Quantor View is PACS image viewing software for DICOM images produced by imaging equipment (CR, DR, CT, MRI, Ultrasound and etc). The software allows physicians to provide medical services by accessing image data and patient information from remote locations. It also enables the images to be stored to the local database of your personal computer allowing database management to operate efficiently. Physicians can utilize the software tools for viewing, researching, teaching, teleconferencing and online collaboration.

Device Description

This is a PC software product used for viewing digital medical images having the following features: DICOM File Support (Read and display all DICOM files (mono-frame, multi-frame), Read and display non-DICOM file (JPEG Lossy, JPEG Lossless, JPEG2000, RLE), Read and write DICOM CD/DVD (DICOMDIR support), Export DICOM files to BMP, TIFF, JPEG, Convert Non-DICOM images to DICOM, Convert multi-frame image to AVI file), DICOM Network Support (DICOM Storage SCU/SCP, DICOM Query/Retrieve SCU/ SCP, DICOM Print SCU with 8, 12 bit support), Viewer Functions (Customizable toolbars, NN, linear, cubic, super sampling interpolation, ROIs: polygons, circles, rectangles and etc., Custom LUT and curve, CT/MR scout line view, Thumbnail images support, Support 1 to 4 monitors, User defined hanging protocol, tool bar, overlay, Local database support, Local backup support).

AI/ML Overview

This document describes the QuantorView, a Picture Archiving and Communications System (PACS) software, seeking 510(k) clearance. The submission relies on demonstrating substantial equivalence to a predicate device, the eFilm Workstation (K012211). Therefore, the core of the "study that proves the device meets the acceptance criteria" is primarily focused on non-clinical performance testing to show that QuantorView functions comparably to the predicate and adheres to relevant standards.

Here's a breakdown of the requested information based on the provided text, recognizing that a 510(k) for a PACS viewing software typically does not involve clinical performance studies in the same way an AI diagnostic algorithm would.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a substantial equivalence submission for PACS viewing software, the "acceptance criteria" are primarily defined by the functional equivalence to the predicate device and compliance with relevant standards.

Acceptance Criteria (Implied)	Reported Device Performance (QuantorView)
Functional Equivalence to Predicate Device (eFilm Workstation)	Declared Substantially Equivalent: "All technical and functional characteristics of the predicate and the QuantorView product are essentially the same, including the platform and DICOM image compatibility."
View Medical Images	PACS image viewing software for DICOM images (CR, DR, CT, MRI, Ultrasound, etc.), enabling viewing of digital medical images.
DICOM File Support	Reads and displays all DICOM files (mono-frame, multi-frame); reads and displays non-DICOM files (JPEG Lossy, JPEG Lossless, JPEG2000, RLE); reads and writes DICOM CD/DVD (DICOMDIR support); exports DICOM files to BMP, TIFF, JPEG; converts non-DICOM to DICOM; converts multi-frame to AVI. (Matches or exceeds predicate).
DICOM Network Support	DICOM Storage SCU/SCP, DICOM Query/Retrieve SCU/SCP, DICOM Print SCU with 8, 12 bit support. (Matches predicate).
Viewer Functions (Manipulation, Measurement)	Customizable toolbars, NN, linear, cubic, super sampling interpolation, ROIs (polygons, circles, rectangles, etc.), custom LUT and curve, CT/MR scout line view, thumbnail images, support for 1 to 4 monitors, user-defined hanging protocol, toolbar, overlay, local database support, local backup support. (Matches or exceeds predicate for image manipulation like rotate, flip, invert, and measurements like distance, angle, CTR).
Operating System Compatibility	Windows 7 or 8. (Comparable to predicate's Windows XP, Vista, Windows 7).
DICOM 3.0 Compliance	DICOM 3.0 Compliant. (Matches predicate). Tested and verified compliance with the DICOM 3 compliance statement.
Software Validation & Risk Analysis	Software validation and risk analysis done according to FDA Guidance document: "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices Document issued on: May 11, 2005". Testing verified compliance. Off-the-Shelf Software and Device Security issues addressed and documented. A Manufacturer Disclosure Statement for Medical Device Security (MDS) has been executed.

