Preciseplan 2.0

510(k) K022411

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

4 closed

Documents

FDA record

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

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK022411	Date20 Sep 2002Cleared	StatusActive

4 recalls · FDA

- Terminated Z-1109-2010 FDA Unclassified (pre-2012) initiated 30 Sep 2008
The new "DICOM CT with Body Outline" method to create a patient case in PrecisePLAN 2.15 may produce incorrect results for some customers, given several input conditions encountered in the field. Discontinue use of this method of creating a patient case until FCO 772 00 540 064, (entitled "Update for Patient creation method using DICOM CT with Body Outline"), is received from Elekta to update th
- Terminated Z-1556-2011 FDA Unclassified (pre-2012) initiated 5 Feb 2008
When using the 'Beam Edit" function to modify a bean in an unlocked Fraction Group, there are two conditions that may cause the user to unitentionally modify a locked fraction group.
- Terminated Z-1476-2011 FDA Unclassified (pre-2012) initiated 28 Jan 2008
PrecisePLAN generates digitally Reconstructed Radiographs (DRR;s) with a shift in the superior direction.
- Terminated Z-1406-2010 FDA Unclassified (pre-2012) initiated 15 Mar 2006
Error in dose rates which were calculated at exactly twice the expected values.

1 jurisdiction

United States — FDA 510(k) Active

510(k)