Models HRK-63-8 PMS and HRK-127-8 Knee Array Coils

• • Terminated Z-0126-2021 FDA Class III ·initiated 14 Sep 2020

  The labels have been mistakenly printed with an IPX1 rating symbol. IPX ratings relate to protections that products have from water ingress.

510(k) Number

K033567 ↗

FDA Product Code

MOS

Device Class

Class II

Regulation

21 CFR Part 892.1000

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

• Model #sct-32 Auto Quadrature Spine Coil Transport

  Class II

  FDA 510(k) K913441 Active Cleared 21 Oct 1991

• Modification to Hnc-127-Int Neurovascular Array Coil

  Class II

  FDA 510(k) K040348 Active Cleared 9 Mar 2004

• Phsl-63-Sym and Phs-63-Sym Pediatric Head and Spine Array Coils

  Class II

  FDA 510(k) K024354 Active Cleared 9 Jan 2003

• Modification to Hrw-127 Wrist Array Coil

  Class II

  FDA 510(k) K040349 Active Cleared 9 Mar 2004

• Qwh-250-Pan Wrist Array Coil

  Class II

  FDA 510(k) K024209 Active Cleared 9 Jan 2003

• Obc-149 Breast Array Coil

  Class II

  FDA 510(k) K003340 Active Cleared 8 Nov 2000

See all devices from Mri Devices Corp. →

• What are the HRK-63-8 PMS and HRK-127-8 Knee Array Coils designed to improve in MRI imaging of the knee?

  These coils are designed as radiofrequency (RF) receiver coils specifically for detecting MR signals from knee anatomy. By capturing signals with higher sensitivity, they transform the detected data into raw information that the host MR scanner uses for clearer and more detailed image reconstruction of the knee joint.

• Are these coils reusable or single-use, and what does that mean for maintenance in a clinical setting?

  The HRK-63-8 PMS and HRK-127-8 Knee Array Coils are non-sterile and reusable, meaning they are intended for repeated use across multiple patients. However, since they are reusable, proper cleaning, disinfection, and maintenance protocols must be followed to ensure hygiene and functionality between uses, as outlined by your facility’s infection control policies.

• What types of MRI scanners are these coils compatible with, and how are they supplied?

  These coils are accessory devices for Magnetic Resonance (MR) scanners and function as RF receiver coils to enhance knee imaging. They are supplied as standalone, reusable components and must be used with a compatible host MR scanner system that supports array coil technology. No additional packaging is required beyond their protective case for storage and transport.

• How do I determine which model (HRK-63-8 PMS or HRK-127-8) is best suited for my imaging needs?

  The distinction between the HRK-63-8 PMS and HRK-127-8 models is not explicitly detailed in the provided data, but the naming convention suggests potential differences in coil design or field strength compatibility (e.g., 63 MHz vs. 127 MHz). Consult your MR scanner’s technical specifications or manufacturer guidelines to ensure compatibility with your system’s operating frequency. For clinical selection, consider factors like field strength, coil size, and intended imaging resolution for knee anatomy.