Bcm-600 Mini-Six Extra Lg. Field Angio
by B C Medical, Ltd. 510(k)
Active
510(k) K801950
Overview
The BCM-600 Mini-Six Extra Large Field Angio is a Changer, Radiographic Film/Cassette (OpenFDA classification: KPX, Regulation 892.1860) designed for radiology applications. It is a film changer system used in angiographic imaging to automate the loading and unloading of radiographic film cassettes, improving workflow efficiency during fluoroscopic procedures.
This device is supplied as a reusable Class II medical device, intended for use in radiology settings. It requires proper maintenance and cleaning to ensure optimal performance and sterility where applicable. The BCM-600 Mini-Six Extra Large Field Angio holds an FDA 510(k) clearance (K801950) with a decision dated October 3, 1980, classified under the Radiology advisory committee. No additional sterility or MRI safety specifications are noted in the available data.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK801950 | Date3 Oct 1980 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- 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
- FDA applicant
- B C Medical , Ltd.
- Device Class
- Class II
- Regulation
- 21 CFR Part 892.1860
- Advisory Committee
- Radiology
- FDA Decision
- SESE Substantially Equivalent
Other devices from B C Medical, Ltd.
Questions
What is the BCM-600 Mini-Six Extra Large Field Angio used for in a clinical setting?
The BCM-600 Mini-Six Extra Large Field Angio is a radiographic film changer system designed to automate the loading and unloading of film cassettes during angiographic imaging. It improves workflow efficiency in fluoroscopic procedures by reducing manual handling of cassettes, which is particularly useful in radiology departments performing vascular imaging studies.
Is the BCM-600 Mini-Six Extra Large Field Angio a single-use or reusable device?
This device is reusable, classified as a Class II medical device. Since it is not sterile by design, proper maintenance and cleaning are required to ensure reliable performance and hygiene in clinical use. Sterility is not a standard feature for this type of film changer system.
How was the BCM-600 Mini-Six Extra Large Field Angio approved by the FDA?
The device received FDA 510(k) clearance (K801950) under the Traditional 510(k) review pathway, determined to be substantially equivalent to a legally marketed predicate. The clearance was issued on October 3, 1980, following review by the Radiology Advisory Committee (RA). This classification reflects its role as a radiographic film/cassette changer for angiographic imaging.
What type of radiology procedures is this device intended for?
The BCM-600 Mini-Six Extra Large Field Angio is specifically designed for angiographic imaging, a specialized subset of radiology where blood vessels are visualized using contrast agents. It automates cassette handling during fluoroscopic procedures, which are commonly used in diagnostic and interventional cardiology, vascular surgery, and neuroangiography.