(88 days)
No
The summary describes a passive RF coil for MRI, with no mention of software, algorithms, or any AI/ML related terms.
No
The device is described as a receive-only RF coil used for obtaining diagnostic images, which is not a therapeutic purpose. It is indicated for use with standard MRI imaging, which is a diagnostic tool.
Yes
The device is described as "used for obtaining diagnostic images," which directly indicates its role as a diagnostic device.
No
The device description explicitly states it is a "receive-only quadrature RF coil" consisting of "two volume RF coil elements and circuitry enclosed in a durable covering," which are physical hardware components.
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 "receive-only quadrature RF coil, used for obtaining diagnostic images of the elbow anatomy in Magnetic Resonance Imaging systems." This is a component used within an imaging system to acquire images of the body, not to analyze samples taken from the body.
- Intended Use: The intended use is for "obtaining diagnostic images," which is a function of medical imaging, not in vitro testing.
Therefore, the Quadrature Extremity Coil is a medical device used for imaging, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Quadrature Extremity Coil is a receive-only quadrature RF coil, used for obtaining diagnostic images of the elbow anatomy in Magnetic Resonance Imaging systems. The indications for use are the same as for standard MR Imaging. The Quadrature Extremity Coil is designed for use with GE Signa (1.5 Tesla) MRI scanner manufactured by GE Medical Systems.
Product codes
Not Found
Device Description
The Quadrature Extremity Coil consists of two volume RF coil elements in a quadrature design. The elements and circuitry are enclosed in a durable covering made of vinyl naughahyde which is fire rated.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance Imaging
Anatomical Site
elbow anatomy
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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.
0
SUMMARY OF SAFETY AND EFFECTIVENESS
FEB 2 8 1997
Comments of cases of program Microsoft
| 1. Device Name : | Magnetic Resonance Imaging Accessory |
|---|---|
| 2. Proprietary Name : | Maxim 7000 Quadrature Extremity 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 Quadrature Extremity Coil is a receive-only |
| quadrature RF coil, used for obtaining diagnostic images | |
| of the elbow anatomy in Magnetic Resonance Imaging | |
| systems. The indications for use are the same as for | |
| standard MR Imaging. The Quadrature Extremity Coil is | |
| designed for use with GE Signa (1.5 Tesla) MRI scanner | |
| manufactured by GE Medical Systems. | |
| 8. Device Description: | The Quadrature Extremity Coil consists of two |
| volume RF coil elements in a quadrature design. The | |
| elements and circuitry are enclosed in a durable | |
| covering made of vinyl naughahyde which is fire rated. |
please turn over
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1
9. Safety and Effectiveness
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| Parameter | Quadrature Elbow
Coil | Predicate |
|----------------------------|-----------------------------------------------------------------------|---------------------------------------------------------------------------------|
| Intended Use | Elbow Imaging Applications | General Purpose Flex Coil
(K944469) marketed by
Picker International |
| Indications for Use | Identical to routine MRI imaging | General Purpose Flex Coil
(K944469) marketed by
Picker International |
| Coil Enclosure Material | Vinyl Fabric | Flexible Spine Coil
(K960497) marketed by
Picker International |
| Coil Design | Quadrature design | Profile 7000 C-spine Coil
(K943440) marketed by US
Asia Instruments. Inc. |
| Decoupling | Switching Diode decoupling | Profile 7000 C-spine Coil
(K943440) marketed by US
Asia Instruments. Inc. |
| Prevention of RF Burns | Does not transmit RF Power | Profile 7000 C-spine Coil
(K943440) marketed by US
Asia Instruments. Inc. |
| | Decoupling isolates the coil elements from RF during RF transmission | |
| | Coil elements and circuitry is enclosed in a non-conductive material. | |
| Radio Frequency Absorption | Coil is a receive only coil and does not transmit RF | Profile 7000 C-spine Coil
(K943440) marketed by US
Asia Instruments. Inc. |
| Formation of Resonant Loop | Decoupling isolates the coil elements from RF during RF transmission | Profile 7000 C-spine Coil
(K943440) marketed by US
Asia Instruments. Inc. |
| | Length of cable and stiffness does not permit looping | |
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