📋 FDA Reference
Photomulitplier Tube Interface P C Board
U.S. Imaging
Summary: The photomultiplier tube interface PC board by U.S. Imaging is a medical device used in imaging systems for tumor ablation. It is primarily utilized by radiologists and oncologists in clinical settings.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K890878 ↗
Decision Date ?
March 14, 1989
Product Code ?
JAA
Device Class ?
Class 2
Evidence ?
0 studies
This device was cleared through the FDA 510(k) pathway on March 14, 1989. It is manufactured by U.S. Imaging and classified as a Class II device under product code JAA.
What It Is
The photomultiplier tube interface PC board is a component used in medical imaging systems, specifically those involved in tumor ablation procedures. It works by converting light signals into electrical signals, which are then used to create detailed images of tissues. This technology is crucial for accurate imaging in oncology, aiding in the precise targeting of tumors during ablation procedures.
FDA-Cleared Indications
- For use as a component of a medical imaging system associated with tumor-ablation procedures, as described in the available device record.
Clinical Applications
- Supporting signal processing within an imaging system used during image-guided tumor-ablation procedures.
- Converting optical signals from a photomultiplier tube into electrical signals for image formation or processing.
- Supporting visualization of tissue and treatment targets when incorporated into a compatible oncology imaging system.
Practical Considerations
- This is a system component rather than a standalone patient-contacting device; compatibility with the host imaging system is essential.
- Installation, calibration, troubleshooting, and replacement should follow the imaging-system manufacturer's service documentation and qualified biomedical-engineering procedures.
- The record does not specify board dimensions, connector type, electrical specifications, or supported imaging-system models; these details must be confirmed with the manufacturer or service documentation.
- MRI safety cannot be determined from the available record. Because the board contains electronic components, it should not be brought into an MRI environment unless the complete system has documented MR safety or conditional labeling.
- The component itself does not contact the patient, so patient contraindications and procedural risks generally relate to the complete imaging system and the tumor-ablation procedure rather than the PC board.
Frequently Asked Questions
What is the photomultiplier tube interface PC board used for?
It is used in medical imaging systems to convert light signals into electrical signals, aiding in tumor ablation procedures.
What specialties typically use this device?
Radiologists and oncologists typically use this device in clinical settings for imaging and tumor ablation procedures.
What are the FDA-cleared indications?
The device is indicated for use in imaging systems that assist in tumor ablation, providing detailed images for precise targeting of tumors.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.