ExacTrac Dynamic 1.1.2
FDA 510(k)Class II (US FDA 510(k))
by Brainlab AG
Identifiers
- 510(k) Number
- K231052 FDA 510(k)
- FDA Product Code
- IYE FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.5050 FDA 510(k)
- Regulation Number
- 892.5050 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The ExacTrac Dynamic 1.1.2 is a medical device classified as an Accelerator, Linear, Medical, used in the field of Radiology. It is designed for image-guided radiation therapy delivery and patient positioning in radiation oncology, supporting precise targeting during treatment procedures.
The device is supplied as a reusable system and has received FDA 510(k) clearance under K231052, with a determination of Substantially Equivalent. It is manufactured by Brainlab AG in Munich, Germany, and is intended for use in clinical settings requiring radiation therapy guidance and monitoring.
Frequently asked questions
What is the ExacTrac Dynamic 1.1.2 used for?
The ExacTrac Dynamic 1.1.2 is designed for image-guided radiation therapy delivery and patient positioning in radiation oncology, supporting precise targeting during treatment procedures to improve accuracy in radiation treatment.
Is the ExacTracTrac Dynamic 1.1.2 reusable or single-use?
The ExacTrac Dynamic 1.1.2 is supplied as a reusable system, meaning it is intended for multiple uses in clinical settings after appropriate cleaning and maintenance, not for single-use disposal.
What regulatory clearance does the ExacTrac Dynamic 1.1.2 have?
The ExacTrac Dynamic 1.1.2 has received FDA 510(k) clearance under submission number K231052, with a determination of Substantially Equivalent, allowing it to be marketed for its intended use in radiation therapy guidance and monitoring.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K231052 | Class II | Active |
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Manufacturer
- Manufacturer
- Brainlab AG
Sources (1)
- FDA 510(k) K231052 24 fields · synced Sep 23, 2026