(76 days)
No
The summary describes a physical RF coil for MRI and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
No
The device is described as a "receive-only phased array RF coil, used for obtaining diagnostic images" for MRI, which indicates its purpose is for diagnosis, not therapy.
Yes
The product description explicitly states its use "for obtaining diagnostic images."
No
The device description clearly states it is a physical RF coil with elements, circuitry, and an enclosure, indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Function: The Flexible Spine Coil is a component of an MRI system. Its function is to receive radiofrequency signals from the patient's body during an MRI scan to create diagnostic images. It does not analyze or process biological specimens.
- Intended Use: The intended use is to obtain diagnostic images of the spine, not to perform tests on samples taken from the patient.
Therefore, based on the provided information, the Flexible Spine Coil is a medical device used in imaging, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Flexible Spine Coil is a receive-only phased array RF coil, used for obtaining diagnostic images of the thoracic and lumbar spine in Magnetic Resonance Imaging systems. The indications for use are the same as for standard MR Imaging. The Matrix 3000 Flexible Spine Coil is designed for use with the Outlook (0.23Tesla) MRI scanner manufactured by Picker International Inc.
Product codes
Not Found
Device Description
The Flexible Spine Coil consists of two volume RF coil elements in a quadrature design. The elements and associated circuitry are enclosed in a flexible vinyl enclosure housing. The coil is wrapped around the patient and the ends are connected and locked. The coil has a fixed circumference.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance Imaging
Anatomical Site
Thoracic and Lumbar Spine
Indicated Patient Age Range
Not Found
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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SUMMARY OF SAFETY AND EFFECTIVENESS
1
SUMMARY OF SAFETY AND EFFECTIVENESS
| 1. Device Name : | Magnetic Resonance Imaging Accessory | |
|---|---|---|
| 2. Proprietary Name : | Matrix 3000 Flexible Spine Coil | |
| 3. Classification : | Class II | |
| 4. Establishment Registration #: | 1529041 | |
| 5. Manufacture Facility Location: | USA Instruments, Inc., 675-B Alpha Drive, | |
| Highland Heights, Ohio 44143, USA | ||
| Telephone: 216-442-5920; Fax: 216-442-5919. | ||
| 6. Performance Standard: | No applicable performance standards have been issued | |
| under Section 514 of the Food, Drug and Cosmetic Act. | ||
| 7. Intended Use: | The Flexible Spine Coil is a receive-only phased array RF | |
| coil, used for obtaining diagnostic images of the thoracic | ||
| and lumbar spine in Magnetic Resonance Imaging | ||
| systems. The indications for use are the same as for | ||
| standard MR Imaging. The Matrix 3000 Flexible Spine | ||
| Coil is designed for use with the Outlook (0.23Tesla) | ||
| MRI scanner manufactured by Picker International Inc. | ||
| 8. Device Description : | The Flexible Spine Coil consists of two volume RF coil | |
| elements in a quadrature design. The elements and | ||
| associated circuitry are enclosed in a flexible vinyl | ||
| enclosure housing. The coil is wrapped around the patient | ||
| and the ends are connected and locked. The coil has a | ||
| fixed circumference. |
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9. Safety and Effectiveness
| Parameter | Matrix 3000 Flexible Spine
Coil | Predicate |
|----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Thoracic and Lumbar Spine
Imaging Applications | Flexible Phased Array Spine Coil
Picker International
(K960497) |
| Indications for Use | Identical to routine MRI
imaging | Flexible Phased Array Spine Coil
Picker International
(K960497)
Profile 7000 C-Spine Coils
US ASIA Instruments, Inc.
(K943440) |
| Coil Enclosure Material | Vinyl Fabric | Flexible Phased Array Spine Coil
Picker International
(K960497) |
| Coil Design | Two channel receive-only phased
array coil | Flexible Phased Array Spine Coil
Picker International
(K960497) |
| Decoupling | Switching Diode decoupling | Flexible Phased Array Spine Coil
Picker International
(K960497)
Profile 7000 C-Spine Coils
(K943440), US ASIA
Instruments, Inc. |
| Prevention of RF Burns | Does not transmit RF Power
Decoupling isolates the coil
elements from RF fields during
RF transmission
Coil elements and circuitry
are enclosed in a non-conductive
housing. | Profile 7000 C-Spine Coils
(K943440), US ASIA
Instruments, Inc.
Flexible Phased Array Spine Coil
Picker International
(K960497)
Same as other Outlook Coils
Picker International
(K945827) |
| Radio Frequency Absorption | Coil is a receive only coil and
does not transmit RF power.
Power deposition during imaging
is limited by SAR algorithm | Profile 7000 C-Spine Coils
(K943440), US ASIA
Instruments, Inc.
Algorithm used on Outlook
system (K945827) |
| Formation of Resonant Loop | Decoupling isolates the coil
elements from RF fields during
RF transmission
Length of cable and stiffness
does not permit looping | Profile 7000 C-Spine Coils
(K943440), US ASIA
Instruments, Inc.
Flexible Phased Array Spine Coil
Picker International
(K960497) |