# K111340: Head and Neck Immobilization System, Body Immobilization System

- Pathway: 510(k) (Traditional)
- Applicant: Medtec, Inc.
- Decided: Jun 28, 2011 after 47 days
- Product code: LNH (System, Nuclear Magnetic Resonance Imaging)
- Device class: 2
- Regulation: 21 CFR 892.1000
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K905007 (1991). 16 ancestors in all.
13 later devices descend from it; 3 cite it directly.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080072: Mri Patient Positioning Devices, CIVCO Medical Instruments Co., Inc. (2008) Summary page 2.
- K093738: Mri Patient Positioning Devices, Medtec, Inc. (2010) Summary page 2.
- K954225: Med-Tec Hand Grip, Medtec, Inc. (1995) Summary page 2.

## Cited in the summary but kept off the family tree
- K972842: Interpore Inducer Bone Graft Delivery Syringe, Interpore Intl. (1997). Our reading of the summary gave K972842, FDA’s number for Interpore Inducer Bone Graft Delivery Syringe (Interpore Intl.). Its FDA name has none of the distinctive words the summary uses for the device it names, “CIVCO Patient Positioning Devices”. Kept off the family tree. Summary page 2.
- K935000: CIVCO Patient Positioning Devices. Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 2.

## Most influential descendants
- 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
- 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

## Indications for use
CIVCO Patient Positioning Devices are used to aid in the support and positioning of patients during MR, radiological, and other procedures.

Source page: https://510kreport.com/device/K111340
Methodology: https://510kreport.com/methodology