2. Sample Size Used for the Test Set and Data Provenance

Test Set Sample Size: The document does not specify a quantitative "test set sample size" in terms of number of patient cases or images for clinical performance. As this is PACS viewing software, the testing would focus on the software's ability to correctly display and manipulate various types of DICOM images. This would likely involve a diverse set of DICOM files covering different modalities (CR, DR, CT, MRI, Ultrasound, etc.) and image characteristics to ensure proper handling and viewing functionalities. However, no specific number is provided.
Data Provenance: Not explicitly stated as this is not a clinical study involving patient data from a specific region. The testing would involve generic DICOM files, potentially simulated or anonymized, to test the software's functionality and compliance.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not applicable or provided for this type of submission. Ground truth establishment with experts is typically for diagnostic AI algorithms where a clinical finding is being evaluated. For PACS viewing software, the "ground truth" is adherence to DICOM standards and accurate representation of image data.

4. Adjudication Method for the Test Set

Not applicable or provided. Adjudication methods like 2+1 or 3+1 are used in clinical studies with human readers to resolve discrepancies in diagnoses or interpretations. This is not a clinical study evaluating diagnostic performance.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. The document explicitly states: "Clinical performance testing: Not applicable or required." MRMC studies are used to evaluate the impact of a device (often AI) on human reader performance, which is not the focus of a PACS viewing software 510(k).

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done

Standalone technical performance testing was done. The software itself was tested to ensure it met its functional specifications and complied with DICOM standards. This is evident from "Non-clinical performance testing. Software validation and risk analysis was done... Testing verified compliance with the DICOM 3 compliance statement has been executed." However, this is not a standalone diagnostic algorithm performance evaluation, but rather a standalone software functionality evaluation.

7. The Type of Ground Truth Used

The "ground truth" for this device's evaluation is primarily technical compliance and adherence to established standards, specifically:
- DICOM 3.0 Compliance: Ensuring the software correctly interprets, displays, and handles DICOM files according to the standard.
- Functional Specifications: Verifying that all advertised features (image manipulation, measurement, network support, etc.) work as intended.
- Predicate Device Functionality: Demonstrating that QuantorView performs equivalently to the legally marketed eFilm Workstation.

8. The Sample Size for the Training Set

Not applicable or provided. This device is PACS viewing software, not an AI/machine learning algorithm that requires a "training set" in the conventional sense. The software's capabilities are based on coded logic and adherence to standards, not on learning from a dataset.

9. How the Ground Truth for the Training Set was Established

Not applicable. As there is no training set for an AI algorithm, there is no ground truth established for it.

Summary

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

August 3, 2015

3DISC Americas % Mr. Daniel Kamm Principal Engineer Kamm and Associates 8870 Ravello Court NAPLES FL 34114

Re: K151687

Trade/Device Name: QuantorView Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: June 16, 2015 Received: June 23, 2015

Dear Mr. Kamm:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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

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

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

Robert A Ochs

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

Enclosure

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Indications for Use

510(k) Number (if known) K151687

Device Name QuantorView

Indications for Use (Describe)

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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510(k) Summary K15

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

Date prepared: June 16, 2015

1. Company and Correspondent making the submission:
  Name - 3D Imaging & Simulations Corp. Address – 815, Tamnip-Dong, Yuseong-Gu, Daejeon, Korea Telephone - +82-42-931-2100 Fax — +82-42-931-2299 Contact – Jiin Jung / Vice President E-mail – jiinjung@3-disc.com
1. Device :

Trade/proprietary name:	QuantorView
Common Name:	PACS Software
Classification Name:	Picture Archiving and Communications System

1. Predicate Device :

Manufacturer:	eFilm.
Device:	eFilm Workstation
510(k) Number:	K012211

1. Classifications Names & Citations :
  21CFR 892.2050, LLZ – Picture Archiving and Communications System, Class 2
1. Description : This is a PC software product used for viewing digital medical images having the following features:

DICOM File Support

Read and display all DICOM files (mono-frame, multi-frame) ●
Read and display non-DICOM file
JPEG Lossy, JPEG Lossless, JPEG2000, RLE
Read and write DICOM CD/DVD (DICOMDIR support)
Export DICOM files to BMP, TIFF, JPEG
Convert Non-DICOM images to DICOM
Convert multi-frame image to AVI file.

DICOM Network Support

o DICOM Storage SCU/SCP
0 DICOM Query/Retrieve SCU/ SCP
DICOM Print SCU with 8, 12 bit support 0

Viewer Functions

Customizable toolbars
NN, linear, cubic, super sampling interpolation
0 ROIs: polygons, circles, rectangles and etc.

