(66 days)
No
The document describes image registration software and explicitly states "Not Found" for mentions of AI, DNN, or ML. The description focuses on traditional image processing techniques for alignment.
No.
The device is described as a software program that registers pairs of volumetric images to aid clinicians in understanding joint information, but it explicitly states that the clinician retains ultimate responsibility for diagnosis and it is a complement, not a replacement, for standard procedures. It falls under "Image Processing System" and is described as a "Picture Archiving and Communications System," which are diagnostic, not therapeutic, tools.
No
The device is an image processing system that helps clinicians compare image volume data, but the manufacturer explicitly states that the clinician retains the ultimate responsibility for diagnosis and that the device is a complement to standard procedures, not a diagnostic tool itself.
Yes
The device description explicitly states that Fusion7D is a "software program running on a PC platform" and describes its functionalities as software-based image processing and display. There is no mention of accompanying hardware components that are part of the device itself.
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 Fusion7D registers and displays images to ease the comparison of image volume data by the clinician and help the clinician obtain a better understanding of the joint information. It explicitly states that the clinician retains the ultimate responsibility for making the pertinent diagnosis and that Fusion7D is a complement to these standard procedures. This indicates that the device is providing information to aid the clinician's interpretation of existing diagnostic images, rather than performing a test on a biological specimen to provide diagnostic information itself.
- Device Description: The description focuses on software for image registration, display, and manipulation. It does not mention any interaction with biological samples or the analysis of biological markers.
- Mentions image processing: The classification as "Image Processing System" further supports its role in manipulating and presenting images, not performing in vitro tests.
- Input Imaging Modality: The input modalities are medical imaging techniques (MRI, CT, SPECT, PET), which produce images of the body, not results from tests on biological samples.
IVD devices are typically used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. Fusion7D operates on existing medical images, which are not biological specimens in the context of IVD regulation.
N/A
Intended Use / Indications for Use
Fusion7D registers pairs of anatomical and functional volumetric images (e.g. MRI-SPECT, MRI-PET, CT-SPECT, CT-PET), or pairs of anatomical volumetric images (e.g. MRI-MRI, CT-CT and MRI-CT) as a means to ease the comparison of image data. The result of the registration operation aims to help the clinician obtain a better understanding of the joint information that would otherwise have to be compared visually. This is useful for a wide range of clinical and therapeutic applications. It is important to note that the clinician retains the ultimate responsibility for making the pertinent diagnosis based on their standard procedures, including visual comparison of the separate unregistered images. Fusion7D is a complement to these standard procedures.
Product codes
LLZ
Device Description
Fusion7D is a software program running on a PC platform, which brings into alignment (registers) pairs of images from different imaging modalities. Fusion7D also includes functionality to read, display, and save the original volumetric data and the results of the registration operation by means of a graphic user interface that includes visualization, file browsing and control of input and output as described in the following text.
Medical images can be divided into anatomical images (e.g. CT and conventional MRI), and functional images (e.g. SPECT and PET). Fusion7D provides two registration solutions: 1. It enables the comparison of pairs of anatomical images (to assess changes in anatomical structures) and 2. It correlates the structures seen in an anatomical dataset with the activity detected in functional images.
The registration operation can be a) manual: whereby the user defines the transformation that brings the two datasets into as close alignment as possible, b) semi-automatic: in which the user inputs a series of landmarks in one dataset and the software provides matching landmarks in the other, and c) automatic: in which the software requires no user input and finds the transformation between the two datasets based on the characteristics of the images. In all these cases the transformation is limited to a rigid body deformation (i.e. 3D translation and rotation).
The Fusion7D software incorporates standard visualization facilities to visualize the input DICOM data and the results of the registration operations. This simple visualization GUI includes:
- orthogonal and any-plane slicing of the volumetric data (but no 3D reconstruction), .
- . whole and region of interest zooming,
- panning. .
- . window and level controls,
- image overlays for which the transparency, threshold and colormap is user controlled. ●
The Fusion7D software allows the registration results to be displayed in a variety of ways including: the overlay of one dataset on another, the simultaneous binding of cursors in two volumes and the generation of a split pane image.
Mentions image processing
Yes
Mentions AI, DNN, or ML
No
Input Imaging Modality
MRI, CT, PET, SPECT
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
clinician
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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
FUSION 7D 510(K) SUMMARY SECTION
| Date: | 7th February, 2002 |
|---|---|
| Submitters Name: | Mirada Solutions Ltd. |
| Submitters Name: | Oxford Centre for Innovation. |
| Mill Street, Oxford OX2 OJX, United Kingdom. | |
| Submitters Contact: | Dr. Nick Cerneaz, VP Engineering. |
| Tel: 44-1865-811125 Fax: 44-1865-793165 | |
| Submitters Contact USA: | Mr. Roger Barnes, rogerb@cswnet.com |
| Tel. 501 525 86 39 Fax: 501 525 86 12 | |
| Device Proprietary Name: | Fusion7D |
| Common Name of Device: | Multi-modality Registration Workstation Software |
| Classification Name: | Class II: Picture Archiving and Communications System |
| (892 2050) Product Code: LLZ Image Processing System |
Critical Definitions:
| Image Registration | The alignment of one or more [medical] images to a reference image
in order to facilitate geometric comparison. This is a numerical
operation that results in the computation of an explicit mathematical
transformation between every point in the registered image sets. |
|--------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Image Fusion | Registration forms the basis of image fusion in the sense that the
geometrical alignment of images is a prerequisite. The notion of
"fusion" takes this a step further by considering how to visualize the
content of different images representing the same object [organ,
anatomical region, etc.]. Such techniques include the use of overlays,
semi-transparent renderings, etc. |
NOTE: In the context of this application, the term "registration" and "fusion" may be used interchangeably to describe geometric alignment of images and subsequent visualization.
