← Back to catalogue

Disposable CT/MR Syringes For Nemoto Injectors

FDA 510(k)

Class II (US FDA 510(k))

510(k) K051799

by Coeur, Inc.

Identifiers

510(k) Number
K051799 FDA 510(k)
FDA Product Code
DXT FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 870.1650 FDA 510(k)
Regulation Number
870.1650 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Disposable CT/MR Syringes for Nemoto Injectors are plastic, single-use syringes designed for use with Nemoto CT and MR injector systems. These devices function as mechanical fluid delivery components to facilitate the administration of contrast media or saline into patient vasculature during diagnostic imaging procedures.

These syringes are available in 20mL, 100mL, and 200mL sizes and are manufactured from polypropylene or PET. They are intended for operation by clinical staff in radiology settings and are supplied sterile. This device is authorized under FDA 510(k) clearance K051799.

Frequently asked questions

What are these syringes used for?

These syringes function as mechanical fluid delivery components for Nemoto CT and MR injector systems. They are used by clinical staff to administer contrast media or saline into a patient's vasculature during diagnostic imaging procedures.

Are these syringes reusable?

No, these are single-use devices. They are designed to be disposed of after a single procedure to ensure patient safety and maintain sterility standards.

What sizes are available?

The syringes are available in three distinct volume capacities: 20mL, 100mL, and 200mL, allowing for flexibility based on the specific requirements of the diagnostic imaging procedure.

How are these syringes supplied?

These devices are supplied sterile to ensure they are ready for immediate clinical use in a radiology setting. They are manufactured from polypropylene or PET materials.

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: DISPOSABLE CT/MR SYRINGES FOR NEMOTO INJECTORS by COEUR, INC. | FDA 510 ..., Disposable Ct/Mr Syringes for Nemoto Injectors, Disposable Ct/Mr Syringes for Nemoto Injectors, Disposable Ct/Mr Syringes for Nemoto Injectors

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Coeur, Inc.

Sources (1)

  • FDA 510(k) K051799 24 fields · synced Sep 21, 2026