(82 days)
Not Found
No
The summary describes a physical coil for MR imaging and does not mention any software or processing capabilities, let alone AI/ML.
No.
The device is a coil for an MR imaging system, used for diagnostic imaging rather than therapy. Its intended use is the same as for standard MR imaging, which is a diagnostic procedure.
No
The device is a coil for an MR imaging system, which is a tool used in the diagnostic process but does not itself provide a diagnosis. Its function is to acquire images, not to interpret them or determine a medical condition.
No
The device description explicitly states it is a "Phased Array Neck Coil" consisting of "two coil elements" and "associated circuitry" covered by "ABS and polycarbonate enclosures," indicating it is a physical hardware component for an MR imaging system.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states the device is a "Phased Array Neck Coil" used in conjunction with an "MR Imaging System." Its purpose is to provide coverage of the neck region for standard MR imaging.
- Lack of Biological Sample Analysis: There is no mention of the device analyzing biological samples or performing any tests on materials taken from the body. Its function is to facilitate the acquisition of images using magnetic resonance technology.
Therefore, the Phased Array Neck Coil is a medical device used for imaging, not an in vitro diagnostic device.
N/A
Intended Use / Indications for 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.
Product codes
Not Found
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance (MR) Imaging System
Anatomical Site
Neck, from the cerebellum to the upper thoracic spine region.
Indicated Patient Age Range
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Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 892.1000 Magnetic resonance diagnostic device.
(a)
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).(b)
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.
0
SUMMARY OF SAFETY AND EFFECTIVENESS
(As required by 21 CFR 807.92)
1. General Information
FEB | | 1997 78
Classification: Class II Magnetic Resonance (MR) Imaging System
Common/Usual Name: MRI Receive-Only Coil
Phased Array Neck Coil Proprietary Name:
Establishment Registration
Manufacturer:
Picker Nordstar, Inc. P.O. Box 33 FIN-00511 Helsinki, FINLAND Phone: +358-9-394 127 +358-9-146 2811 Fax: 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
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.
Safety and Effectiveness 4.
| 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. |
SUBSTANTIAL EQUIVALENCE CHART
PICKER INTERNATIONAL, INC.
(PANC)
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 physcian, MR images yield
useful diagnostic information. |