# K032633: HRK-63-8 Knee Array Coil

- Pathway: 510(k) (Special)
- Applicant: Mri Devices Corp.
- Decided: Sep 25, 2003 after 30 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.
25 later devices descend from it; 3 cite it directly.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- 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
- K152283: MAGNETOM Amira (2015), 9 descendants of its own
- K173600: MAGNETOM Amira (2017), 7 descendants of its own

## Indications for use
To be used in conjunction with a Magnetic Resonance Scanner to produce diagnostic can be interpreted by a trained physician.

Source page: https://510kreport.com/device/K032633
Methodology: https://510kreport.com/methodology