# K083578: Noras CPC Multifunctional Coil

- Pathway: 510(k) (Abbreviated)
- Applicant: Noras Mri Products GmbH
- Decided: Jan 16, 2009 after 44 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
Longest line of descent: 4 generations back to K971684 (1997). 15 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012491: Machnet Carotids Coil Array Assembly, Machnet BV (2001) Summary page 3.
- K063373: Flex Loop Coil Set 3T, Siemens AG (2006). Our reading of the summary gave K063313, FDA’s number for Filterwire EZ Embolic Protection System (3.5 MM to 5.5 MM) (Boston Scientific Corp). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Siemens Flex Loop Coil Set 3T”.
- K993477: HRW Wrist Array Coil, Mri Devices Corp. (1999) Summary page 3.
- K963356: Phased Array Shoulder Coil, Philips Medical Systems (Cleveland), Inc. (1996) Summary page 3.
- K010074: Model 455GE Phased Array Wrist Coil, Medical Advances, Inc. (2001) Summary page 3.
- K071882: Model CG-WHC18-H150-AP - Wrist Hand Coil 1.5T 4 CH,, Shanghai Chenguang Medical Technologies Co, Ltd. (2007) Summary page 3.

## Most influential descendants
- K140252: 16 CH Multipurpose Coil Variety (2014), 0 descendants of its own

## Indications for use
The intended use of the Noras CPC is, in conjunction with a Magnetic Resonance Scanner, Body-imaging for diagnostic with a MRI system It is indicated for use as a diagnostic imaging device to produce transverse, sagittal, coronal and oblique images of the internal structures of special regions of the human body When interpreted by a trained physician, these images provide information that can be useful in determining diagnosis The application area shouldn't be bigger than 20 cm because of the depth of penetration of 10 cm per coil The outcome of this is diagnostic images of toes, feet, ankle, knee, finger, hand, wrist, elbow, shoulder, carotid artery, inner ear and other parts of the body with similar structure can be taken

Source page: https://510kreport.com/device/K083578
Methodology: https://510kreport.com/methodology