# K993959: Isocentric Beam Checker

- Pathway: 510(k) (Traditional)
- Applicant: Mick Radio-Nuclear Instruments, Inc.
- Decided: Feb 14, 2000 after 84 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Med Tec, Inc. Iso-Align: named in the summary without a submission number

## Indications for use
In order to ensure the day to day performance of radiation generating equipment, many quality assurance tests are performed. This testing includes such tests as machine output, beam alignment, distance indicators. In all quality assurance testing a test object or measurement device is used to either validate a system parameter or measure some aspect of system performance. These test objects/devices can easily be classified as one of two types, passive or active. An active device is one that can make a measurement or perform a test without user evaluation or interpretation, while a passive device merely provides an environment or condition for testing, but the result requires the user or operator to make an evaluation and determination. Examples of passive devices are test phantoms or film cassettes. The Mick Radio-Nuclear Isocentric Beam Checker is a passive device, designed to be placed between the incident radiation beam and a piece of film. Radiographic exposure of the Isocentric Beam Checker results in the production of an image on the film which can then be analyzed by the operator for consistency from the prior test exposure. The Isocentric Beam Checker does not alter, change or moderate the radiation field in any manner. It has radio-opaque objects embedded into it that are visualized on standard x-ray film when inserted in a radiation beam. The inspection of the radio-opaque marks on the film is then used in quality assurance.

Source page: https://510kreport.com/device/K993959
Methodology: https://510kreport.com/methodology