# K960497: Flexible Phased Array Spine Coil

- Pathway: 510(k) (Traditional)
- Applicant: Philips Medical Systems (Cleveland), Inc.
- Decided: Jul 5, 1996 after 154 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: 1 generation back to K893619 (1989). 2 ancestors in all.
39 later devices descend from it; 5 cite it directly.
0 of 42 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K893619: Vista MR 2055 HP System, Philips Medical Systems (Cleveland), Inc. (1989) Summary page 2.
- K945827: Outlook, Philips Medical Systems (Cleveland), Inc. (1995) Summary page 2.

## 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

## Indications for use
The Flexible Phased Array Spine Coil is designed to provide coverage of the thoracic and lumbar spinal regions of the body. The indications for use are the same as for standard MR imaging.

Source page: https://510kreport.com/device/K960497
Methodology: https://510kreport.com/methodology