# K182079: Solstice SRS Immobilization System; Solstat Immobilization System; Solstice Thermoplastic Mask

- Pathway: 510(k) (Traditional)
- Applicant: Medtec Inc. Dba Civco Medical Solutions
- Decided: Sep 7, 2018 after 36 days
- Product code: IYE (Accelerator, Linear, Medical)
- Device class: 2
- Regulation: 21 CFR 892.5050
- 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: 6 generations back to K935300 (1994). 34 ancestors in all.
No later device cites it as a predicate yet.
0 of 35 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122888: CDR Systems Precision Patient Positioning System, Cdr Systems, Inc. (2013) Summary page 4.

## Recalls of this device
- Apr 15, 2019 · Class II · Z-1837-2019: There is a potential for movement of the Solstice Tilting Head Fixation System during patient setup and/or treatment.

## Indications for use
The device is indicated to position and/or immobilize adult and pediatric patients undergoing radiation therapy of the head, brain, and neck, including Stereotactic Radiosurgery (SRS), Stereotactic Radiotherapy (SRT), Surface Guided Radiation Therapy (SGRT) and electron, photon, and proton treatments. The device is also used during image acquisition, including Computed Tomography (CT), to support treatment planning. The device is indicated to position and/or immobilize adult and pediatric patients undergoing radiation therapy of the head, brain, and neck, including Surface Guided Radiation Therapy (SGRT) and electron, photon, and proton treatments. The device is also used during image acquisition, including Computed Tomography (CT), to support treatment planning. The device is indicated to position and/or immobilize adult and pediatric patients undergoing radiation therapy of the head, brain, and neck, including Surface Guided Radiation Therapy (SGRT) and electron, photon, and proton treatments. The device is also used during image acquisition, including Computed Tomography (CT) Magnetic Resonance (MR) Imaging, to support treatment planning.

Source page: https://510kreport.com/device/K182079
Methodology: https://510kreport.com/methodology