# K993960: Perma-Doc Phantom

- 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 medical devices, many quality assurance tests are performed. In all quality assurance testing a phantom 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 direct 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 Perma-Doc Phantom is an example of a passive device. It is designed to be placed between the source from a HDR system and a piece of film. Radiographic exposure of the film by the HDR source 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 Perma-Doc Phantom does not alter, change or moderate the radiation field in any manner. It has a radio-opaque scale embedded into it that can be visualized on standard x-ray film when exposed to the radiation output from the HDR system. Inspection of the image on the film is then used as part of the quality assurance process.

Source page: https://510kreport.com/device/K993960
Methodology: https://510kreport.com/methodology