Brainlab Linac Hardware
by Brainlab Med. Computersysteme GmbH 510(k)
Active
510(k) K934657
Overview
The Brainlab Linac Hardware is a Linear Accelerator, Medical, designed for radiation therapy. It delivers high-energy X-ray beams used in external beam radiotherapy to treat malignant and benign conditions, including cancers of the brain, body, and other tissues. This hardware integrates with radiation treatment planning systems to ensure precise dose delivery and alignment with patient anatomy, supporting modalities such as stereotactic radiosurgery and intensity-modulated radiation therapy (IMRT).
This device is supplied as part of a comprehensive radiation oncology system and is intended for use in sterile or controlled clinical environments, such as radiation therapy departments in hospitals or specialized centers. It is classified as a Class II (Special Controls) device under FDA regulations (892.5050) and has received FDA 510(k) clearance through the Traditional pathway. The hardware is non-disposable and requires maintenance, calibration, and periodic servicing as specified by the manufacturer. MRI safety considerations apply as outlined in the device documentation, and usage adheres to regulatory guidelines for radiation safety and quality assurance.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK934657 | Date22 Jul 1994 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- IYE
- Device Class
- Class II
- Regulation
- 21 CFR Part 892.5050
- Advisory Committee
- Radiology
- FDA Decision
- SESE Substantially Equivalent
Other devices from Brainlab Med. Computersysteme GmbH
Questions
What is the Brainlab Linac Hardware used for?
The Brainlab Linac Hardware is a medical linear accelerator designed specifically for radiation therapy. It generates high-energy X-ray beams used in external beam radiotherapy to treat malignant and benign conditions, including cancers of the brain, body, and other tissues. This hardware supports advanced radiotherapy techniques such as stereotactic radiosurgery and intensity-modulated radiation therapy (IMRT), ensuring precise dose delivery aligned with patient anatomy.
How is the Brainlab Linac Hardware supplied and where is it used?
The Brainlab Linac Hardware is supplied as part of a comprehensive radiation oncology system. It is intended for use in controlled clinical environments, such as radiation therapy departments within hospitals or specialized centers. The device operates in sterile or controlled settings to ensure patient safety and treatment accuracy.
Is the Brainlab Linac Hardware single-use or reusable?
The Brainlab Linac Hardware is a non-disposable device. It requires regular maintenance, calibration, and periodic servicing as outlined by the manufacturer to ensure optimal performance and safety. This includes adherence to manufacturer guidelines for upkeep and regulatory standards for radiation safety.
What regulatory pathway was followed for the Brainlab Linac Hardware?
The Brainlab Linac Hardware received FDA 510(k) clearance through the Traditional pathway. It is classified as a Class II (Special Controls) device under FDA regulations (892.5050), indicating it has undergone a review process to demonstrate substantial equivalence to a predicate device. This classification ensures it meets specific performance and safety standards for medical linear accelerators.
Are there any special considerations for MRI safety with the Brainlab Linac Hardware?
Yes, MRI safety considerations apply to the Brainlab Linac Hardware. The device documentation includes guidelines to ensure safe operation in environments where MRI equipment is present. These guidelines help prevent interference and ensure patient safety during combined radiation and MRI procedures, if applicable.