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Innova and Innova 2000 S

FDA 510(k)

Class II (US FDA 510(k))

510(k) K022322

by Ge Medical Systems, Inc.

Identifiers

510(k) Number
K022322 FDA 510(k)
FDA Product Code
OWB FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 892.1650 FDA 510(k)
Regulation Number
892.1650 FDA 510(k)
Advisory Committee
Radiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Innova and Innova 2000 S are interventional fluoroscopic X-ray systems designed for real-time imaging during surgical and diagnostic procedures. These devices provide high-resolution visualisation of internal anatomical structures, enabling precise guidance for interventions such as angiography, cardiology, and orthopaedic procedures. Their advanced imaging capabilities support critical decision-making in radiology settings.

These systems are supplied as reusable medical equipment, intended for use in clinical environments such as hospitals and interventional suites. They are not sterile at shipment but are designed for repeated use with appropriate cleaning and maintenance protocols. The devices comply with FDA 510(k) clearance under the classification of Class II medical devices (OWB product code) and are regulated under 21 CFR 892.1650. Multiple model-specific registration numbers are associated with their distribution.

Frequently asked questions

What procedures does the Innova 2000 S support with its real-time imaging?

The Innova 2000 S provides high-resolution imaging for critical interventions like angiography, cardiology procedures (e.g., coronary angiography, percutaneous coronary interventions), and orthopaedic surgeries. Its real-time visualization helps clinicians guide catheters, implants, or other instruments with precision, reducing procedural risks and improving outcomes in interventional radiology settings.

Is the Innova 2000 S sterile upon delivery, and how should it be prepared for use?

The Innova 2000 S is not sterile at shipment. As reusable equipment, it must undergo thorough cleaning and maintenance following the manufacturer’s protocols before each use. Sterilization is not required for this device, but proper disinfection and inspection are essential to ensure safety and functionality in clinical environments like hospitals or interventional suites.

What regulatory pathway does the Innova 2000 S follow, and what classification does it hold?

The Innova 2000 S is classified as a Class II medical device under the FDA’s 510(k) clearance pathway, specifically filed under product code OWB (Interventional Fluoroscopic X-Ray Systems). It was determined substantially equivalent to a predicate device and complies with 21 CFR 892.1650, ensuring it meets performance standards for interventional imaging without requiring a premarket approval (PMA).

How many model-specific registration numbers are associated with the Innova and Innova 2000 S?

The Innova and Innova 2000 S systems are linked to over 80 distinct registration numbers (e.g., 3005706667, 3015232217, 1000188474) across their distribution. These identifiers correspond to model variants or configurations but share the same core design and FDA-cleared functionality for interventional fluoroscopy. Each number may reflect updates or regional adaptations while maintaining compliance with the original 510(k) clearance.

What maintenance protocols are recommended for the Innova 2000 S to ensure longevity and performance?

Since the Innova 2000 S is reusable, its longevity depends on strict adherence to GE Medical Systems’ cleaning, calibration, and maintenance guidelines. This includes regular disinfection of external surfaces, periodic checks of imaging quality, and servicing by certified technicians to address wear on components like the X-ray tube, detector, or fluoroscopy controls. Proper storage in a controlled environment—protected from moisture, dust, and temperature extremes—also extends the device’s operational life in high-use settings like cardiac catheterization labs.

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 INNOVA 2000 PREINSTALLATION MANUAL Pdf Download, GE HealthCare - Innova 2000 Community, Manuals and Specifications ..., GE Innova And Innova 2000 - allmed.wiki, Flat Field Innova 2000, Interventional Image Guided Systems | GE ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Ge Medical Systems, Inc.

Sources (1)

  • FDA 510(k) K022322 24 fields · synced Oct 6, 2026