# K121545: Bellyboard, SBRT Accessories

- Pathway: 510(k) (Traditional)
- Applicant: Medtec Inc. Dba Civco Medical Solutions
- Decided: Jun 8, 2012 after 14 days
- Product code: LNH (System, Nuclear Magnetic Resonance Imaging)
- Device class: 2
- Regulation: 21 CFR 892.1000
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K905007 (1991). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060737: Sinmed Positioning Devices, Sinmed BV (2006) Summary page 1.
- K973842: Carbon Fiber Conformal Couch Top, Medtec, Inc. (1997) Summary page 1.

## Recalls of this device
- Oct 25, 2013 · Class II · Z-0802-2014: Scales adhered to the product may be misaligned from the zero reference such that one side will not match the other.
- Oct 25, 2013 · Class II · Z-0803-2014: Scales adhered to the product may be misaligned from the zero reference such that one side will not match the other.

## 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/K121545
Methodology: https://510kreport.com/methodology