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Ergo++ Version 1.7

by 3D Line Medical Systems S.R.L.

510(k) K080601

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 NumberK080601 Date6 Jun 2008ClearedStatusActive

Recalls

2 recalls · FDA

    • Terminated Z-0234-2018 FDA Class II initiated 1 Sep 2017

    Incorrect DICOM mapping of the exported collimator or couch angles from ERGO, which would lead to incorrect rotation of the collimator or couch when using a MLC device for planning.

    • Terminated Z-2645-2011 FDA Unclassified (pre-2012) initiated 11 Dec 2009

    ERGO Release 1.6.3 is overestimating the MU values.

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  • Withdrawn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
MUJ
Device Class
Class II
Regulation
21 CFR Part 892.5050
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Other devices from 3D Line Medical Systems S.R.L.

  • Argos

    Class II