BLA-800A Beam Limiting Device
510(k) K954310
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK954310 | Date18 Oct 1995 | StatusActive |
Recalls
No FDA recalls found in the data synced 5 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Full name
- Bla-800A
- 510(k) Number
- FDA Product Code
- KPW
- Device Class
- Class II
- Regulation
- 21 CFR Part 892.1610
- Advisory Committee
- Radiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The BLA-800A is a beam-limiting device designed for diagnostic X-ray systems, specifically categorized under the FDA’s product code KPW. As a collimator, it restricts the X-ray beam to the area of interest, reducing patient exposure and improving image quality by minimizing scatter radiation. This device is integrated into radiology imaging workflows to ensure precise and controlled radiation delivery during fluoroscopic procedures.
The BLA-800A is supplied as a reusable component for Toshiba Medical Systems’ Cath/Angio imaging systems and is intended for use in radiology settings. It operates on a 24V DC input with a power consumption of 35W and is classified as a Class II medical device under FDA regulations (21 CFR 892.1610). While no explicit sterility requirements are stated, it is typically handled in a clean environment to maintain functionality and hygiene. Authorized for use in the United States via FDA 510(k) clearance (K954310), this device adheres to radiology-specific standards for diagnostic imaging.
Other devices from Toshiba Medical Systems
Questions
AI-generated answers, 1 Oct 2026
What is the BLA-800A used for in diagnostic imaging?
The BLA-800A is a beam-limiting device (collimator) designed specifically for diagnostic X-ray systems, particularly in fluoroscopic procedures. It restricts the X-ray beam to the precise area of interest, which minimizes scatter radiation and reduces unnecessary patient exposure while enhancing image clarity and quality.
Is the BLA-800A intended for single-use or reusable applications?
The BLA-800A is supplied as a reusable component for Toshiba Medical Systems’ Cath/Angio imaging systems. While no explicit sterility requirements are stated in the documentation, it is recommended to handle the device in a clean environment to maintain both functionality and hygiene standards.
What power requirements does the BLA-800A have?
The BLA-800A operates on a 24V DC input with a power consumption of 35W. These specifications ensure compatibility with Toshiba’s Cath/Angio imaging systems while maintaining efficient performance during fluoroscopic procedures.
How is the BLA-800A regulated in the United States?
The BLA-800A is authorized for use in the U.S. through FDA 510(k) clearance (K954310), classified as a Class II medical device under 21 CFR 892.1610. This regulatory pathway confirms its substantial equivalence to a predicate device, ensuring compliance with radiology-specific standards for diagnostic imaging.
Which Toshiba imaging systems is the BLA-800A compatible with?
The BLA-800A is integrated into Toshiba Medical Systems’ Cath/Angio imaging systems. Its design ensures seamless integration into radiology workflows, particularly for fluoroscopic procedures where precise beam control is essential for patient safety and image quality.