Who is the manufacturer of FLEXIBLE PHASED ARRAY SPINE COIL?

Philips Medical Systems (Cleveland), Inc. filed the 510(k) submission for FLEXIBLE PHASED ARRAY SPINE COIL (K960497).

What is the FDA product code for FLEXIBLE PHASED ARRAY SPINE COIL?

LNH. It is classified under 21 CFR 892.1000 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for FLEXIBLE PHASED ARRAY SPINE COIL?

510(k) clearance (submission type: Traditional).

What are the predicate devices for FLEXIBLE PHASED ARRAY SPINE COIL?

Picker Extended Coverage Head Coil (K893619); Outlook Body Coil (K945827).

Who can help prepare an FDA 510(k) submission like FLEXIBLE PHASED ARRAY SPINE COIL?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

FLEXIBLE PHASED ARRAY SPINE COIL

K960497 · Philips Medical Systems (Cleveland), Inc. · LNH · Jul 5, 1996 · Radiology

Device Facts

Record ID	K960497
Device Name	FLEXIBLE PHASED ARRAY SPINE COIL
Applicant	Philips Medical Systems (Cleveland), Inc.
Product Code	LNH · Radiology
Decision Date	Jul 5, 1996
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.1000
Device Class	Class 2

Intended Use

The Flexible Phased Array Spine Coil is designed to provide coverage of the thoracic and lumbar spinal regions of the body. The indications for use are the same as for standard MR imaging.

Device Story

Flexible Phased Array Spine Coil; receive-only phased array coil for MRI systems. Input: MR signals from thoracic/lumbar spine. Operation: solenoid and saddle coil elements encased in flexible vinyl; active PIN diode decoupling isolates elements from transmitted RF. Output: MR image data for clinical interpretation. Used in clinical MRI suites; operated by MRI technologists/radiologists. Benefits: flexible design allows wrapping around patient for improved positioning and image coverage. Safety: non-conductive enclosure; does not transmit RF power; SAR algorithm limits power deposition.

Clinical Evidence

Bench testing only. No clinical data provided. Safety and effectiveness established through comparison of design, materials, and operational parameters (decoupling, SAR management) to predicate devices.

Technological Characteristics

Two-channel receive-only phased array coil; solenoid and saddle elements; flexible vinyl enclosure. Active PIN diode decoupling. Energy source: MRI system RF. Connectivity: proprietary interface to MRI system. Sterilization: N/A.

Indications for Use

Indicated for patients requiring MR imaging of the thoracic and lumbar spinal regions.

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

Picker Extended Coverage Head Coil (K893619)
Outlook Body Coil (K945827)

Related Devices

K964753 — MATRIX 3000 FLEXIBLE SPINE COIL · Us Asia Instruments, Inc. · Feb 11, 1997
K031366 — PREMIER 9000 8 CHANNEL PHASED ARRAY CTL SPINE COIL · Usa Instruments, Inc. · Jul 11, 2003
K984159 — MEDRAD QUADRATURE CTL ARRAY COIL · Medrad, Inc. · Jan 12, 1999
K013595 — PREMIER III PHASED ARRAY CTL SPINE COIL · Usa Instruments, Inc. · Jan 22, 2002
K031056 — MODIFICATION TO PREMIER III PHASED ARRAY CTL SPINE COIL · Usa Instruments, Inc. · May 8, 2003

Submission Summary (Full Text)

{0} JUL - 5 1996 SUMMARY OF SAFETY AND EFFECTIVENESS K960497 1. General Information Classification: Class II Magnetic Resonance (MR) Imaging System Common/Usual Name: MRI Receive-Only Coil Proprietary Name: Flexible Phased Array Spine Coil Establishment Registration: Manufacturer: Picker Nordstar, Inc. P.O. Box 33 FIN-0051 Helsinki, FINLAND Phone: +358-0-394 127 Fax: +358-0-146 2811 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 used under section 514 of the Food, Drug and Cosmetic Act. 2. Intended Uses The Flexible Phased Array Spine Coil is designed to provide coverage of the thoracic and lumbar spinal regions of the body. The indications for use are the same as for standard MR imaging. 3. Device Description The Flexible Phased Array Spine Coil is a phased array coil package consisting of a solenoid and a saddle coil element. All elements and associated circuitry are enclosed in a flexible vinyl enclosure. The patient is wrapped with the coil allowing for ease of patient positioning. The coil has a fixed circumference and attaches by snapping the ends together. PICKER INTERNATIONAL, INC. (FPASC) (2/1/96) I-1 {1} # 4. Safety and Effectiveness SUBSTANTIAL EQUIVALENCE CHART | PARAMETER | FLEXIBLE SPINE COIL | PREDICATE | | --- | --- | --- | | Coil Enclosure Material | Vinyl fabric | Same as material uses in Picker Extended Coverage Head Coil (K893619) | | Coil Design | Two-channel receive-only phased array coil | Outlook Body Coil is a receive-only phased array coil (K945827) | | Decoupling | Active PIN diode decoupling | Same as Body Coil for Outlook (K945827) | | Formation of Resonant Loops | The length of the cable and its stiffness does not permit looping. | N/A | | Potential for RF burns | Does not transmit RF power. Coil elements and associated circuitry encased in non-conductive material. Decoupling isolates the coil elements from transmitted RF. | Same as other Outlook Coils (K945827) | | Radio Frequency Absorption | Power deposition during imaging is limited by the SAR algorithm. | Algorithm used on Outlook system (K945827) | | Intended Use | Thoracic and Lumbar spine regions. | Body Coil for Outlook (K945827) | | Indications for Use | Same as for standard MR imaging. | Body Coil for Outlook (K945827) | PICKER INTERNATIONAL, INC. (FPASC) (2/1/96)