# K040122: Mayo Clinic BC-10 3.0T

- Pathway: 510(k) (Special)
- Applicant: Mayo Clinic
- Decided: Apr 14, 2004 after 85 days
- Product code: MOS (Coil, Magnetic Resonance, Specialty)
- 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) MRI Devices 1.5T phased array wrist coil: named in the summary without a submission number
- (no number) GE Signa 1.5T birdcage, high-pass, quadrature T/R head coil: named in the summary without a submission number

## Indications for use
The Mayo Clinic BC-10 3.0T wrist coil will be used in conjunction with several commercially available MRI systems to more accurately image a variety of maladies associated with the hand, wrist, forearm, and elbow. Maladies include, but are not limited to, carpal tunnel syndrome, nerve compression, ligament injuries, tendon abnormalities, and scarring. Its 10cm diameter design governs the specific area of the body which can be imaged.

Source page: https://510kreport.com/device/K040122
Methodology: https://510kreport.com/methodology