Aktina Medicalphysics Corporation Mechanical Frontpointer

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

510(k) Number

K990997 ↗

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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See all devices from Aktina Medical Physics Corp. →

• What is the Aktina Mechanical Frontpointer used for?

  The Aktina Mechanical Frontpointer is used in Medical Physics Quality Assurance to provide a reproducible and accurate mechanism for the setup of test objects and equipment used in quality control and calibrations by medical physicists.

• Is the Aktina Mechanical Frontpointer supplied with a calibration method?

  Yes, the device has a simple calibration method in all three X, Y and Z directions.

• What type of authorization has the Aktina Mechanical Frontpointer received?

  The device has been granted FDA 510K authorization.

• What is the product code of the Aktina Mechanical Frontpointer?

  The product code of the Aktina Mechanical Frontpointer is IYE.