PHASED ARRAY NECK COIL

K964678 · Philips Medical Systems (Cleveland), Inc. · MOS · Feb 11, 1997 · Radiology

Device Facts

• Record ID: K964678
• Device Name: PHASED ARRAY NECK COIL
• Applicant: Philips Medical Systems (Cleveland), Inc.
• Product Code: MOS · Radiology
• Decision Date: Feb 11, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1000
• Device Class: Class 2

Intended Use

The Phased Array Neck Coil is designed to provide coverage of the neck, from the cerebellum to the upper thoracic spine region. The intended use is the same as for standard MR imaging. The Picker International, Inc. Outlook system which is manufactured by Picker Nordstar, Inc. is intended for use as a NMR device that produces images that: (1) correspond to the distribution of protons exhibiting NMR, (2) depend upon the NMR parameters (proton density, flow velocity, spin-lattice relaxation time (T1), and spin-spin relaxation time (T2)) and (3) display the soft tissue structure of the head and whole body. When interpreted by a trained physician, MR images yield useful diagnostic information.

Device Story

Phased array receive-only coil; two-channel design; captures MR signals from neck region (cerebellum to upper thoracic spine). Used in clinical MR imaging environments; operated by trained MR technologists/radiologists. Device encased in non-conductive ABS and polycarbonate; utilizes active PIN diode decoupling to isolate elements during RF transmission. Output consists of raw MR signal data processed by host MRI system into diagnostic images. Benefits include high-resolution soft tissue visualization of neck anatomy for physician interpretation; aids in clinical diagnosis of head and cervical spine pathologies. Safety features include non-conductive housing, cable design preventing loops, and reliance on host system SAR algorithms to limit RF power deposition.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Two-channel receive-only phased array coil; ABS and polycarbonate enclosures; active PIN diode decoupling; non-conductive construction; cable design prevents resonant loops; passive device (no internal energy source); connects to host MRI system.

Indications for Use

Indicated for MR imaging of the neck region, specifically from the cerebellum to the upper thoracic spine, to provide diagnostic soft tissue images.

Regulatory Classification

Identification

A magnetic resonance diagnostic device is intended for general diagnostic use to present images which reflect the spatial distribution and/or magnetic resonance spectra which reflect frequency and distribution of nuclei exhibiting nuclear magnetic resonance. Other physical parameters derived from the images and/or spectra may also be produced. The device includes hydrogen-1 (proton) imaging, sodium-23 imaging, hydrogen-1 spectroscopy, phosphorus-31 spectroscopy, and chemical shift imaging (preserving simultaneous frequency and spatial information).

Special Controls

*Classification.* Class II (special controls). A magnetic resonance imaging disposable kit intended for use with a magnetic resonance diagnostic device only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.

Predicate Devices

• Vascular Head Coil (K945827)
• Multipurpose size M Coil (K925987)

Submission Summary (Full Text)

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# SUMMARY OF SAFETY AND EFFECTIVENESS
(As required by 21 CFR 807.92)

FEB 11 1997
K964678

## 1. General Information

Classification: Class II
Magnetic Resonance (MR) Imaging System

Common/Usual Name: MRI Receive-Only Coil

Proprietary Name: Phased Array Neck Coil

## Establishment Registration

### Manufacturer:

Picker Nordstar, Inc.
P.O. Box 33
FIN-00511 Helsinki, FINLAND
Phone: [phone]
Fax: [phone]
FDA Facility Registration #9680194

### United States Representative:

Picker International, Inc.
595 Miner Road
Cleveland, OH 44143
FDA Owner Number #1580240

## Performance Standards

No applicable performance standards have been issued under section 514 of the Food, Drug and Cosmetic Act.

## 2. Intended Uses

The Phased Array Neck Coil is designed to provide coverage of the neck, from the cerebellum to the upper thoracic spine region. The intended use is the same as for standard MR imaging.

PICKER INTERNATIONAL, INC.
(PANC)
11/18/96
I - 1

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# 3. Device Description

The Phased Array Neck Coil is a phased array coil consisting of two coil elements. All elements and associated circuitry are covered by ABS and polycarbonate enclosures.

# 4. Safety and Effectiveness

SUBSTANTIAL EQUIVALENCE CHART

| PARAMETER | PHASED ARRAY NECK COIL | PREDICATE DEVICE
Vascular Head Coil (K945827) & Multipurpose size M Coil (K925987) |
| --- | --- | --- |
| Enclosure Material | ABS and Polycarbonate | Polyurethane |
| Coil Design | Same | Two-channel receive-only phased array coil. |
| Decoupling | Same | Active PIN diode decoupling |
| Formation of Resonant Loops | Same | The length of the cable and its stiffness does not permit looping. |
| Potential for RF burns | Same | Does not transmit RF power. |
| | Same | Coil elements and associated circuitry encased in non-conductive material. |
| | Same | Decoupling isolates the coil elements from transmitted RF. |
| Radio Frequency Absorption | Same | Power deposition during imaging is limited by the SAR algorithm. |
| Indications for Use | Neck, from the cerebellum to the upper thoracic spine region. | Head and cervical spine. |

PICKER INTERNATIONAL, INC.
(PANC)
11/18/96

{2}

| Intended Use | Same | The Picker International, Inc. Outlook system which is manufactured by Picker Nordstar, Inc. is intended for use as a NMR device that produces images that: (1) correspond to the distribution of protons exhibiting NMR, (2) depend upon the NMR parameters (proton density, flow velocity, spin-lattice relaxation time (T1), and spin-spin relaxation time (T2)) and (3) display the soft tissue structure of the head and whole body. When interpreted by a trained physician, MR images yield useful diagnostic information. |
| --- | --- | --- |

PICKER INTERNATIONAL, INC.

(PANC)

11/18/96