← Product Code [IYE](/submissions/RA/subpart-f%E2%80%94therapeutic-devices/IYE) · K955774 # VARIS PORTALVISION (K955774) _Varian Assoc., Inc. · IYE · Mar 15, 1996 · Radiology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/IYE/K955774 ## Device Facts - **Applicant:** Varian Assoc., Inc. - **Product Code:** [IYE](/submissions/RA/subpart-f%E2%80%94therapeutic-devices/IYE.md) - **Decision Date:** Mar 15, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 892.5050 - **Device Class:** Class 2 - **Review Panel:** Radiology ## Indications for Use To assist the therapist in verification of the treatment field and shielding blocks in relation to anatomical landmarks in radiotherapy treatment. ## Device Story VARiS PortalVision™; on-line electronic portal imaging system for radiotherapy verification. Input: radiation signals via ionization chamber. Processing: image acquisition, processing, and evaluation via VARiS Images application subsystem. Output: verified treatment field images, matched sets, batch matching, scatter plots. Used in clinical radiotherapy settings; operated by therapists. Healthcare providers use quantitative comparison tools to verify shielding blocks and treatment fields against anatomical landmarks; facilitates precise radiation delivery; improves treatment accuracy. ## Clinical Evidence Bench testing only. No clinical data provided. ## Technological Characteristics Ionization chamber imaging sensor. Platform: Intel Pentium-based PC. OS: Microsoft Windows NT or Windows 95. Software: VARiS Images application subsystem. Features: image acquisition, processing, quantitative comparison tools, batch matching, scatter plots, off-line double exposure, multiple combined images, export/import functionality. ## Regulatory 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. ## Predicate Devices - Varian Electronic Portal Imaging System 'PortalVision™' (K901932B) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} MAR 15 1996 K955774 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} K1SS774 5. Intended Use: To assist the therapist in verification of the treatment field and shielding blocks in relation to anatomical landmarks in radiotherapy treatment. 6. Technological Considerations: VARiS PortalVision™ is Windows based and menu driven. The predicate electronic portal imaging 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. --- **Source:** [https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/IYE/K955774](https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/IYE/K955774) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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