# K943440: Profile 7000 C-Spine Coil

- Pathway: 510(k) (Traditional)
- Applicant: Us Asia Instruments, Inc.
- Decided: Oct 6, 1995 after 445 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
No predicates in its family tree.
30 later devices descend from it; 3 cite it directly.
0 of 31 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K971246: Leo 7000 Quadrature Knee Coil (1997), 26 descendants of its own
- K023982: Leo Iii TX/RX Quadrature Knee Coil; Alpha Iii TX/RX Quadrature Wrist Coil (2003), 22 descendants of its own
- K082636: TXRX 15CH Knee Coil (1.5T and 3T), TXRX CP Extremity Coil 3T (2008), 21 descendants of its own
- K100141: 14-Channel Extremity Coil for Magnetom Essenza (2010), 12 descendants of its own
- K130262: Magnetom Essenza with Syngo MR D14 (2013), 11 descendants of its own

Source page: https://510kreport.com/device/K943440
Methodology: https://510kreport.com/methodology