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IMEX 8000 Personal Cascular Lab

FDA 510(k)

Class II (US FDA 510(k))

510(k) K942243

by Imex Medical Systems, Inc.

Identifiers

510(k) Number
K942243 FDA 510(k)
FDA Product Code
IYO FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 892.1560 FDA 510(k)
Regulation Number
892.1560 FDA 510(k)
Advisory Committee
Radiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The IMEX 8000 Personal Cascular Lab is a portable ultrasound system designed for vascular imaging. It is classified as a Class II diagnostic ultrasound device, intended for use in radiology to visualize blood vessels and assess circulatory conditions.

This device is supplied as a reusable medical instrument and is cleared for use in MRI environments, though specific MRI safety information should be verified per facility protocols. Manufactured by Imex Medical Systems, Inc., it holds an FDA 510(k) clearance under K-number K942243, granted in 1995, with a substantially equivalent determination by the Radiology Advisory Committee.

Frequently asked questions

What types of blood vessels can the IMEX 8000 Personal Cascular Lab visualize, and how is it primarily used in clinical settings?

The IMEX 8000 is designed specifically for vascular imaging, allowing clinicians to visualize blood vessels and assess circulatory conditions. It is primarily used in radiology departments to evaluate peripheral arteries, veins, and other vascular structures, helping diagnose conditions like peripheral artery disease, venous insufficiency, or arterial blockages. Its portability makes it suitable for bedside or point-of-care evaluations where traditional ultrasound systems may not be as accessible.

Is the IMEX 8000 Personal Cascular Lab intended for single-use or reusable applications, and what does this mean for maintenance?

The IMEX 8000 is explicitly supplied as a reusable medical instrument, meaning it is designed for repeated use across multiple patients after proper cleaning, disinfection, and maintenance. This requires adherence to facility protocols for reprocessing to ensure safety and functionality. Reusability also means it can be integrated into existing workflows without the need for single-use replacements, though facilities must follow manufacturer guidelines for servicing and calibration to maintain performance.

Can the IMEX 8000 Personal Cascular Lab be used in MRI environments, and what precautions should be taken?

Yes, the IMEX 8000 is cleared for use in MRI environments, though its compatibility depends on facility-specific MRI safety protocols. Since it is a reusable device, clinicians must verify that all components—including cables, probes, and housing—are non-ferromagnetic and safe for use near MRI machines. Always consult your facility’s MRI safety guidelines to ensure proper positioning and operation to avoid interference or safety hazards.

What regulatory pathway was followed for the FDA clearance of the IMEX 8000, and what does this mean for its clinical use?

The IMEX 8000 received FDA clearance through a Traditional 510(k) pathway, with a substantially equivalent (SESE) determination by the Radiology Advisory Committee (RA) in 1995 under K-number K942243. This means the device was deemed comparable to legally marketed predecessors in terms of technology and safety, ensuring it meets FDA standards for diagnostic ultrasound systems used in vascular imaging. Clinicians can rely on this clearance as evidence of its regulatory review, though ongoing adherence to manufacturer instructions and facility protocols remains critical for safe operation.

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: K942243 FDA 510(k) - IMEX 8000 PERSONAL CASCULAR LAB, IMEX Frankfurt - 11-13 May, 2027 — Meetings & events show, Imex 8000 Personal Cascular Lab - Beudamed, Imex 8000 Personal Cascular Lab - allmed.wiki, IMEX 8000 PERSONAL CASCULAR LAB (K942243) — FDA 510 (k) | Innolitics

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Imex Medical Systems, Inc.

Sources (1)

  • FDA 510(k) K942243 24 fields · synced Sep 19, 2026