(85 days)
The Advantx LVC+ x-ray imaging system is intended to be used for general purpose diagnostic angiographic fluoroscopy and radiographic studies.
The Advantx LCV+ imaging system is an angiographic positioner with a 32 cm intensifier, for use with a vascular table and an x-ray system.
The provided document is a 510(k) summary for the GE Advantx LCV+ X-ray Imaging System, submitted in 1996. This document does not contain any information regarding acceptance criteria for device performance or a study proving that the device meets such criteria.
The summary primarily focuses on the device's indications for use, description, marketing history, and a general statement about safety, comparing it to existing diagnostic X-ray systems. It mentions a "Hazards Analysis" and "Failure Mode and Effects Analysis (FMEA)" to control potential hazards and ensure performance to specification and Federal Regulations, but it does not specify what those performance specifications are or how they were demonstrated.
Therefore, I cannot fulfill the request to describe the acceptance criteria and a study proving the device meets them based on the provided text. The requested information regarding a table of acceptance criteria, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, and ground truth establishment is not present in this 510(k) summary.
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Image /page/0/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined within a circular border. The letters and the border are in black, while the background is white.
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: 414-544-3894 |
|---|---|
| Fax:414-544-3863 | |
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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 - Europe238 Rue de la Miniere78530 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 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.
§ 892.1600 Angiographic x-ray system.
(a)
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.(b)
Classification. Class II.