Canon X-Ray Film Changer CFC-U1
by Canon USA, Inc. 510(k)
Active
510(k) K851067
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK851067 | Date21 May 1985 | 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- Withdrawn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, 19 Sep 2026
The Canon X-Ray Film Changer CFC-U1 is a radiographic film/cassette changer, classified under the nomenclature authority as a device intended for use in radiologic procedures. It is designed to automate the positioning and movement of radiographic film or cassettes during X-ray exposures, improving workflow efficiency in radiology settings.
This device is supplied as a reusable Class II medical device, subject to traditional 510(k) clearance under FDA regulation 892.1860. It is intended for use in radiology departments and must be handled in accordance with standard radiographic safety protocols. The CFC-U1 was cleared by the FDA in 1985 under the K-number K851067 and remains compliant with special controls for radiographic film/cassette changers.
Other devices from Canon USA, Inc.
Questions
AI-generated answers, 19 Sep 2026
What is the Canon X-Ray Film Changer CFC-U1 used for?
The Canon X-Ray Film Changer CFC-U1 is designed to automate the positioning and movement of radiographic film or cassettes during X-ray exposures, improving workflow efficiency in radiology settings as part of radiographic procedures.
Is the Canon X-Ray Film Changer CFC-U1 a single-use or reusable device?
The Canon X-Ray Film Changer CFC-U1 is supplied as a reusable medical device, meaning it is intended for multiple uses after proper cleaning and maintenance in accordance with standard radiographic safety protocols.
What regulatory pathway was used for the Canon X-Ray Film Changer CFC-U1?
The Canon X-Ray Film Changer CFC-U1 received traditional 510(k) clearance from the FDA, demonstrating substantial equivalence to a predicate device under regulation 892.1860 for radiographic film/cassette changers.
When was the Canon X-Ray Film Changer CFC-U1 cleared by the FDA?
The Canon X-Ray Film Changer CFC-U1 was cleared by the FDA on May 21, 1985, under the K-number K851067, following submission on March 18, 1985.
What classification does the Canon X-Ray Film Changer CFC-U1 hold under FDA regulations?
The Canon X-Ray Film Changer CFC-U1 is classified as a Class II medical device by the FDA, subject to special controls for radiographic film/cassette changers under regulation 892.1860.