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Custom LUT and curve 0
0 CT/MR scout line view
Thumbnail images support
Support 1 to 4 monitors
User defined hanging protocol, tool bar, overlay
Local database support
Local backup support
1. Indications for use :

QuantorView is PACS image viewing software for DICOM images produced by imaging equipment (CR, DR, CT, MRI, Ultrasound and etc). The software allows physicians to provide medical services by accessing image data and patient information from remote locations. It also enables the images to be stored to the local database of your personal computer allowing database management to operate efficiently. Physicians can utilize the software tools for viewing, researching, teaching, teleconferencing and online collaboration.

1. Comparison with predicate device :
  3D Imaging & Simulations Corp. believes that the QuantorView is substantially equivalent to eFilm Workstation.

	eFilm WorkstationeFilm Medical, Inc (Now known as MergeHealthcare) K012211	QuantorView3D Imaging & Simulations Corp.
IntendedUse	eFilmTM Workstation is a software application that isused for viewing medical images. eFilmTMWorkstation receives digital images and data fromvarious sources (including but not limited to CT, MR,US, RF units, computed and direct radiographicdevices, secondary capture devices, scanners,imaging gateways or imaging sources). Images arestored, communicated, processed and displayed onthe local disc of a workstation and/or acrosscomputer networks at distributed locations. Tasksthat users may perform when viewing imagesinclude, but are not limited to: adjustment ofwindow width and level; image stacking; annotationand measurement of regions of interest; andinversion, rotation, and flips of images. In addition,eFilmTM Workstation can be integrated with aninstitution's existing HIS or RIS for a fully integratedelectronic patient record. Typical users of eFilmTMWorkstation are trained medical professionals,including but not limited to radiologists, clinicians,technologists, and others.	QuantorView is PACS image viewingsoftware for DICOM images producedby imaging equipment (CR, DR, CT,MRI, Ultrasound and etc). Thesoftware allows physicians to providemedical services by accessing imagedata and patient information fromremote locations. It also enables theimages to be stored to the localdatabase of your personal computerallowing database management tooperate efficiently. Physicians canutilize the software tools for viewing,researching, teaching,teleconferencing and onlinecollaboration.
OperationalCharacteristics	Uses PC computers running WindowsXP, Vista, Windows 7.	SAME, Windows 7 or 8

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	eFilm WorkstationeFilm Medical, Inc (Now known as MergeHealthcare) K012211	QuantorView3D Imaging & Simulations Corp.
Typical Users	Trained medical professionals, including but notlimited to radiologists, clinicians, technologists, andothers.	SAME
IMAGEMANIPULATION	Rotate, flip, and invert images	SAME
MEASUREMENT	Distance, angle, CTR	SAME
CD/DVDBurning	YES	YES
DICOM Print	YES, regular or DICOM printer	SAME
IMPORT Images	Both DICOM and NON-DICOM (JPEG and TIFF)	SAME
Export Images	Export images as JPEG filesExport images as AVI files	SAME, plus BMP and TIFF
Backup	YES	YES, auto and manual
Medical DeviceSecurity - MDS	Not specified	Disclosure Statement Executed
Connection	Ethernet	SAME
DICOMCompatibility	DICOM 3.0 Compliant	DICOM 3.0 Compliant
DICOM FILESUPPORT	JPEG Lossy, JPEG Lossless, JPEG2000	JPEG Lossy, JPEG Lossless, JPEG2000,RLE (Run Length Encoding)

Summary of comparison: All technical and functional characteristics of the predicate and the QuantorView product are essentially the same, including the platform and DICOM image compatibility. Therefore the QuantorView software product is substantially equivalent to the legally marketed predicate.

1. Non-clinical performance testing. Software validation and risk analysis was done according to FDA Guidance document: Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices Document issued on: May 11, 2005. Testing verified compliance with the DICOM 3 compliance statement has been executed. Off-the Shelf Software and Device Security issues were addressed and documented. A Manufacturer Disclosure Statement for Medical Device Security – MDS – has been executed.
1. Clinical performance testing: Not applicable or required.
1. In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this premarket notification 3D Imaging & Simulations Corp. concludes that the QuantorView software is safe and effective and substantially equivalent to predicate device as described herein.

Regulation Number and Section

§ 892.2050 Medical image management and processing system.

(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).