(77 days)
The Fluorospot T.O.P. is intended for use with radiographic fluoroscopic and universal interventional angiography x-ray systems to digitally acquire, record and display radiographic images. The Fluorospot T.O.P. enables the trained healthcare professional to consistently acquire high quality images for fluoroscopic examinations with contrast medium, digital tomographical fluoroscopic examinations, vascular and non-vascular procedures as exposures: urologicaphy, interventional angiography, peripheral angiography and DSA (Digital Subtraction Angiography).
The Siemens Fluorospot T.O.P. is a digital imaging system for radiographic/fluoroscopic, angiographic and interventional procedures. The Fluorospot T.O.P. is designed to acquire, record and display radiographic images. The Fluorospot T.O.P. digital imaging system, is an optional integral component of a radiographic/fluoroscopic universal interventional angiographic suite, as such it is not considered a stand alone device.
The provided text is a 510(k) summary for the Siemens Fluorospot T.O.P. digital imaging system from 1996. This document does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert evaluations.
The summary describes the device, its intended use, technological characteristics, and claims substantial equivalence to predicate devices based on similar technological characteristics and intended use. The core of the document focuses on regulatory compliance and general safety.
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§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).