# K010946: Mark 9000 Phased Array Shoulder Coil

- Pathway: 510(k) (Traditional)
- Applicant: Usa Instruments, Inc.
- Decided: May 30, 2001 after 62 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.
4 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K042009: Mark Iii Phased Array Shoulder Coil (2004), 2 descendants of its own
- K071611: Neocoil 3.0T 8-Channel Shoulder Array Coil (2007), 1 descendant of its own
- K201101: 1.5T 16ch Shoulder Coil, 3.0T 16ch Shoulder Coil (2020), 0 descendants of its own
- K020268: Isaac 1.5 T MR System (2002), 0 descendants of its own

Source page: https://510kreport.com/device/K010946
Methodology: https://510kreport.com/methodology