(85 days)
K901932B
K901932B
No
The description mentions "image processing" and "quantitative comparison tools" but does not use terms like AI, ML, deep learning, or neural networks, nor does it describe functionalities typically associated with AI/ML in medical imaging (e.g., automated detection, segmentation, or prediction based on learned patterns). The technology described appears to be based on traditional image processing and comparison techniques.
No.
The device is used for verification and imaging in radiotherapy treatment, not for providing therapy itself.
No
The device is described as an "on-line electronic portal imaging system" used for "verification of the treatment field and shielding blocks in relation to anatomical landmarks in radiotherapy treatment." This indicates its role in treatment delivery and quality assurance, not in diagnosing disease or medical conditions.
No
The device description explicitly states that the imaging mechanism is an ionization chamber, which is a hardware component. While the system includes software for image processing and evaluation, it is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "assist the therapist in verification of the treatment field and shielding blocks in relation to anatomical landmarks in radiotherapy treatment." This is a therapeutic application, specifically related to ensuring accurate delivery of radiation therapy.
- Device Description: The device is an "on-line electronic portal imaging system" that uses an ionization chamber to acquire images for verification during radiotherapy. This is a medical imaging device used for treatment guidance.
- Lack of IVD Characteristics: An IVD is a medical device intended for use in vitro (outside the body) for the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not examine specimens from the body; it images the patient's anatomy and the radiation field in vivo (within the body) during treatment.
Therefore, the VARiS PortalVision™ is a medical device used in radiotherapy, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
To assist the therapist in verification of the treatment field and shielding blocks in relation to anatomical landmarks in radiotherapy treatment.
Product codes
Not Found
Device Description
VARiS PortalVision™ is an on-line electronic portal imaging system which allows for verification of the treatment field and shielding blocks in relation to anatomical landmarks in radiotherapy treatment. The imaging mechanism of VARiS PortalVision™ is an ionization chamber. VARiS PortalVision™ is fully integrated into Varian's VARiS environment. It is a subsystem of the VARiS Images application. The VARiS PortalVision™ software supports image acquisition, image processing, and image evaluation by means of quantitative comparison tools. As a subsystem of VARiS Images, VARiS Portal Vision™ runs on the VARiS Images workstation. The VARiS Images workstation is based on an Intel Pentium processor based PC running Microsoft Windows NT or the Win 95 operating system.
Mentions image processing
image processing
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Portal imaging / Ionization chamber
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
therapist
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)
K901932B
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
MAR | 5 |996 |
.
SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION
| 1. Submitter: | Varian Oncology Systems
3045 Hanover Street
Palo Alto, CA 94304 |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Charles H. Will, Manager
Regulatory Compliance & Safety
Phone: (415) 424-5036
FAX: (415) 424-4830 |
| Prepared: | December 22, 1995 |
| 2. Device Name: | VARiS PortalVision™ |
| 3. Predicate Device: | Varian Electronic Portal Imaging
System "PortalVision™"
510 Notification K901932B
Cleared May 3, 1991 |
| 4. Description: | VARiS PortalVision™ is an on-line electronic portal
imaging system which allows for verification of the
treatment field and shielding blocks in relation to
anatomical landmarks in radiotherapy treatment. The
imaging mechanism of VARiS PortalVision™ is an
ionization chamber.
VARiS PortalVision™ is fully integrated into Varian's
VARiS environment. It is a subsystem of the VARiS
Images application. The VARiS PortalVision™
software supports image acquisition, image
processing, and image evaluation by means of
quantitative comparison tools.
As a subsystem of VARiS Images, VARiS Portal
Vision™ runs on the VARiS Images workstation.
The VARiS Images workstation is based on an Intel
Pentium processor based PC running Microsoft
Windows NT or the Win 95 operating system. |
1
5774
- To assist the therapist in verification of the treatment Intended Use: 5. field and shielding blocks in relation to anatomical landmarks in radiotherapy treatment.
- VARiS PortalVision™ is Windows based and menu 6. Technological driven. The predicate electronic portal imaging Considerations: system is character oriented and menu driven. The predicate portal imaging device provides matched sets whereas VARiS PortalVision™ provides matched sets, batch matching and scattered plots. Both of these systems provide off-line double exposure, multiple combined images and export/import functionality.