Universal Stand for Film Changer
by Canon USA, Inc. 510(k)
Active
510(k) K862575
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK862575 | Date14 Jul 1986 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 6 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- KPX
- Device Class
- Class II
- Regulation
- 21 CFR Part 892.1860
- Advisory Committee
- Radiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 28 Sep 2026
A Universal Stand for Film Changer is a device used to support radiographic film changers in radiology settings. It is designed to hold and position film changers for efficient operation during imaging procedures.
The device is supplied as a reusable stand and is regulated under FDA 510(k) clearance K862575. It is classified as a Class II medical device with product code KPX and is intended for use in radiology departments.
Other devices from Canon USA, Inc.
Questions
AI-generated answers, 28 Sep 2026
What is the Universal Stand for Film Changer used for?
The Universal Stand for Film Changer is used to support radiographic film changers in radiology settings, holding and positioning them for efficient operation during imaging procedures.
Is the Universal Stand for Film Changer reusable or single-use?
The device is supplied as a reusable stand, meaning it is designed for repeated use after appropriate cleaning and maintenance in radiology departments.
What regulatory pathway was used for the Universal Stand for Film Changer?
The Universal Stand for Film Changer received FDA 510(k) clearance under K862575, indicating it was found substantially equivalent to a legally marketed predicate device.