Skip to content

ISAAC 1.5 T MR System

by Chi, Inc.

510(k) K020268

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 NumberK020268 Date25 Apr 2002ClearedStatusActive

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  • Withdrawn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
LNH
Device Class
Class II
Regulation
21 CFR Part 892.1000
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 26 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 ISAAC 1.5 T MR System is a 1.5 Tesla whole-body magnetic resonance imaging system intended for general diagnostic use. It is classified as a Class II medical device under the U.S. Food and Drug Administration's (FDA) regulatory framework.

The system is supplied as a complete imaging solution and is intended for use in clinical settings. It is cleared under FDA 510(k) traditional pathway and is subject to regulatory oversight as a Class II device.

Questions

AI-generated answers, 26 Sep 2026

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

  • What is the primary use of the ISAAC 1.5 T MR System?

    The ISAAC 1.5 T MR System is a whole-body magnetic resonance imaging system intended for general diagnostic use in clinical settings.

  • How is the device regulated in the United States?

    The device is classified as a Class II medical device and is cleared under the FDA 510(k) traditional pathway.

  • What is the magnetic field strength of this MRI system?

    The system operates at a magnetic field strength of 1.5 Tesla.