# K080072: Mri Patient Positioning Devices

- Pathway: 510(k) (Traditional)
- Applicant: CIVCO Medical Instruments Co., Inc.
- Decided: Jun 4, 2008 after 145 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 K933227 (1994). 5 ancestors in all.
15 later devices descend from it; 3 cite it directly.
0 of 21 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 1.
- K951808: Med-Tec Redi-Foam, Medtec, Inc. (1995) Summary page 1.
- K982624: Moldcare Head & Neck Cushion, Model # MT-Acl-14242, Med-Tec,Inc. (1998) Summary page 1.
- K933227: Uni-Frame Head Immobilization System, Medtec, Inc. (1994) Summary page 1.
- K935300: Vac-Lok Immobilization System, Medtec, Inc. (1994) Summary page 1.

## Most influential descendants
- K093738: Mri Patient Positioning Devices (2010), 14 descendants of its own
- K111340: Head and Neck Immobilization System, Body Immobilization System (2011), 13 descendants of its own
- K142420: Patient Positioning Devices (2015), 7 descendants of its own
- K122888: CDR Systems Precision Patient Positioning System (2013), 5 descendants of its own
- K153026: Body Pro-Lok Respiratory Plate, Respiratory Plate Cushion, Body Pro-Respiratory Belt, Rail Clamp for Respiratory Belt, Pressure Gauge Replacement (2016), 3 descendants of its own

## Indications for use
Patient Positioning Devices are used to aid in the support and positioning of patients during an MRI.

Source page: https://510kreport.com/device/K080072
Methodology: https://510kreport.com/methodology