SRS-200 Radiosurgery System

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K891292 ↗

FDA Product Code

IYE

Device Class

Class II

Regulation

21 CFR Part 892.5050

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

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• What types of medical facilities are the SRS-200 Radiosurgery System intended for, and what is its primary purpose within those settings?

  The SRS-200 Radiosurgery System is designed for use in radiology departments and radiation oncology clinics. Its primary purpose is to deliver precise, non-invasive radiosurgery treatments, which involve targeting high-dose radiation to specific tissues—such as brain tumors or vascular malformations—while minimizing exposure to surrounding healthy areas. This makes it a specialized tool for conditions requiring highly accurate radiation delivery.

• Is the SRS-200 Radiosurgery System reusable or single-use, and what does this mean for maintenance and operational workflows?

  The SRS-200 Radiosurgery System is a reusable medical device, meaning it is not intended for single-use. This implies that it requires regular installation, calibration, and maintenance to ensure accurate and safe operation over time. Facilities must establish protocols for cleaning, servicing, and quality checks to uphold performance standards.

• How is the SRS-200 Radiosurgery System regulated, and what does this mean for purchasing or implementing it in a clinic?

  The SRS-200 Radiosurgery System is regulated under the FDA’s 510(k) clearance process, specifically with clearance number K891292, and is classified as a Class II device under product code IYE. This means it has undergone a premarket submission to demonstrate substantial equivalence to a predicate device and must comply with FDA requirements for safety and effectiveness. Purchasers should verify compliance with FDA guidelines and ensure proper installation and training.

• Does the SRS-200 Radiosurgery System come with specific sterility requirements, or is it designed for non-sterile environments?

  The SRS-200 Radiosurgery System does not have specific sterility requirements noted in its regulatory data, as it is a reusable device intended for controlled environments like radiology departments or radiation oncology clinics. However, proper cleaning and maintenance protocols must be followed to prevent contamination and ensure safe operation.

• What kind of precision does the SRS-200 Radiosurgery System offer, and how does this benefit patients undergoing radiosurgery?

  The SRS-200 Radiosurgery System is designed with an isocentric subsystem to achieve sub-millimeter mechanical accuracy, ensuring highly precise radiation delivery. This level of precision is critical for targeting small or delicate areas, such as brain tumors or vascular malformations, while sparing adjacent healthy tissue. This accuracy improves treatment outcomes and reduces potential side effects for patients.