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Moduleaf

by Mrc Systems GmbH

510(k) K030609

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 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 · Special NumberK030609 Date17 Mar 2003ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-1184-2012 FDA Not yet classified initiated 7 Feb 2012

    This correction is being performed to update the safety knob of the Siemens brand mMLC (ModuLeaf) to conform to tie IEC 60601-1 safety standard.

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  • Withdrawn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
IXI
Device Class
Class II
Regulation
21 CFR Part 892.5710
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

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