SaintView

K223660 · Inviz Corporation · LLZ · Aug 14, 2023 · Radiology

Device Facts

• Record ID: K223660
• Device Name: SaintView
• Applicant: Inviz Corporation
• Product Code: LLZ · Radiology
• Decision Date: Aug 14, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended 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.

Device Story

SaintView is a medical image management and processing system used in hospitals. It receives medical images and data from various imaging sources; stores, communicates, processes, and displays them across networks. Features include image viewing, zooming, rotating, and length/angle/area/volume measurements to aid reading. It supports DICOM standards for reception, transmission, CD creation, and printing. The system includes a worklist, high-resolution monitor support, and software division for large monitors. Operated by trained professionals (radiologists, physicians, technicians) in clinical settings. The device does not control life-sustaining equipment or provide automated diagnostic assistance; it serves as a tool for clinicians to interpret images, with diagnostic decisions remaining solely with the physician. Benefits include efficient image access, standardized viewing, and measurement tools to support clinical workflow.

Clinical Evidence

Bench testing only. Performance evaluated using standardized AAPM CT phantom. Measurement accuracy tests confirmed errors within specified tolerances: length (±0.03mm), ROI (±0.01 sq in), area (±0.01 sq cm), and volume (±0.15 mm3). Software validation performed.

Technological Characteristics

Software-based medical image management system. Operates on Microsoft Windows 8/10 (32/64 bit). Supports DICOM 3.x standards (Storage SCP/SCU, Query/Retrieve, JPEG/JPEG2K compression, Print). Features include hanging protocols, measurement tools, and multi-monitor support. Cybersecurity controls include access control, authentication, password protection, and firmware/software integrity verification.

Indications for Use

Indicated for trained professionals (physicians, radiologists, nurses, technicians) to store, communicate, process, and display medical images/data. Mammography primary diagnosis restricted to preprocessed DICOM for presentation images on FDA-compliant monitors; lossy compressed or digitized film-screen images prohibited for primary interpretation.

Regulatory Classification

Identification

A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.

Special Controls

*Classification.* Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).

Predicate Devices

• Infinitt PACS 7.0 (K172803)

Submission Summary (Full Text)

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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,

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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 that<br>receives medical images and data from<br>various imaging sources. Images and data<br>can be stored, communicated, processed,<br>and displayed within the system or across<br>computer networks at distributed<br>locations. Only preprocessed DICOM for<br>presentation images can be interpreted for<br>primary image diagnosis in<br>mammography. Lossy compressed<br>mammographic images and digitized film<br>screen images must not be reviewed for<br>primary image interpretations. | Infinitt PACS 7.0TM, is a software device<br>that receives medical images and data from<br>various imaging sources. Images and data<br>can be stored, communicated, processed,<br>and displayed within the system or across<br>computer networks at distributed locations.<br>Only preprocessed DICOM for presentation<br>images can be interpreted for primary<br>image diagnosis in mammography. Lossy<br>compressed mammographic images and<br>digitized film screen images must not be<br>reviewed for primary image interpretations.<br>Mammographic images may only be | |
| | Mammographic images may only be<br>interpreted using a monitor that meets<br>technical specification identified by FDA.<br>Typical users of this system are trained<br>professionals, e.g. physicians, radiologists,<br>nurses, and medical technicians. | interpreted using a monitor that meets<br>technical specification identified by FDA.<br>Typical users of this system are trained<br>professionals, e.g. physicians, radiologists,<br>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,<br>analyzing, recording diagnosis and storing<br>images of medical images generated for<br>diagnosis in hospitals. It has functions<br>such as storing, transmitting, viewing,<br>zooming in, reducing, moving and rotating<br>medical images, as well as measuring<br>length to aid in reading, and displaying<br>various tools and reference positions. This<br>product has a worklist for ease of reading,<br>support for high-resolution medical<br>monitors, and software division function<br>for large monitors. In addition, it supports<br>DICOM standard so that DICOM video<br>can be checked in the viewer, and DICOM<br>standard is also supported for video<br>reception, transmission, CD creation, and<br>printing. | Infinitt PACS 7.0TM device is PACS<br>software capable of viewing and handling<br>DICOM 3.x medical images. The System<br>allows displaying of images and image<br>studies that may not in the location as the<br>modality. With its Web features, it is<br>possible to review, modify, and approve<br>studies located in a remote server.<br>INFINITT PACS is a software device that<br>does not contact the patient, nor does it<br>control any life sustaining devices. The<br>software does not provide any diagnostic<br>assistance to the physician. Any diagnostic<br>determination or treatment is solely<br>determined by a 510(k) Summary of Safety<br>and Effectiveness Infinitt PACS 7.0TM 2<br>physician and not the software. A<br>physician, providing ample opportunity for<br>competent human intervention, interprets<br>images and information being displayed<br>and printed.<br>Infinitt PACS 7.0 is a web-based, 3D-<br>enabled DICOM view station running on<br>Windows 7/8.1/10. Infinitt PACS 7.0 is an<br>integral component of INFINITT's<br>complete INFINITT PACS/RIS so…