(41 days)
Not Found
No
The document describes standard PACS image viewing software with typical features and does not mention any AI or ML capabilities.
No
The device is described as PACS image viewing software, providing tools for viewing, managing, and exchanging medical images. Its function is to display image data and patient information, not to directly treat or diagnose a medical condition.
No
The device is described as PACS image viewing software, enabling physicians to view, store, and manage medical images. It does not perform analysis or interpretation of images to diagnose conditions.
Yes
The device description explicitly states it is a "PC software product" and details only software functionalities related to viewing, managing, and networking DICOM images. There is no mention of any accompanying hardware components or hardware-specific validation.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the software is for viewing and managing medical images produced by imaging equipment (CR, DR, CT, MRI, Ultrasound, etc.). It allows physicians to access and utilize these images for medical services, research, teaching, teleconferencing, and collaboration. This is focused on the interpretation and management of in vivo imaging data, not in vitro diagnostic testing.
- Device Description: The features described are all related to the handling, display, and management of medical images. There is no mention of analyzing biological samples, reagents, or any other components typically associated with in vitro diagnostics.
- Lack of IVD-Specific Information: The document does not contain any information related to the analysis of biological samples, performance metrics relevant to IVD testing (like sensitivity, specificity for a specific analyte), or any other indicators of an IVD device.
In summary, the device is a PACS image viewing software, which falls under the category of medical imaging software, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
LLZ
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
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CR, DR, CT, MRI, Ultrasound and etc.
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physicians, Trained medical professionals, including but not limited to radiologists, clinicians, technologists, and others.
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)
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.
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 & Human Services. The logo consists of a stylized caduceus, which is a symbol often associated with medicine and healthcare. The caduceus is composed of three intertwined strands, resembling snakes or ribbons, and a single wing extending from the top. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus.
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) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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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
-
- 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
- Company and Correspondent making the submission:
-
- Device :
| Trade/proprietary name: | QuantorView |
|---|---|
| Common Name: | PACS Software |
| Classification Name: | Picture Archiving and Communications System |
-
- Predicate Device :
| Manufacturer: | eFilm. |
|---|---|
| Device: | eFilm Workstation |
| 510(k) Number: | K012211 |
-
- Classifications Names & Citations :
21CFR 892.2050, LLZ – Picture Archiving and Communications System, Class 2
- Classifications Names & Citations :
-
- 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
-
- 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.
-
- Comparison with predicate device :
3D Imaging & Simulations Corp. believes that the QuantorView is substantially equivalent to eFilm Workstation.
- Comparison with predicate device :
| | eFilm Workstation
eFilm Medical, Inc (Now known as Merge
Healthcare) K012211 | QuantorView
3D Imaging & Simulations Corp. |
|--------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended
Use | eFilmTM Workstation is a software application that is
used for viewing medical images. eFilmTM
Workstation receives digital images and data from
various sources (including but not limited to CT, MR,
US, RF units, computed and direct radiographic
devices, secondary capture devices, scanners,
imaging gateways or imaging sources). Images are
stored, communicated, processed and displayed on
the local disc of a workstation and/or across
computer networks at distributed locations. Tasks
that users may perform when viewing images
include, but are not limited to: adjustment of
window width and level; image stacking; annotation
and measurement of regions of interest; and
inversion, rotation, and flips of images. In addition,
eFilmTM Workstation can be integrated with an
institution's existing HIS or RIS for a fully integrated
electronic patient record. Typical users of eFilmTM
Workstation are trained medical professionals,
including but not limited to radiologists, clinicians,
technologists, and others. | 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. |
| Operational
Characteristics | Uses PC computers running Windows
XP, Vista, Windows 7. | SAME, Windows 7 or 8 |
5
| | eFilm Workstation
eFilm Medical, Inc (Now known as Merge
Healthcare) K012211 | QuantorView
3D Imaging & Simulations Corp. |
|----------------------------------|------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------|
| Typical Users | Trained medical professionals, including but not
limited to radiologists, clinicians, technologists, and
others. | SAME |
| IMAGE
MANIPULATION | Rotate, flip, and invert images | SAME |
| MEASUREMENT | Distance, angle, CTR | SAME |
| CD/DVD
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
Export images as AVI files | SAME, plus BMP and TIFF |
| Backup | YES | YES, auto and manual |
| Medical Device
Security - MDS | Not specified | Disclosure Statement Executed |
| Connection | Ethernet | SAME |
| DICOM
Compatibility | DICOM 3.0 Compliant | DICOM 3.0 Compliant |
| DICOM FILE
SUPPORT | 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.
-
- 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.
-
- Clinical performance testing: Not applicable or required.
-
- 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.