FLOUROSPOT T.O.P.

K961871 · Siemens Medical Solutions USA, Inc. · LLZ · Jul 31, 1996 · Radiology

Device Facts

• Record ID: K961871
• Device Name: FLOUROSPOT T.O.P.
• Applicant: Siemens Medical Solutions USA, Inc.
• Product Code: LLZ · Radiology
• Decision Date: Jul 31, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2

Intended Use

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 exposures, urological examinations, vascular and non-vascular procedures as well as general angiography, interventional angiography, peripheral angiography and DSA (Digital Subtraction Angiography).

Device Story

Fluorospot T.O.P. is a digital imaging system component for radiographic/fluoroscopic and interventional angiographic suites; acquires, records, and displays radiographic images. Operated by trained healthcare professionals in clinical settings. System supports contrast-enhanced fluoroscopy, digital tomography, and Digital Subtraction Angiography (DSA). Output provides high-quality images for clinical review, aiding diagnostic and interventional decision-making. Device integrates into existing X-ray suites; facilitates data transfer to PACS via DICOM 3.0/ACR/NEMA standards.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

10-bit digital imaging system; supports 1024² and 2048² image formats. Interfaces with Siemens Sienet PACS; supports DICOM 3.0 and ACR/NEMA data transfer formats. Complies with 21 CFR Subchapter J performance standards.

Indications for Use

Indicated for use by trained healthcare professionals for digital acquisition, recording, and display of radiographic images during fluoroscopic, urological, vascular, non-vascular, and interventional angiographic procedures.

Regulatory Classification

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.

Special Controls

*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).

Predicate Devices

• Fluorospot T.O.P. (K914525)
• Polytron T.O.P. (K933664)
• QL MultiPulse 2048 (K933299)

Submission Summary (Full Text)

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SIEMENS
JUL 31 1996
K96/871

# 510 (k) SUMMARY

## I. GENERAL INFORMATION:

### Establishment:

- **Address:**
Siemens Medical Systems, Inc.
186 Wood Avenue South
Iselin, NJ. 08830

- **Registration Number:**
2240869

- **Contact Person:**
Kathleen Rutherford
Manager, Regulatory Submissions
Telephone: [phone]
TELEFAX: [phone]

### Date of Summary Preparation:

### Device Name:

- **Trade Name:**
Fluorospot T.O.P.

- **Common Name:**
Digital Imaging System

- **Classification Name:**
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
186 Wood Avenue South
Iselin, NJ 08830
Tel: [phone]
Fax: [phone]

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SIEMENS

## Intended Use:

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 exposures, urological examinations, vascular and non-vascular procedures as well as general angiography, 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. Radiographic/Fluoroscopic x-ray systems configured with the Fluorospot T.O.P. with 2048² format and large image fields will acquire and display images with detailed recognition and resolution. The Fluorospot T.O.P. is designed to directly interface with the Siemens Sienet (Siemens Picture Archival Communication System) 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. | Siemens Medical Systems, Inc. | K914525 |
| Polytron T.O.P. | Siemens Medical Systems, Inc. | K933664 |
| QL MultiPulse 2048 | InfiMed, Inc. | K933299 |

Kathleen Rutherford
Manager, Regulatory Submissions
5/14/96
Date