QuantorView

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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. {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 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 {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K151687 Device Name QuantorView #### Indications for Use (Describe) 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. | Type of Use (Select one or both, as applicable) | | |---------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------| | <span style="unicode-bidi:isolate; direction:ltr">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="unicode-bidi:isolate; direction:ltr">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) | ### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # 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 - 2. Device : | Trade/proprietary name: | QuantorView | |-------------------------|---------------------------------------------| | Common Name: | PACS Software | | Classification Name: | Picture Archiving and Communications System | - 3. Predicate Device : | Manufacturer: | eFilm. | |----------------|-------------------| | Device: | eFilm Workstation | | 510(k) Number: | K012211 | - 4. Classifications Names & Citations : 21CFR 892.2050, LLZ – Picture Archiving and Communications System, Class 2 - 5. 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. {4}------------------------------------------------ - 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 - 6. 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. - 7. Comparison with predicate device : 3D Imaging & Simulations Corp. believes that the QuantorView is substantially equivalent to eFilm Workstation. | | eFilm Workstation<br>eFilm Medical, Inc (Now known as Merge<br>Healthcare) K012211 | QuantorView<br>3D Imaging & Simulations Corp. | |--------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended<br>Use | eFilmTM Workstation is a software application that is<br>used for viewing medical images. eFilmTM<br>Workstation receives digital images and data from<br>various sources (including but not limited to CT, MR,<br>US, RF units, computed and direct radiographic<br>devices, secondary capture devices, scanners,<br>imaging gateways or imaging sources). Images are<br>stored, communicated, processed and displayed on<br>the local disc of a workstation and/or across<br>computer networks at distributed locations. Tasks<br>that users may perform when viewing images<br>include, but are not limited to: adjustment of<br>window width and level; image stacking; annotation<br>and measurement of regions of interest; and<br>inversion, rotation, and flips of images. In addition,<br>eFilmTM Workstation can be integrated with an<br>institution's existing HIS or RIS for a fully integrated<br>electronic patient record. Typical users of eFilmTM<br>Workstation are trained medical professionals,<br>including but not limited to radiologists, clinicians,<br>technologists, and others. | QuantorView is PACS image viewing<br>software for DICOM images produced<br>by imaging equipment (CR, DR, CT,<br>MRI, Ultrasound and etc). The<br>software allows physicians to provide<br>medical services by accessing image<br>data and patient information from<br>remote locations. It also enables the<br>images to be stored to the local<br>database of your personal computer<br>allowing database management to<br>operate efficiently. Physicians can<br>utilize the software tools for viewing,<br>researching, teaching,<br>teleconferencing and online<br>collaboration. | | Operational<br>Characteristics | Uses PC computers running Windows<br>XP, Vista, Windows 7. | SAME, Windows 7 or 8 | {5}------------------------------------------------ | | eFilm Workstation<br>eFilm Medical, Inc (Now known as Merge<br>Healthcare) K012211 | QuantorView<br>3D Imaging & Simulations Corp. | |----------------------------------|------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------| | Typical Users | Trained medical professionals, including but not<br>limited to radiologists, clinicians, technologists, and<br>others. | SAME | | IMAGE<br>MANIPULATION | Rotate, flip, and invert images | SAME | | MEASUREMENT | Distance, angle, CTR | SAME | | CD/DVD<br>Burning | 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 files<br>Export images as AVI files | SAME, plus BMP and TIFF | | Backup | YES | YES, auto and manual | | Medical Device<br>Security - MDS | Not specified | Disclosure Statement Executed | | Connection | Ethernet | SAME | | DICOM<br>Compatibility | DICOM 3.0 Compliant | DICOM 3.0 Compliant | | DICOM FILE<br>SUPPORT | JPEG Lossy, JPEG Lossless, JPEG2000 | JPEG Lossy, JPEG Lossless, JPEG2000,<br>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. - 8. 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. - 9. Clinical performance testing: Not applicable or required. - 10. 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.