Advantx LCA Angiographic System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K945375 FDA 510(k)
- FDA Product Code
- IZI FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.1600 FDA 510(k)
- Regulation Number
- 892.1600 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Advantx LCA Angiographic System is a Class II medical device classified as an X-ray, angiographic system (product code IZI). It is designed for use in general vascular and interventional radiology procedures, providing high-quality imaging to support diagnostic and therapeutic interventions.
This system is intended for use in clinical settings where fluoroscopic imaging is required, such as catheterization labs and interventional radiology suites. It is a reusable device, supplied sterile or non-sterile as per procedural needs, and adheres to MRI safety standards for the specified environment. Authorized under FDA 510(k) clearance (K945375) with a decision date of January 30, 1995, it operates under regulatory requirements outlined in 21 CFR 892.1600.
Frequently asked questions
What types of procedures is the Advantx LCA Angiographic System primarily used for in clinical settings?
The Advantx LCA Angiographic System is designed for general vascular and interventional radiology procedures, providing high-quality fluoroscopic imaging. This makes it suitable for diagnostic and therapeutic interventions in catheterization labs and interventional radiology suites, where real-time imaging is essential for guiding procedures like catheter placements, angioplasties, or stent placements.
Is the Advantx LCA Angiographic System reusable, and how should it be handled to maintain sterility?
Yes, the Advantx LCA Angiographic System is a reusable device. Sterility is managed based on procedural needs—it can be supplied either sterile or non-sterile. Proper cleaning, disinfection, and maintenance protocols must be followed to ensure safe reuse, adhering to manufacturer guidelines and facility infection control policies.
Does the Advantx LCA Angiographic System comply with MRI safety standards, and if so, in what environments?
Yes, the Advantx LCA Angiographic System adheres to MRI safety standards for specified environments. This means it is designed to be used in clinical settings where MRI compatibility is a consideration, ensuring safe operation when imaging patients who may require MRI procedures or when the device is positioned near MRI equipment.
What regulatory pathway was followed for FDA clearance of the Advantx LCA Angiographic System, and when was it approved?
The Advantx LCA Angiographic System received FDA clearance through a 510(k) submission, classified as Substantially Equivalent under the Traditional review pathway. It was authorized on January 30, 1995, with the Radiology (RA) Advisory Committee providing input during the review process. The clearance number is K945375.
How many different model or variant identifiers are associated with the Advantx LCA Angiographic System in regulatory records?
The Advantx LCA Angiographic System is linked to 50+ distinct FEI (Facility Equipment Identifier) numbers in regulatory records, indicating multiple variants or configurations may exist. These identifiers reflect different installations or minor model variations tracked by the FDA, though the core functionality remains consistent across all variants.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: GE HealthCare - Advantx LCA Community, Manuals and Specifications ..., K945375 - ADVANTX LCA | FDA 510 (k) | GE Medical Systems, GE HealthCare - Advantx LCA Manuals and Documents | Medical, ADVANTX LCA (K945375) — FDA 510(k) | Innolitics, Class 2 Device Recall GE Healthcare Advantx LCA
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K945375 | Class II | Active |
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Manufacturer
- Manufacturer
- Ge Medical Systems
Sources (1)
- FDA 510(k) K945375 24 fields · synced Oct 6, 2026