(51 days)
Not Found
No
The device description focuses on the physical characteristics and intended use of an enlarged body coil for an existing MRI system. There is no mention of AI, ML, or any software-based image processing that would suggest the use of these technologies.
No
The device is described as a coil for imaging, specifically an "Extra Large Body coil" for use with an "OPART™ system" (Magnetic Resonance imaging system), indicating it's for diagnostic purposes, not therapeutic.
Yes
The "Intended Use / Indications for Use" section explicitly states "Imaging of: -The Whole Body (including head, abdomen, breast, pelvis, limbs and extremities, spine, neck, TMJ, heart, blood vessels)" and lists applications like "MRCP (MR Cholangiopancreatography), MR Urography, MR Myelography, MR Fluoroscopy." These are all diagnostic imaging procedures. Furthermore, the "Predicate Device(s)" mentions "K962933; OPART™ diagnostic resonance system," indicating that the system this coil is part of is diagnostic.
No
The device description explicitly states it is a "coil," which is a hardware component used in Magnetic Resonance imaging systems.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for imaging various parts of the body using Magnetic Resonance (MR). This is a diagnostic imaging technique performed in vivo (within the living body), not in vitro (outside the body, typically on biological samples).
- Device Description: The device is a body coil for an MR system, which is a component used to generate and receive radiofrequency signals for imaging. This aligns with in vivo imaging.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing information about a patient's health status based on in vitro testing.
Therefore, this device is a component of a medical imaging system used for in vivo diagnosis, not an IVD.
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 (comma separated list FDA assigned to the subject device)
90 MOS
Device Description
The Extra Large Body coil is an enlarged version of the current OPART™ Large Body Coil. This coil is an optional coil which was developed to allow positioning of larger sized patients in the OPART™ system. The Extra Large Body coil can be used as a standalone coil, or in conjunction with the T-spine surface coil (cleared with OPART™ system K962933). Signal is received in QD mode when used in conjunction with the T-spine surface coil.
The Extra Large Body Coil is constructed with the same materials that are currently in use for the released coil set for OPART™.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance
Anatomical Site
Head, body, extremity, spine, neck, TMJ, breast, and heart
Imaging of:
- -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 the Extra Large Body coil (Appendix 5 & 6).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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
K99/057
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 | |
| 4. MANUFACTURING SITE: | same as above |
| 5. DATE OF SUBMISSION: | March 29, 1999 |
| 6. DEVICE DESCRIPTION: | The Extra Large Body coil is an enlarged version of the current OPART™ Large Body Coil. This coil is an optional coil which was developed to allow positioning of larger sized patients in the OPART™ system. The Extra Large Body coil can be used as a standalone coil, or in conjunction with the T-spine surface coil (cleared with OPART™ system K962933). Signal is received in QD mode when used in conjunction with the T-spine surface coil. |
| The Extra Large Body Coil is constructed with the same materials that are currently in use for the released coil set for OPART™. | |
| 7. SAFETY PARAMETERS: | |
| Maximum static field strength: | 0.35 Tesla |
| Rate of change of magnetic field: | 19T/second |
| Maximum radio frequency power deposition (SAR): |