# K172706: GammaPod - Model A

- Pathway: 510(k) (Traditional)
- Applicant: Xcision Medical Systems, LLC
- Decided: Dec 22, 2017 after 106 days
- Product code: IWB (System, Radiation Therapy, Radionuclide)
- Device class: 2
- Regulation: 21 CFR 892.5750
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K970647 (1997). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060314: Rotating Gamma System.  Gamma Art-6000, American Radiosurgery, Inc. (2006) Summary page 4.

## Most influential descendants
- K180571: GammaPod (2018), 0 descendants of its own

## 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

## 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/K172706
Methodology: https://510kreport.com/methodology