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Echelon C MRI System

by Hitachi Medical Systems America, Inc.

510(k) K083533

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

2 closed

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 NumberK083533 Date17 Feb 2009ClearedStatusActive

Recalls

2 recalls · FDA

    • Terminated Z-2337-2021 FDA Class II initiated 29 Jul 2021

    There was no label on the pad packaging or notification in the user manual that the table pads contained dry natural rubber which is required by the Code of Federal Regulations section 21CFR801.437.

    • Terminated Z-1542-2017 FDA Class II initiated 16 Apr 2015

    Image data transferred from the MRI system to a workstation showed errors on the slice position reference image.

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  • Withdrawn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

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