(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.
Therefore, I cannot extract the requested information as it is not present in the provided text.
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SIEMENS
JUL 31 1996
510 (k) SUMMARY
I. GENERAL INFORMATION: Establishment:
- · Address:
Siemens Medical Systems, Inc. 186 Wood Avenue South Iselin, NJ. 08830
· Registration Number:
•Contact Person:
2240869
Kathleen Rutherford Manager, Regulatory Submissions Telephone: (908) 321- 4779 TELEFAX: (908) 321 - 4841
Date of Summary Preparation:
Device Name:
· Trade Name:
Fluorospot T.O.P.
· Common Name:
· Classification Name:
Digital Imaging System
Image Intensified Fluoroscopic X-ray System
·Classification:
Class II
Performance Standards:
21 CFR, Subchapter J
All system components to which the above standard applies are certified to conform with 21 CFR subchapter J
II. SAFETY AND EFFECTIVENESS INFORMATION SUPPORTING THE SUBSTANTIAL EQUIVALENCE DETERMINATION.
Device Description:
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.
Siemens Medical Systems, Inc.
Imaging Systems Group
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SIEMENS
Intended Use:
The Fluorospot T.O.P. is intended for use with radiographic fluoroscopic and The Fluorospor Tronal angiography x-ray systems to digitally acquire, univelsar interventional angrops if images. The Fluorospot T.O.P. enables the tecord and display radiographic integressional to consistently acquire high quality images for fluoroscopic examinations with contrast medium, digital tomographical Huoroscopic examinations, wascular and non-vascular procedures as exposures: arologicaphy, interventional angiography, peripheral angiography and DSA (Digital Subtraction Angiography).
Technological Characteristics:
The Fluorospot T.O.P. is a 10 bit digital imaging system. Images can be acquired and displayed in two formats, 10242 and 20482. acquired and displayed in o x-ray systems configured with the Fluorospot Radiographic) National and large image fields will acquire and display 1.0.1 with detailed recognition and resolution. The Fluorospot T.O.P. is mages with details interface with the Siemens Sienet (Siemens Picture designed to directly interrasses m) and transfer data in a DICOM 3.0 and ACR/NEMA formats.
General Safety and Effectiveness Concerns:
Instructions for use are included within the device labeling and the information provided will enable the trained healthcare professional to operate the device in a safe and efficacious manner. Furthermore the operators are health care professionals familiar with and responsible for the X-ray studies to be performed. To minimize electrical, mechanical and radiation hazards, Siemens adheres to recognized and established industry practice, and all equipment is subject to final performance testing.
Substantial Equivalence:
The Fluorospot T.O.P. digital imaging system has similar technological characteristics and intended use as the predicate devices described in the Equivalancy Information section of this premarket notification. Siemens Medical Systems, Inc. believes that the Fluorospot T.O.P. , the subject of this premarket notification, is substantially equivalent to the following medical devices currently in commercial distribution.
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SIEMENS
Model
Company
FDA K-Number
Fluorospot T.O.P. Polytron T.O.P. QL MultiPulse 2048
Katlen Rutherford
Kathleen Rutherford Manager, Regulatory Submissions
Siemens Medical Systems, Inc. K914525 Siemens Medical Systems, Inc. InfiMed, Inc.
5/14/96
Date
§ 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).