Leksell Gammaplan

510(k) K973441

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 10 Oct 2026. What this means

Regulatory status

as of registry sync 10 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK973441	Date1 Apr 1998Cleared	StatusActive

4 recalls · FDA

- Terminated Z-0307-2012 FDA Unclassified (pre-2012) initiated 23 Jun 2011
There is a risk that the user may interpret the instructions in the manual too literally, and adjust the TMR 10 dose description to obtain an ETCPD that matches previous clinical prescriptions, which in turn could lead to a prescription dose that deviates a few percent from the intended dose.
- Terminated Z-1134-2010 FDA Unclassified (pre-2012) initiated 23 Oct 2008
Although the co-registration looks good during the verification step in the co-registration dialog, the obtain transformation may include an error that depends on the voxel sizes and acquisition parameters of the co-registered image studies.
- Terminated Z-1604-2010 FDA Unclassified (pre-2012) initiated 7 Jan 2008
The precision of the calculation used to create the fused study in LGP 8.0 is too low and should not be used until the system is upgraded to LGP 8.2.
- Terminated Z-1223-2011 FDA Unclassified (pre-2012) initiated 1 Oct 2005
Investigation found that if a user accidentally selects the wrong image/tube position images can be displayed flipped.

1 jurisdiction

United States — FDA 510(k) Active

510(k)