(87 days)
No
The description focuses on the physical design and signal processing of the RF coil, with no mention of AI or ML for image analysis or other functions.
No.
The device is described as an imaging device (Magnetic Resonance) used for diagnostic purposes, not for treating diseases or conditions.
Yes
The device is a body coil for Magnetic Resonance (MR) imaging, which is an imaging modality used for diagnostic purposes, as indicated by "Imaging of: The Whole Body" and "Application terms include MRCP (MR Cholangiopancreatography), MR Urography, MR Myelography, MR Fluoroscopy, SAS (Surface Anatomy Scan), Dynamic Scan and Cine Imaging." which are diagnostic procedures. Additionally, a predicate device listed is the "OPART™ diagnostic resonance system."
No
The device description clearly details physical hardware components (coils, traces, connectors) and their function in acquiring MR signals, indicating it is a hardware device, not software-only.
Based on the provided text, 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 that this device is a flexible body coil for Magnetic Resonance (MR) imaging. MR imaging is a non-invasive technique that uses magnetic fields and radio waves to create images of the inside of the body.
- Intended Use: The intended use is for "Imaging of: The Whole Body..." and lists various anatomical sites and imaging applications. This is consistent with an imaging device, not a diagnostic test performed on a sample.
- No Mention of Samples: There is no mention of analyzing biological samples or performing tests on them.
Therefore, this device is an imaging accessory for an MR system, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Imaging of: The Whole Body (including head, abdomen, breast, pelvis, limbs and extremities, spine, neck, TMJ, heart, blood vessels). [Application terms include MRCP (MR Cholangiopancreatography), MR Urography, MR Myelography, MR Fluoroscopy, SAS (Surface Anatomy Scan), Dynamic Scan and Cine Imaging.] Fluid Visualization 2D/3D Imaging. MR Angiography/MR Vascular Imaging
Product codes
90 MOS
Device Description
The Large and Medium Flexible QD Body coils are essentially a QD (quadrature) extension and a flexible version of the standard Body Coil. The extension consists of adding a saddle trace to the existing solenoid trace. The two independent RF traces have RF magnetic fields which are orthogonal (oriented at 90 degrees with respect to each other) to create a quadrature coil. The NMR signals from the two independent loops are sent to an RF front end where they are then amplified and combined (summed) to provide a resultant signal with improved signal-to-noise ratio. With the coil's flexibility. RF connectors are added which enable the coil to open for patient loading. This enables the coil to be placed directly on the patient pallet. The standard body coil requires the patient to lay on the patient pallet then the patient with pallet is slid through the body coil. An advantage of placing the patient directly on the coil is that the pallet does not go through the coil. Hence the pallet is not filling the coil. This enables the coil to be physically smaller, for improved signal to noise, without losing space for patient loading.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance Diagnostic Device
Anatomical Site
Head, body, extremity, spine, neck, TMJ, breast, and heart. The Whole Body (including head, abdomen, breast, pelvis, limbs and extremities, spine, neck, TMJ, heart, blood vessels).
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)
Sample phantom images and clinical images are presented from both the Large Flexible QD Body coil (Appendix D & E) and the Medium Flexible QD Body coil (Add to file appendix 2 and 3).
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
000000 241 1000 1
Kcj9007
510(k) Premarket Notification
SUMMARY OF SAFETY AND EFFECTIVENESS
| 1. | DEVICE NAME: | Magnetic Resonance Diagnostic Device Accessory | ||
|---|---|---|---|---|
| Model Number: | MRT-600 | |||
| Trade/Proprietary Name: | OPART™ | |||
| 2. | ESTABLISHMENT REGISTRATION: | 2636923 | ||
| 3. | U.S. AGENT NAME AND ADDRESS: | Toshiba America MRI, Inc. | ||
| 280 Utah Avenue | ||||
| South San Francisco, CA 94080 | ||||
| CONTACT PERSON: | Ken Nehmer | |||
| (650)872-2722 ext. 6083 |
-
MANUFACTURING SITE: USA Instruments, Inc. 4. 675-B Alpha Drive Highland Heights, Ohio 44143, USA
Establishment Registration: 1529041 -
DATE OF SUBMISSION: December 31, 1998 5.
-
DEVICE DESCRIPTION: The Large and Medium Flexible QD Body coils are essentially a QD 6. (quadrature) extension and a flexible version of the standard Body Coil. The extension consists of adding a saddle trace to the existing solenoid trace. The two independent RF traces have RF magnetic fields which are orthogonal (oriented at 90 degrees with respect to each other) to create a quadrature coil. The NMR signals from the two independent loops are sent to an RF front end where they are then amplified and combined (summed) to provide a resultant signal with improved signal-to-noise ratio.
With the coil's flexibility. RF connectors are added which enable the coil to open for patient loading. This enables the coil to be placed directly on the patient pallet. The standard body coil requires the patient to lay on the patient pallet then the patient with pallet is slid through the body coil. An advantage of placing the patient directly on the coil is that the pallet does not go through the coil. Hence the pallet is not filling the coil. This enables the coil to be physically smaller, for improved signal to noise, without losing space for patient loading.
1
SAFETY PARAMETERS:
| Maximum static field strength: | 0.35 Tesla |
|---|---|
| Rate of change of magnetic field: | 19T/second |
| Maximum radio frequency power deposition (SAR): | ✓ |
| ---------------------- | -------------------------------------------- |
| (Per 21 CFR§801.109) |
OR
| Over-The-Counter Use | |
|---|---|
| (Optional Format 1-2-96) |
| (Division Sign-Off) | |
|---|---|
| Division of Reproductive, Abdominal, ENT, and Radiological Devices |
| 510(k) Number | K990007 |
|---|---|
| --------------- | --------- |
CONFIDENTIAL