Radiation Beam Data Acquistioin Systems
by Computerized Medical Systems, Inc.
510(k) K854880
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK854880 | Date10 Jan 1986 | 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- Withdrawn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
- 510(k) Number
- FDA Product Code
- KPQ
- Device Class
- Class II
- Regulation
- 21 CFR Part 892.5840
- Advisory Committee
- Radiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
This device is a System, Simulation, Radiation Therapy as classified under FDA regulation 892.5840. It is designed to acquire and process radiation beam data, enabling precise measurement and analysis for radiation therapy planning and simulation. The system supports radiology applications by providing critical data for treatment optimization and dose calculation in radiotherapy environments.
The Radiation Beam Data Acquisition System is supplied as a Class II medical device and was cleared under FDA 510(k) K854880 in 1986, with a Substantially Equivalent (SESE) determination by the Radiology (RA) advisory committee. It is intended for use in radiology settings and operates as a reusable device, though sterility and single-use specifications are not detailed in the regulatory filing. Compliance with FDA regulation 892.5840 ensures adherence to safety and performance standards for radiation therapy simulation systems.
Other devices from Computerized Medical Systems, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the Radiation Beam Data Acquisition System used for?
The Radiation Beam Data Acquisition System is designed to acquire and process radiation beam data, enabling precise measurement and analysis for radiation therapy planning and simulation. It provides critical data to optimize treatment and calculate doses accurately in radiotherapy environments, ensuring safer and more effective patient care.
How is the Radiation Beam Data Acquisition System supplied and intended for use?
This system is supplied as a reusable Class II medical device, intended exclusively for use in radiology settings. It was cleared under FDA 510(k) K854880 in 1986, with a Substantially Equivalent (SESE) determination by the Radiology (RA) advisory committee, ensuring compliance with FDA regulation 892.5840 for radiation therapy simulation systems.
Is sterility or single-use specified for this device?
The regulatory filing does not explicitly detail sterility or single-use specifications for the Radiation Beam Data Acquisition System. However, as a reusable device, it is designed for repeated use in clinical environments, adhering to safety and performance standards for radiation therapy applications.
What regulatory pathway was followed for this device?
The device underwent a traditional 510(k) review process, submitted to the FDA on December 6, 1985, and cleared on January 10, 1986. It was determined to be Substantially Equivalent (SESE) to a legally marketed predicate device by the Radiology (RA) advisory committee, ensuring compliance with FDA standards for radiation therapy simulation systems.
Which medical specialty does this system support?
The Radiation Beam Data Acquisition System is specifically designed to support radiology applications, providing essential data for treatment planning, dose calculation, and simulation in radiotherapy. Its functionality aligns with the needs of radiology professionals to enhance precision in patient care.