← Product Code [IZI](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZI) · K960575 # ADVANTX LCV+ (K960575) _GE Medical Systems · IZI · May 7, 1996 · Radiology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZI/K960575 ## Device Facts - **Applicant:** GE Medical Systems - **Product Code:** [IZI](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZI.md) - **Decision Date:** May 7, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 892.1600 - **Device Class:** Class 2 - **Review Panel:** Radiology ## Indications for 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. ## Regulatory 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) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} 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: 414-544-3894 Fax: 414-544-3863 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. --- **Source:** [https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZI/K960575](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZI/K960575) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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