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Namic Contrast Savings Delivery System

by North American Instrument Corp.

510(k) K903493

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK903493 Date26 Mar 1991ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
IZI
Device Class
Class II
Regulation
21 CFR Part 892.1600
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 25 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Namic Contrast Savings Delivery System is a System, X-ray, Angiographic device used for radiologic visualization of the heart, blood vessels, or lymphatic system during or after injection of a contrast medium. It is classified as a Class 2 device and is used in the medical specialty of Radiology.

The device is supplied with a product code of IZI and is regulated under regulation number 892.1600. It has been cleared by the FDA with a 510(k) number of K903493, with a decision date of 1991-03-26. The device is intended for use in radiology and has been classified as substantially equivalent.

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