Device description:
Fusion7D is a software program running on a PC platform, which brings into alignment (registers) pairs of images from different imaging modalities. Fusion7D also includes functionality to read, display, and save the original volumetric data and the results of the registration operation by means of a graphic user interface that includes visualization, file browsing and control of input and output as described in the following text.
Registration Engine
Medical images can be divided into anatomical images (e.g. CT and conventional MRI), and functional images (e.g. SPECT and PET). Fusion7D provides two registration solutions: 1. It enables the comparison of pairs of anatomical images (to assess changes in anatomical structures) and 2. It correlates the structures seen in an anatomical dataset with the activity detected in functional images.
1
| Anatomical
to Anatomical | | Anatomical
to Functional | |
|-----------------------------|--------|-----------------------------|--------|
| Source | Target | Source | Target |
| MRI | MRI | MRI | PET |
| MRI | CT | MRI | SPECT |
| CT | CT | CT | PET |
| | | CT | SPECT |
Fusion7D is therefore useful to register the following pairs of datasets:
The registration operation can be a) manual: whereby the user defines the transformation that brings the two datasets into as close alignment as possible, b) semi-automatic: in which the user inputs a series of landmarks in one dataset and the software provides matching landmarks in the other, and c) automatic: in which the software requires no user input and finds the transformation between the two datasets based on the characteristics of the images. In all these cases the transformation is limited to a rigid body deformation (i.e. 3D translation and rotation).
Data/Image Browsing and Visualization
The Fusion7D software incorporates standard visualization facilities to visualize the input DICOM data and the results of the registration operations. This simple visualization GUI includes:
- orthogonal and any-plane slicing of the volumetric data (but no 3D reconstruction), .
- . whole and region of interest zooming,
- panning. .
- . window and level controls,
- image overlays for which the transparency, threshold and colormap is user controlled. ●
The Fusion7D software allows the registration results to be displayed in a variety of ways including: the overlay of one dataset on another, the simultaneous binding of cursors in two volumes and the generation of a split pane image.
Intended Use:
Fusion7D registers pairs of anatomical and functional volumetric images (e.g. MRI-SPECT, MRI-PET, CT-SPECT, CT-PET), or pairs of anatomical volumetric images (e.g. MRI-MRI, CT-CT and MRI-CT) as a means to ease the comparison of image data. The result of the registration operation aims to help the clinician obtain a better understanding of the joint information that would otherwise have to be compared visually. This is useful for a wide range of clinical and therapeutic applications. It is important to note that the clinician retains the ultimate responsibility for making the pertinent diagnosis based on their standard procedures, including visual comparison of the separate unregistered images. Fusion7D is a complement to these standard procedures.
2
Predicate Devices:
| 510(k) No. | Tradename | Manufacturer | Component Applicable to |
|---|---|---|---|
| K010336 | Advantage Windows CT/PET | ||
| Fusion | General | ||
| Electric | Anatomical to Functional | ||
| Registration Component | |||
| K983256 | Advantage Windows Fusion | General | |
| Electric | Anatomical to Anatomical | ||
| Registration Component | |||
| K992654 | Plug 'n View 3D | Voxar | Visualization |
・
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The logo is black and white and appears to be extracted from a document.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 6 2002
Mirada Solutions Ltd. % Mr. Roger W. Barnes Regulatory Consultant 342 Sunset Bay Road HOT SPRINGS AK 71913 Re: K020546
Trade/Device Name: Fusion 7D Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communication system
Regulatory Class: II Product Code: 90 LLZ Dated: February 7, 2002 Received: February 19, 2002
Dear Mr. Barnes:
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 (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); 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.
4
This letter will allow you to begin marketing your device as described in your 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 your device to 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:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html.
Sincerely yours,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
INDICATION FOR USE FORM
· Ver/ 3 - 4/24/96
Applicant: Mirada Solutions Ltd.
Ko20546 510(k) Number (if known):
Device Name: Fusion7D
Indications For Use:
Fusion7D registers pairs of anatomical and functional volumetric images (e.g. MRI-SPECT, MRI-PET, CT-SPECT, CT-PET), or pairs of anatomical volumetric images (e.g. MRI-MRI, CT-CT and MRI-CT) as a means to ease the comparison of image volume data by the clinician. The result of the registration operation aims to help the clinician obtain a better understanding of the joint information that would otherwise have to be compared visually. This is useful for a wide range of clinical and therapeutic applications. It is important to note that the clinician retains the ultimate responsibility for making the pertinent diagnosis based on their standard procedures including visual comparison of the separate unregistered images. Fusion7D is a complement to these standard procedures.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Per 21 CFR 801.109) David L. Swann
(Optional Format 1-2-6)
Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K020546
Prescription Use
Strictly Confidential ms387-0