Dynatrac, Cod. 50-1A

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

510(k) Number

K034051 ↗

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 clinical applications is the Dynatrac, Cod. 50-1A, primarily used for in a medical setting?

  The Dynatrac, Cod. 50-1A is designed to generate high-energy x-rays for radiation therapy and diagnostic radiology procedures. It produces controlled radiation beams to support precise medical applications, such as targeted cancer treatment and detailed imaging, within radiology departments.

• Is the Dynatrac, Cod. 50-1A, a single-use device or intended for reuse in clinical environments?

  The Dynatrac is supplied as a reusable system, meaning it is engineered for repeated use in clinical settings. Proper maintenance and adherence to the manufacturer’s guidelines are required to ensure safe and effective operation over time.

• What regulatory pathway was followed for the FDA clearance of the Dynatrac, Cod. 50-1A?

  The Dynatrac received FDA clearance through a 510(k) premarket notification process, classified under 21 CFR 892.5050 as a Class II medical device. The submission was reviewed by the Radiology (RA) Advisory Committee and determined to be substantially equivalent to a predicate device, allowing it to enter the market under traditional clearance.

• How is the Dynatrac, Cod. 50-1A, categorized in terms of medical specialty usage?

  The device is explicitly governed by radiology specialty requirements, as indicated in its regulatory filings. It is designed for use in radiology departments where high-energy x-ray generation is essential for therapeutic and diagnostic applications.

• What type of maintenance or operational considerations should be taken into account when using the Dynatrac?

  Since the Dynatrac is a reusable linear medical accelerator, it requires regular maintenance and adherence to manufacturer guidelines to ensure safety, performance, and compliance with regulatory standards for medical charge-particle radiation. Proper training for operators is also implied due to its specialized function.