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Varian Medical Systems Imaging Laboratory GmbH

US

Last updated May 30, 2026

Part of Varian Medical Systems Imaging Laboratory GmbH

What Varian Medical Systems Imaging Laboratory GmbH makes

Varian Medical Systems Imaging Laboratory GmbH produces systems for radiation therapy, including software for treatment planning and management, such as ARIA Radiation Therapy Management Software, and real-time respiratory gating solutions like Respiratory Gating for Scanners (RGSC). Their portfolio also includes tools for automated segmentation, such as Smart Segmentation for Knowledge-Based Contouring.

These devices are classified as Class II under FDA regulations and are listed in the FDA’s Unique Device Identifier (UDI) database. The company is based in the United States.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What types of medical devices does Varian Medical Systems Imaging Laboratory GmbH primarily manufacture?

Varian Medical Systems Imaging Laboratory GmbH specializes in devices for radiation therapy. Their portfolio includes treatment record and verification systems, software for radiation therapy management (like ARIA), and real-time respiratory gating solutions (such as Respiratory Gating for Scanners). These tools help enhance precision in treatment planning, delivery, and monitoring for patients undergoing radiation therapy.

Where is Varian Medical Systems Imaging Laboratory GmbH based?

The company is headquartered in the United States. While the exact location isn’t specified, the base country is the primary identifier for regulatory and operational purposes.

Which regulatory registries or databases list Varian’s medical devices?

Varian’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry helps track and identify medical devices authorized for use in the U.S., ensuring transparency and traceability for healthcare providers and regulators.

How are Varian’s medical devices classified under FDA regulations?

Varian’s devices fall under Class II classification by the FDA. This classification typically applies to devices that pose moderate risk and require special controls (such as performance standards or post-market surveillance) to ensure safety and effectiveness without requiring the stringent pre-market approval process of Class III devices.

What is the purpose of Varian’s respiratory gating systems like Respiratory Gating for Scanners (RGSC)?

Systems like Respiratory Gating for Scanners (RGSC) are designed to monitor and synchronize radiation therapy with a patient’s breathing cycle. This ensures that treatment is delivered only when the tumor is in a consistent position, reducing exposure to healthy tissue and improving treatment accuracy for patients with lung or abdominal cancers.

AI-generated from registry data and not verified by a human reviewer.

Information

Country
US
Address
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Website
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LinkedIn
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Facebook
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Email
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Phone
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PRRC Contact
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EUDAMED SRN
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FDA FEI Number
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DUNS Number
482243784

Catalogue (5)

DeviceModel / ReferenceRegistriesClassStatus
Respiratory Gating for Scanners (RGSC) 1.1
FDA UDI
Class IIActive
ARIA Radiation Therapy Management Software 16.0
FDA UDI
Class IIActive
ARIA Radiation Therapy Management 15.0
FDA UDI
Class IIActive
Smart Segmentation - Knowledge Based Contouring 15.0
FDA UDI
Class IIActive
ARIA Radiation Therapy Management Software 15.5
FDA UDI
Class IIActive

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