# K180571: GammaPod

- Pathway: 510(k) (Special)
- Applicant: Xcision Medical Systems, LLC
- Decided: Apr 4, 2018 after 30 days
- Product code: IWB (System, Radiation Therapy, Radionuclide)
- Device class: 2
- Regulation: 21 CFR 892.5750
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K970647 (1997). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172706: GammaPod - Model A, Xcision Medical Systems, LLC (2017) Summary page 4.

## Recalls of this device
- Nov 30, 2023 · Class II · Z-0750-2024: Wrong structures imported into the GammaPod Treatment Planning System.-system allowed an RTSS generated from a previous CT scan to be selected
- Jul 3, 2019 · Class II · Z-2081-2019: One bolt on the V motor was not fully tightened which caused a drift of .13 degrees in alignment resulting in reduced dose output.

## Indications for use
GammaPod™ is a teletherapy device intended for use in the noninvasive stereotactic delivery of a radiation dose to a partial volume of the breast in conjunction with breast conserving treatment.

Source page: https://510kreport.com/device/K180571
Methodology: https://510kreport.com/methodology