# K180021: Proton Positioing and Immobilization Devices

- Pathway: 510(k) (Traditional)
- Applicant: Medtec Inc Dba Civco Medical Solutions and Civco Radiotherap
- Decided: Jun 29, 2018 after 177 days
- Product code: IYE (Accelerator, Linear, Medical)
- Device class: 2
- Regulation: 21 CFR 892.5050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K973842 (1997). 1 ancestor in all.
5 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K973842: Carbon Fiber Conformal Couch Top, Medtec, Inc. (1997) Summary page 4.

## Most influential descendants
- K212909: VacuumCushions, FeetSupports, LEPS (Lower Extermities Positioning System), CouchStrips (2022), 2 descendants of its own
- K222977: DSPS-Prominent™ Masks; DSPS-Prominent™ Baseplate, MR; CouchStrip (2023), 1 descendant of its own
- K211001: C-Qual M™ Breastboard; Monarch™ Overhead Arm Positioner (2021), 1 descendant of its own
- K250429: DSPS-Prominent® baseplate, MR  (113820); DSPS-Prominent® baseplate (113120); DSPS-Prominent® Cradle-I  (113140); DSPS-Prominent® Cradle-II  (113150); DSPS-Prominent® Cradle-III (113160); DSPS-Prominent® Cradle-IV (113170); DSPS-Prominent® Cradle-VI (113180); DSPS-Prominent® Cradle-VII (113260); Mask DSPS®-PROSCVRL set/5 (113760); Mask DSPS®-PROSC set/5 (113770); Mask DSPS®-PROSCVR set/5 (113780); Mask DSPS®-PROSCL set/5 (113790); Mask DSPS®-PROSHVRL set/5 (113890); Mask DSPS®-PROSH set (2025), 0 descendants of its own
- K213439: FlexBoardTM, EagleBoardTM, BreastBoard SXTM (2022), 0 descendants of its own

## Indications for use
General Positioning Devices: The device is indicated to aid in supporting and positioning adult and pediatric patients undergoing radiation therapy including electron, photon, and proton treatments. The device is also used during image acquisition to support treatment planning. Devices include Couchtops, Lok‐Bars, Extensions, Cushions, and Accessories. The following are other positioning devices: Head, Neck, and Shoulders Devices: The device is indicated to aid in supporting, positioning, and/or immobilization of adult and pediatric patients undergoing radiation therapy of the head, brain, neck, and spine including radiosurgery and electron, photon, and proton treatments. The device is also used during image acquisition to support treatment planning. Devices include Overlays, Extensions, Thermoplastic Masks, and Cushions. Support Garments: The device is indicated to aid in supporting adolescent and adult patients undergoing radiation therapy including electron, photon, and proton treatments. The device is also used during image acquisition to support treatment planning. The device is not intended for use with patients under 12 years of age. Breast Positioning Devices: The device is indicated to aid in supporting and positioning adult and adolescent patients undergoing radiation therapy of the breast and chest region including electron, photon, and proton treatments. The device is also used during image acquisition to support treatment planning. The device is not intended for use with patients under 12 years of age.

Source page: https://510kreport.com/device/K180021
Methodology: https://510kreport.com/methodology