(85 days)
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No
The summary does not mention AI, ML, or any related concepts like deep learning, neural networks, or specific algorithms typically associated with AI/ML in medical imaging. The description focuses on the hardware components and intended use for general diagnostic imaging.
No.
The device is described as an x-ray imaging system for diagnostic angiographic fluoroscopy and radiographic studies, which are diagnostic rather than therapeutic purposes.
Yes
Explanation: The "Intended Use / Indications for Use" section states that the system is "intended to be used for general purpose diagnostic angiographic fluoroscopy and radiographic studies." This directly indicates its use for diagnosis.
No
The device description explicitly states it is an "angiographic positioner with a 32 cm intensifier, for use with a vascular table and an x-ray system," indicating it is a hardware system, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "general purpose diagnostic angiographic fluoroscopy and radiographic studies." This describes an imaging system used to visualize structures within the body using X-rays, not a test performed on samples taken from the body (like blood, urine, or tissue).
- Device Description: The description confirms it's an "angiographic positioner with a 32 cm intensifier," which is a component of an X-ray imaging system.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any other elements typically associated with in vitro diagnostics.
IVDs are tests performed outside the body on biological specimens to provide information about a person's health. This device is used on the body to create images.
N/A
Intended Use / Indications for Use
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 intended for general purpose diagnostic angiographic fluoroscopy and radiography studies.
Product codes
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Device Description
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
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
x-ray
Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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.
0
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 |
| Carlos Controller Comparis Comparis Comparis Comparis Comparis Comparis Comparis Comparis Compressional Compressional Compressional Compressional Compressional Compressional | |
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 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.