Perma-Doc Phantom
by Mick Radio-Nuclear Instruments, Inc.
510(k) K993960
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK993960 | Date14 Feb 2000 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- IYE
- Device Class
- Class II
- Regulation
- 21 CFR Part 892.5050
- Advisory Committee
- Radiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The Perma-Doc Phantom is a quality assurance tool designed for High-Dose-Rate (HDR) brachytherapy systems. It serves as a phantom model for documenting source positioning and stepping accuracy during radiation treatment planning, ensuring compliance with regulatory quality assurance requirements.
This device is used in radiology settings to provide permanent documentation of HDR source positions via film imaging, with a centimeter scale automatically transferred by fluorescent radiation. Supplied as a reusable component, it accommodates up to 20 source positions and includes matching plexiglass plates for film insertion. The Perma-Doc Phantom holds an FDA 510(k) clearance under product code IYE, classified as a Class 2 Radiology device.
Other devices from Mick Radio-Nuclear Instruments, Inc.
Questions
AI-generated answers, 19 Sep 2026
What is the primary purpose of the Perma-Doc Phantom in a clinical setting?
The Perma-Doc Phantom is designed as a quality assurance tool specifically for High-Dose-Rate (HDR) brachytherapy systems. Its main purpose is to provide permanent documentation of source positioning and stepping accuracy during radiation treatment planning, ensuring compliance with regulatory quality assurance requirements. It achieves this by capturing source positions via film imaging, with a built-in centimeter scale automatically transferred through fluorescent radiation.
How many source positions can the Perma-Doc Phantom accommodate, and what components are included for film insertion?
The Perma-Doc Phantom is engineered to accommodate up to 20 source positions. It includes matching plexiglass plates that are used for inserting film, allowing for precise documentation of the source positions during treatment planning.
Is the Perma-Doc Phantom a single-use or reusable device, and how should it be stored?
The Perma-Doc Phantom is supplied as a reusable component, meaning it is designed for repeated use in clinical settings. While the data does not specify storage conditions, reusable medical devices like this typically require proper cleaning, maintenance, and storage in a clean, dry environment to ensure accuracy and longevity.
What regulatory pathway was followed for the FDA clearance of the Perma-Doc Phantom?
The Perma-Doc Phantom received FDA clearance through a 510(k) submission, classified as a Class 2 Radiology device under product code IYE. The clearance was determined to be Substantially Equivalent (SESE) to a predicate device, and the submission was reviewed by the Radiology (RA) Advisory Committee. The decision was made under the traditional 510(k) review process.