# K973441: Leksell Gammaplan

- Pathway: 510(k) (Traditional)
- Applicant: Patterson Consulting Group, Inc.
- Decided: Apr 1, 1998 after 202 days
- Product code: IWB (System, Radiation Therapy, Radionuclide)
- Device class: 2
- Regulation: 21 CFR 892.5750
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K914808 (1992). 1 ancestor in all.
12 later devices descend from it; 4 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K914808: Leksell Gammaplan (LGP), Elekta Instruments, Inc. (1992) Summary page 1.

## Most influential descendants
- K042269: Leksell Gammaplan 4C with Multiview (2004), 11 descendants of its own
- K051022: Gammaplan (2005), 10 descendants of its own
- K061540: Leksell Gammaplan (2006), 9 descendants of its own
- K090972: Leksell Gammaplan (2009), 6 descendants of its own
- K103093: Leksell Gammaplan (2010), 5 descendants of its own

## Recalls of this device
- Jun 23, 2011 · Not classified · Z-0307-2012: 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 
- Oct 23, 2008 · Not classified · Z-1134-2010: 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 param
- Jan 7, 2008 · Not classified · Z-1604-2010: 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.
- Oct 1, 2005 · Not classified · Z-1223-2011: Investigation found that if a user accidentally selects the wrong image/tube position images can be displayed flipped.

## Indications for use
The Leksell GammaPlan (LGP) is designed for use with the Leksell Gamma Knife manufactured by Elekta Instrument, AB. The Leksell GammaPlan is intended to be used for planning the dosimetry of treatments in stereotactic radiosurgery and stereotactic radiation therapy. It processes the inputs of the health care professionals (Neurosurgeons, Radiation Therapists, Radiation Physicists) such that the desired radiation dose is provided by the Leksell Gamma Knife to a precisely defined target area within the cranium.

Source page: https://510kreport.com/device/K973441
Methodology: https://510kreport.com/methodology