Aktina Medical Physics Corporation Photon Beam Blocking System

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

510(k) Number

K974239 ↗

FDA Product Code

IXI

Device Class

Class II

Regulation

21 CFR Part 892.5710

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

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See all devices from Aktina Medical Physics Corp. →

• What is the Aktina Medical Physics Corporation Photon Beam Blocking System used for?

  The Aktina Photon Beam Blocking System is a tertiary beam block used in radiation therapy to further collimate and contour treatment fields, creating irregularly shaped fields that match specific treatment areas for more precise radiation delivery.

• What is included in the Low Energy Lead Block Kit?

  The kit includes 14 pre-shaped clinical lead blocks designed for photon energies greater than 6MV. Each block is 8 cm thick as specified by NCRP Report No. 102, with surfaces covered in white powder-coat paint for durability and visibility.

• Is the Aktina Photon Beam Blocking System single-use or reusable?

  The Aktina Photon Beam Blocking System is designed for reuse in clinical settings. It is a physical accessory to radiation equipment that can be repeatedly used to shape treatment fields according to patient-specific requirements.

• What regulatory status does the Aktina Photon Beam Blocking System have?

  The device is regulated under FDA 510(k) clearance with K number K974239 and is classified as Block, Beam-shaping, Radiation Therapy (product code IXI). It has been determined to be substantially equivalent to predicate devices.