS 7.0 usesJPEG 2000 features so that it takes lesstime to transfer images through a network.Infinitt PACS 7.0 is based upon theINFINITT 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 listautomatically by user configuration• Supports create/edit/delete searchfolders that contains the predefinedsearch conditions• Exam list are configurable – fontname, size, color• Changes exam status using hospitalspecific terminology• information using External link• Opens an exam or multiple exams inone click• Opens only key images in the selectedexam• Scans documents and attaches to theselected exam• Limit data access (Passcode Rule,Hiding rule, Folder Lock)• Supports creating and view thecomments of the study for private-useor sharing with specified user level.• Assigns the priority of the study• Assigns the referring doctor of thestudy• Assigns the Radiologist (Read doctor)of the study• Creates and shows technician note• Searches the historical exams of theselected exam• Creates and shows the report of theselected exam | • Supports refreshing the exam listautomatically by user configuration• Exports the list of the selected examsto text file or MS Excel compatible file(CSV)• Supports create/edit/delete searchfolders that contains the predefinedsearch conditions• Caches the images to the local diskwith On-Call function• Exam list are configurable - fontname, size, color• Changes exam status using hospitalspecific terminology• Launches the 3rd party application orweb URL with selected examinformation using External link• Opens an exam or multiple exams inone click• Opens only key images in the selectedexam• Scans documents and attaches to theselected exam• Limit data access (Passcode Rule,Hiding rule, Folder Lock)• Supports creating and view thecomments of the study for private-useor sharing with specified user level.• Assigns the priority of the study• Assigns the referring doctor of thestudy• Assigns the Radiologist (Read doctor)of the study• Creates and shows technician note• Creates and shows ER note• Searches the historical exams of theselected exam• Creates and shows the report of theselected exam | ||
| Favorite folder | Favorite folder | ||
| • Creates, edits and deletes the folderthat are containing the interestingexams.• Adds interesting exam to specifiedfolder by mouse dragging from Studylist or creating snapshot for favoritefolder.• Also, supports common functions for | • Creates, edits and deletes the folderthat are containing the interestingexams.• Supports sharing with another user• Adds interesting exam to specifiedfolder by mouse dragging from Studylist or creating snapshot for favoritefolder. | ||
| exam in Study listDICOM QR• Supports the list of exams retrieved by | • Also, supports common functions forexam in Study listDICOM QR• Supports the list of exams retrieved by | ||
| DICOM query from DICOMcompatible station.• Supports send the selected exam toother station. | DICOM query from DICOMcompatible station.• Supports send the selected exam toother 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 seriesEmbedded web browserBrowses 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 storageAccesses 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 HangingProtocol | 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 | |||
| 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 withtemplate Dictation | General Supports Built-in report module Support displaying the information ofthe reading exams Supports Reading workflow Supports temporally suspending thereport Supports merging the reports ofmultiple unread exams of a patient Supports printing the text report withtemplate Dictation Dictation Stores the voice with MP3 voice fileformat and updates the exam status forit. Interface with Philips Speech Mikecontroller Text Report Text Report Displays the reading history who andwhen creates, updates and approvesthe report Displays a report of historical examsof the patient and copy the text from it Displays a predefined report templateand copy the text from it (Standardreport) 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 andwhen creates, updates and approvesthe report Displays a report of historical examsof the patient and copy the text from it Displays a predefined report templateand copy the text from it (Standardreport) Supports user-defined standard report |
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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 measurementrange for passing |
|---|---|
| LengthTapeline | 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 squarecentimeters |
|---|---|
| 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.
§ 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).