ADVANTX LCV+

K960575 · GE Medical Systems · IZI · May 7, 1996 · Radiology

Device Facts

• Record ID: K960575
• Device Name: ADVANTX LCV+
• Applicant: GE Medical Systems
• Product Code: IZI · Radiology
• Decision Date: May 7, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1600
• Device Class: Class 2

Intended Use

The Advantx LVC+ x-ray imaging system is intended to be used for general purpose diagnostic angiographic fluoroscopy and radiographic studies.

Device Story

Advantx LCV+ is an angiographic and radiographic positioner; utilizes 32 cm intensifier; integrates with vascular table and x-ray system. Used in clinical settings by medical professionals for diagnostic imaging. System incorporates hardware and software redundancies to mitigate single-point failures regarding unintended motion. Safety managed via FMEA and adherence to UL 187 standards. Output provides diagnostic x-ray images for clinical assessment.

Clinical Evidence

Bench testing only; system evaluation performed to ensure performance to specifications and Federal Regulations; FMEA conducted to control potential hazards.

Technological Characteristics

Materials compliant with UL 187; 32 cm intensifier; energy source 220 V ac 50/60 Hz; includes hardware and software redundancies for motion control.

Indications for Use

Indicated for patients requiring general purpose diagnostic angiographic fluoroscopy and radiographic studies.

Regulatory Classification

Identification

An angiographic x-ray system is a device intended for radiologic visualization of the heart, blood vessels, or lymphatic system during or after injection of a contrast medium. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Submission Summary (Full Text)

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K960575

MAY - 7 1996

GE Medical Systems

P.O. Box 414, W-657
Milwaukee, WI 53201
USA

# SUMMARY OF SAFETY & EFFECTIVENESS
8 February, 1996

This 510(k) summary of safety and effectiveness information is submitted in accordance with the requirements of 21CFR Part 807.87(h).

Contact:
Larry A. Kroger, Ph.D.
Phone: [phone]
Fax: [phone]

Product:
Advantx LCV+
X-ray Imaging System
Manufactured by GE Medical Systems - Europe, Buc, France
Distributed by GE Medical Systems, Milwaukee, WI

## Indications for Use
The Advantx LVC+ x-ray imaging system is intended to be used for general purpose diagnostic angiographic fluoroscopy and radiographic studies.

## Identification of the Product
Name: Advantx LCV+
Mfg: GE Medical Systems - Europe
238 Rue de la Miniere
78530 Buc, FRANCE

## Indications for Use
The Advantx LCV+ imaging system is intended for general purpose diagnostic angiographic fluoroscopy and radiography studies.

## Device Descriptions
The Advantx LCV+ imaging system is an angiographic and radiographic positioner with a 32 cm intensifier, for use with a vascular table and an x-ray system.

**Materials:** All construction and materials are compliant with UL 187.

**Design:** There are hardware and software redundancies to prevent single point failures that could cause unintended motion.

**Energy Source:** 220 V ac 50/60 Hz

## Marketing History
In the opinion of GE Medical Systems, the LCA is of a comparable type and substantially equivalent to currently marketed diagnostic x-ray systems that comply with the same or equivalent standards and have the same intended uses.

## Adverse Effects on Health
The potential hazards (unintended emission of x-rays, excessive radiation, mechanical and electrical) are identified in a Hazards Analysis and controlled by:
- Failure Mode and Effects Analysis (FMEA) to demonstrate the non-existence or extremely low probability of unwanted events.
- System evaluation to insure performance to specification and Federal Regulations.
- Adherence to Industrial Standards (UL).

## Conclusions
Use of the Advantx LCV+ imaging system does not result in any new potential safety risks.