(28 days)
Not Found
No
The description focuses on traditional image registration techniques like bone or intensity matching and landmark alignment, with no mention of AI, ML, or related concepts.
No
The device is a pre-processing registration tool that aids in the identification of brain tumors prior to radiotherapy or stereotactic neurosurgical treatment planning. It does not directly provide therapy.
No.
The device is described as a "pre-processing registration tool" and "image registration software" that aids in the identification of brain tumors prior to treatment planning. It does not provide a diagnosis itself but rather prepares images for use with other systems that perform diagnostic or treatment planning functions.
Yes
The device description explicitly states "ImageFusion 2.0 is image registration software" and describes its function as processing and fusing existing image sets, without mentioning any associated 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:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states that this device is "image registration software for fusing a pair of 3D image sets" (CT and MR images). It processes medical images acquired from the patient's body, not samples taken from the body.
- Intended Use: The intended use is for "pre-processing registration tool for use with other stereotactic surgical and neurosurgical treatment planning systems." This is a tool for image manipulation and preparation for surgical planning, not for diagnostic testing of biological samples.
Therefore, this device falls under the category of medical image processing software, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
A pre-processing registration tool for use with other stereotactic surgical and neurosurgical treatment planning systems.
Product codes (comma separated list FDA assigned to the subject device)
90 MUJ
Device Description
ImageFusion 2.0, aids in identification of brain tumors prior to radiotherapy or stereotactic neurosurgical treatment planning. ImageFusion 2.0 has been enhanced to allow fusion of MR/MR images, in addition to CT/CT and CT/MR fusions that the previous version was capable of performing. The fusion process is based on the matching of bone or intensity and does not rely on matching of stereotactic rods or image slices. Therefore, a non-stereotactic MR or CT image can be re-sampled according to the stereotactic coordinates of the reference CT or MR image and further used in a stereotactic capacity.
ImageFusion 2.0 is image registration software for fusing a pair of 3D image sets. Both the reference and secondary image sets can be CT or MR images. The MR scans can be T1-weighted or non T1-weighted.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
MR, CT
Anatomical Site
brain
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Radionics Software Applications' ImageFusion 2.0 system testing verifies that the registration of MR images in stereotactic CT space is accurate and is approximately 1.7 mm on average and 2.9 mm maximum for individual landmarks. Further, system and unit testing verify that features such as bone segmentation, intensity match and landmark alignment, which form the basis of a fusion session, are accurate.
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
§ 892.5050 Medical charged-particle radiation therapy system.
(a)
Identification. A medical charged-particle radiation therapy system is a device that produces by acceleration high energy charged particles (e.g., electrons and protons) intended for use in radiation therapy. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.(b)
Classification. Class II. When intended for use as a quality control system, the film dosimetry system (film scanning system) included as an accessory to the device described in paragraph (a) of this section, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
0
K990071
ImageFusion 2.0 - 510(k) Summary
This Summary of the 510(k) safety and effectiveness information is submitted in accordance with the requirements of the Safe Medical Devices Act of 1990 and 21 CFR 8807.92.
Submitter of Premarket Notification:
Nancy MacDonald Sr. Regulatory Engineer Radionics Software Applications, Inc. 22 Terry Ave. Burlington, MA 01803 Telephone: (781) 272-1233, ext. 296 Fax: (781) 272-2428
Establishment Registration Number: 1222895
Performance Standards: None established under Section 514.
This summary was prepared on January 6, 1999.
Device Name: ImageFusion 2.0
Common Name: Image Correlation System
Safety Summary:
Radionics Software Applications' ImageFusion 2.0 system testing verifies that the registration of MR images in stereotactic CT space is accurate and is approximately 1.7 mm on average and 2.9 mm maximum for individual landmarks. Further, system and unit testing verify that features such as bone segmentation, intensity match and landmark alignment, which form the basis of a fusion session, are accurate.
Predicate Device:
ImageFusion System: 510(k) number K960071, dated April 17, 1996.
Intended Use:
The intended use for ImageFusion 2.0 is: A pre-processing registration tool for use with other stereotactic surgical and neurosurgical treatment planning systems.
1
ImageFusion 2.0 510(k) Summary _ cont.
Device Description:
ImageFusion 2.0, aids in identification of brain tumors prior to radiotherapy or stereotactic neurosurgical treatment planning. ImageFusion 2.0 has been enhanced to allow fusion of MR/MR images, in addition to CT/CT and CT/MR fusions that the previous version was capable of performing. The fusion process is based on the matching of bone or intensity and does not rely on matching of stereotactic rods or image slices. Therefore, a non-stereotactic MR or CT image can be re-sampled according to the stereotactic coordinates of the reference CT or MR image and further used in a stereotactic capacity.
ImageFusion 2.0 is image registration software for fusing a pair of 3D image sets. Both the reference and secondary image sets can be CT or MR images. The MR scans can be T1-weighted or non T1-weighted.
2
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The bird is oriented towards the upper right. Encircling the bird is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
8 1999 FEB
Nancy C. MacDonald Senior Regulatory Engineer Radionics Software Applications, Inc. 22 Terry Avenue Burlington, MA 01803-2516
Re:
ImageFusion 2.0 Dated: January 8, 1999 Received: January 11, 1999 Regulatory class; II 21 CFR 892.5050/Procode: 90 MUJ
Dear Ms. MacDonald:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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 manteed production as now the energes that have been reciassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). 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 III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of be dayse to outlieral controlly Extrans. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. 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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,
Capt. Daniel G. Schultz, M.D.
Acting Director, Division of Reproductive,
Abdominal, Ear, Nose and Throat,
and Radiological Devices
Office of Device Evaluation
Center for Devices and
Radiological Health
Enclosure
3
510(k) Number (if known):
Device Name: ImageFusion 2.0
Indications for use:
A pre-processing registration tool for use with other stereotactic surgical and neurosurgical treatment planning systems.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109
OR
Over-The-Counter Use __
(Optional Format 1-2-96)
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number K990071