# K990997: Aktina Medicalphysics Corporation Mechanical Frontpointer

- Pathway: 510(k) (Traditional)
- Applicant: Aktina Medical Physics Corp.
- Decided: Jun 22, 1999 after 89 days
- Product code: IYE (Accelerator, Linear, Medical)
- Device class: 2
- Regulation: 21 CFR 892.5050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K874558 (1988). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K874558: SL Series, SL 15, 18, 20 & 25, Philips Medical Systems, Inc. (1988) Summary page 1.
- (no number) Sears Tape Measure: named in the summary without a submission number

## Indications for use
In Radiation Therapy and Diagnostic Radiology, an ongoing quality assurance program is essential for ensuring the overall quality of patient care. As part of the overall quality assurance program daily, monthly and annual tests to validate machine output, field size indicators, and general machine geometry are performed. In order to obtain reproducible results, these tests must be performed under the same conditions, with the same physical parameters. Since machine output and field size are directly rclated to the geometry of the test conditions it is important that the distance from the beam source to the test device is consistent. The Aklina Medical Physics Corporation Mechanical Frontpointer is designed to provide this ability. By utilizing the fixed geometry of the accessory mount system on a linear accelerator, a rigid based for measuring distance can be obtained. The Mechanical Frontpointer presented in this notification functions exactly as a standard mechanical tape measure however by being attached to a frame which slides into the accessory mount a reproducible setup is ensured.

Source page: https://510kreport.com/device/K990997
Methodology: https://510kreport.com/methodology