# K033567: Models HRK-63-8 PMS and HRK-127-8 Knee Array Coils

- Pathway: 510(k) (Special)
- Applicant: Mri Devices Corp.
- Decided: Nov 25, 2003 after 15 days
- Product code: MOS (Coil, Magnetic Resonance, Specialty)
- Device class: 2
- Regulation: 21 CFR 892.1000
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 2 cite it directly.
0 of 3 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
- K242879: dS Knee Coil 8ch 1.5T (2024), 0 descendants of its own
- K233600: Smart Fit Knee 3.0T (2024), 0 descendants of its own

## Recalls of this device
- Sep 14, 2020 · Class III · Z-0126-2021: The labels have been mistakenly printed with an IPX1 rating symbol. IPX ratings relate to protections that products have from water ingress.

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

Source page: https://510kreport.com/device/K033567
Methodology: https://510kreport.com/methodology