# K222977: DSPS-Prominent™ Masks; DSPS-Prominent™ Baseplate, MR; CouchStrip

- Pathway: 510(k) (Traditional)
- Applicant: Macromedics BV
- Decided: Feb 17, 2023 after 142 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: 7 generations back to K905007 (1991). 20 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142420: Patient Positioning Devices, Macromedics BV (2015) Summary page 5.
- K212909: VacuumCushions, FeetSupports, LEPS (Lower Extermities Positioning System), CouchStrips, Macromedics BV (2022) Summary page 5.

## Most influential descendants
- 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

## Indications for use
DSPS-Prominent Masks, DSPS-Prominent Baseplate, MR: Positioning and immobilization of the patient during radiotherapy. This includes positioning and immobilization of the patient during image acquisition to support treatment, such as in Magnetic Resonance (MR) and Computed Tomography (CT) Imaging Systems. CouchStrip: Positioning of the patient during radiotherapy and radio diagnostics, including MR where indicated.

Source page: https://510kreport.com/device/K222977
Methodology: https://510kreport.com/methodology