(30 days)
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Not Found
No
The summary describes standard medical image processing and analysis tools without mentioning AI or ML.
No.
The device is intended to aid physicians, clinicians, and radiologists in reading and interpreting medical images for diagnostic purposes, not to directly treat a disease or condition.
Yes
The device is described as providing "tools to aid them in reading and interpreting DICOM compliant tomographic medical imaging," and specifically mentions "Specialist tools and workflow enhancements for specific clinical applications which provide targeted workflows, custom UI, targeted measurement and reporting functions including Colon Screening (which is intended for the screening of patients for colonic polyps, tumours and other lesions using tomographic Colonography), Calcium Scoring (which is intended for non-invasive identification and quantification of calcified atherosclerotic plaques in the coronary arteries using tornographic medical image data and clinically accepted calcium scoring algorithms), Vessel Analysis (which is intended for the qualitative and quantitative analysis of tomographic angiographic studies to evaluate occlusive and aneurysmal disease)." These functions directly support the process of identifying diseases or conditions, which is the definition of a diagnostic device.
Unknown
The provided text describes the intended use and functionality of the Voxar 3D product family, which is clearly software for medical image analysis. However, the "Device Description" section is missing, which would typically confirm if the device is solely software or includes associated hardware. Without this information, it's impossible to definitively state if it's a software-only medical device.
Based on the provided information, the Voxar 3D product family is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens taken from the human body. The intended use of the Voxar 3D product family is to aid physicians, clinicians, and radiologists in reading and interpreting medical images (DICOM compliant tomographic imaging). This involves analyzing images of the body, not analyzing samples taken from the body.
- The description focuses on image analysis tools and workflows. The listed functionalities are all related to processing, visualizing, and analyzing medical images. There is no mention of analyzing blood, urine, tissue, or any other biological specimen.
Therefore, based on the provided text, the Voxar 3D product family falls under the category of medical imaging software or a medical image analysis system, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Voxar 3D product family is a suite of products that is intended to provide Physicians, Clinicians and Radiologists with tools to aid them in reading and interpreting DICOM compliant tomographic medical imaging.
The Voxar 3D product family provides several levels of functionality to the user :-
- Basic analysis tools they use on a daily basis, such as 2D review, orthogonal Multi Planar ● Reconstructions (MPRs), oblique MPRs, curved/cross-curved MPRs, slab MPRs, AvelP, MIP, MinIP, measurements, annotations, reporting, distribution, etc
- Tools for in-depth analysis, such as segmentation, endoscopic review, colour VR slab, 3D . volume review, path definition and boundary detection, PET imagery analysis, etc
- Specialist tools and workflow enhancements for specific clinical applications which . provide targeted workflows, custom UI, targeted measurement and reporting functions including Colon Screening (which is intended for the screening of patients for colonic polyps, tumours and other lesions using tomographic Colonography), Calcium Scoring (which is intended for non-invasive identification and quantification of calcified atherosclerotic plaques in the coronary arteries using tornographic medical image data and clinically accepted calcium scoring algorithms), Vessel Analysis (which is intended for the qualitative and quantitative analysis of tomographic angiographic studies to evaluate occlusive and aneurysmal disease), etc.
Product codes
LLZ
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
DICOM compliant tomographic medical imaging
Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
Physicians, Clinicians and Radiologists
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized emblem featuring three abstract shapes resembling birds in flight, arranged in a cascading manner.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 9 2006
Mr. Neil Phillips Quality and Regulatory Manager BarcoView MIS Edinburgh Bonnington Bond, 2 Anderson Place Edinburgh, Lothian, EH6 5NP UNITED KINGDOM
Re: K060505
Trade/Device Name: Voxar 3D Product Family Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ
Dated: February 23, 2006 Received: February 27, 2006
Dear Mr. Phillips:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such 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); 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
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits wour device (o proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
- Nancy C. Brigdon
Nancv C. Brogdon Director, Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications For Use
Applicant:
Voxar Ltd, Bonnington Bond, 2 Anderson Place, Edinburgh, EH6 5NP, UK.
510(k) Number (if known): ROG 0505
Unknown
Device Name:
Voxar 3D Product Family
Indications For Use:
The Voxar 3D product family is a suite of products that is intended to provide Physicians, Clinicians and Radiologists with tools to aid them in reading and interpreting DICOM compliant tomographic medical imaging.
The Voxar 3D product family provides several levels of functionality to the user :-
- Basic analysis tools they use on a daily basis, such as 2D review, orthogonal Multi Planar ● Reconstructions (MPRs), oblique MPRs, curved/cross-curved MPRs, slab MPRs, AvelP, MIP, MinIP, measurements, annotations, reporting, distribution, etc
- Tools for in-depth analysis, such as segmentation, endoscopic review, colour VR slab, 3D . volume review, path definition and boundary detection, PET imagery analysis, etc
- Specialist tools and workflow enhancements for specific clinical applications which . provide targeted workflows, custom UI, targeted measurement and reporting functions including Colon Screening (which is intended for the screening of patients for colonic polyps, tumours and other lesions using tomographic Colonography), Calcium Scoring (which is intended for non-invasive identification and quantification of calcified atherosclerotic plaques in the coronary arteries using tornographic medical image data and clinically accepted calcium scoring algorithms), Vessel Analysis (which is intended for the qualitative and quantitative analysis of tomographic angiographic studies to evaluate occlusive and aneurysmal disease), etc.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
David R. Lynn
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices K060505
510(k) Number
Prescription Use
(21 CFR 801.109)
OR
Over-The-counter Use