(81 days)
No
The document describes a hardware CT acquisition system and image manipulation capabilities, but there is no mention of AI, ML, or related concepts like deep learning or neural networks. The "automatically marked on the fluoro image" feature is likely a rule-based or algorithmic process, not necessarily AI/ML.
No
The device is described as an attachment used to obtain CT images for radiation therapy treatment planning, indicating its role in diagnosis and planning, not direct therapy.
No
The device is used to obtain CT images for radiation therapy treatment planning, which is a part of treatment delivery, not disease diagnosis.
No
The device description explicitly states that the Varian Ximatron ScanVision is a "hardware computed tomography acquisition system" and an "attachment" to the Ximatron simulator, indicating it includes physical components beyond just software.
Based on the provided information, the Varian Ximatron ScanVision CT 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 Varian Ximatron ScanVision is a CT imaging device used to obtain images of the patient's body in vivo (within the living body) for radiation therapy planning. It does not analyze samples taken from the patient.
- Intended Use: The intended use is clearly stated as obtaining CT images for radiation therapy treatment planning, which is an in vivo imaging application.
Therefore, the Varian Ximatron ScanVision falls under the category of medical imaging devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The purpose of the Ximatron ScanVision is to be used to obtain CT images of the patient in the intended treatment position. for the purpose of radiation therapy treatment planning.
The Varian Ximatron ScanVision CT device is an attachment to the Varian Radiation therapy simulator Ximatron. It is to be used to obtain CT images of the patient in the intended treatment position, for the purposes of radiation therapy treatment planning.
Product codes
90 KPR
Device Description
The Varian Ximatron ScanVision is an attachment to the Varian Radiation therapy simulator Ximatron. ScanVision is a hardware computed tomography acquisition system, based on Varian Ximiatron radiation therapy simulator. It acquires CT silce Infornation as digital images from the Ximatron simulator. These images may be viewed and manipulated prior to being made available to the doctor for planning the treatment.
In combination with XimaVision, which is an integral part of ScanVision, either:
- the doctor can specify and mark on the flattened fluoro image where he wants the slices to be taken . or
- t after the slices have been taken, the slice positions can be automatically marked on the fluoro image.
ScanVision is also linked to the Ximitron for automatic set-up of the Ximatron and the X-ray generator for scanning.
Mentions image processing
Acquires CT silce Infornation as digital images from the Ximatron simulator. These images may be viewed and manipulated prior to being made available to the doctor for planning the treatment.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT images
Anatomical Site
Not Found
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)
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
§ 892.1680 Stationary x-ray system.
(a)
Identification. A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
0
JUN 67 198 888 888:29PM MaxIHS UH JUN 1 2 1998
981056
varian@
oncology systems
Premarket Notification [510K] Summary as required by 21 CFR 807.92
Date Summary was prepared: March 18, 1998
Submitter's Name;
Varian Oncology Systems 3045 Hanover Street Palo Alto, CA 94304
Contact Person:
Linda S Nash Regulatory Compliance & Safety Manager Phone (650) 424-6990 FAX (650) 424-4830 E-Mail linda.nash@os.varian.com
Device Name:
Varian Ximatron ScanVision with Version 5.0 Software
Classification Name;
Radiation Therapy Simulation System
Predicate Device:
Varian Ximatron CT Option cleared to market per 510(k) No. K910647
Product Description:
The Varian Ximatron ScanVision is an attachment to the Varian Radiation therapy simulator Ximatron. ScanVision is a hardware computed tomography acquisition system, based on Varian Ximiatron radiation therapy simulator. It acquires CT silce Infornation as digital images from the Ximatron simulator. These images may be viewed and manipulated prior to being made available to the doctor for planning the treatment.
In combination with XimaVision, which is an integral part of ScanVision, either:
- the doctor can specify and mark on the flattened fluoro image where he wants the slices to be taken . or
- t after the slices have been taken, the slice positions can be automatically marked on the fluoro image.
ScanVision is also linked to the Ximitron for automatic set-up of the Ximatron and the X-ray generator for scanning.
Intended Use:
The purpose of the Ximatron ScanVision is to be used to obtain CT images of the patient in the intended treatment position. for the purpose of radiation therapy treatment planning.
Image /page/0/Picture/24 description: The image shows a logo with the words "PARTNERS FOR LIFE" stacked on top of each other. The word "PARTNERS" is in a bold, sans-serif font, while the words "FOR LIFE" are in a cursive font. The logo is in black and white.
In printact on necveded noon
1
Image /page/1/Picture/0 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle design, with three curved lines forming the body and wings. The eagle is enclosed within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper half of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 2 1998
Linda S. Nash Regulatory Compliance & Safety Manager Varian Oncology Systems 3045 Hanover Street Palo Alto, CA 94304
Re:
K981056 Ximatron Scan Vision Dated: March 18, 1998 Received: March 23, 1998 Regulatory class: II 21 CFR 892.5840/Procode 90 KPR
Dear Ms. Nash:
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 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 Feseral 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 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 895. 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 (2) 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 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 vitto 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/odri/dsmaldsmam.html".
Sincerely yours,
William Yin
Lillian Yin, Ph.D. Director, Division of Reproductive Abdominal, Ear, Nose and Throa and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Image /page/2/Picture/0 description: The image shows the word "varian" in a bold, sans-serif font. To the right of the word is a circular logo with a stylized "W" inside. The logo is simple and modern, and the overall design is clean and professional. The text and logo are both in black.
Statement of Indications for Use*
I state in my capacity as Manager, Regulatory Compliance and Safety, of Varian Oncology r state in the Product which is the subject of this premarket notification is intended to be used for the following:
The Varian Ximatron ScanVision CT device is an attachment to the Varian Radiation therapy simulator Ximatron. It is to be used to obtain CT images of the patient in the intended treatment position, for the purposes of radiation therapy treatment planning.
Js Nash
Linda S Nash
Linda & Nash. Regulatory Compliance & Safety Manager
March 18, 1998 Date
*Suggested language and format to meet the requirements of section 513(i) of the Federal Food, Drug, and Cosmetic Act, as amended, and 21 CFR sections 801.4 and 809.92(a)(5).
981056
510(k) Number
Windle Bergman
(Division Sign-Off)
oductive, Abdominal, El
Division Sign-off Office of Device Evaluation
Prescription Use (Per 21 CFR 801.109)
over-the-counter Use