(73 days)
Not Found
No
The device description focuses solely on the physical construction and materials of an MRI coil. There is no mention of software, algorithms, image processing, or any terms related to AI/ML.
No.
The device is described for "Imaging" and is a "Flexible Small Parts coil," indicating its function is for acquiring images, not for treating conditions.
Yes
The device is an MRI coil used for imaging various parts of the body, and its intended use explicitly mentions "Imaging of" many anatomical sites, including MRCP, MR Urography, MR Myelography, and MR Angiography, all of which are diagnostic imaging techniques. Furthermore, it explicitly states a predicate device is a "diagnostic resonance system."
No
The device description explicitly details hardware components like a flexible coil winding, tune box, clamp, copper strip, foam, and PIN diodes. This indicates it is a physical medical device, not software-only.
Based on the provided information, 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, tissue) to provide information about a person's health. This testing is done outside the body (in vitro).
- Device Function: The description clearly states the device is a "Flexible Small Parts coil" used for "Imaging of... The Whole Body". It's a component of a Magnetic Resonance (MR) system, which is an imaging modality that works by using magnetic fields and radio waves to create images of the inside of the body.
- Intended Use: The intended use is for imaging various anatomical sites within the body, not for analyzing samples taken from the body.
- No Mention of Specimens: There is no mention of the device being used with or analyzing any type of biological specimen.
Therefore, the device described is an in vivo diagnostic imaging device, 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, small parts which include: wrist, elbow, ankle, shoulder, hand, knee). [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 Flexible Small Parts coil is comprised of a flexible coil winding, tune box, and clamp. The flexible coil winding is fabricated from a single strip of copper and encased in soft closed cell foam. The winding conforms to the irregular surface of anatomy and keeps the shape it is formed to while the foam provides consistent spacing between the windings and anatomy.
Decoupling is dual active and achieved with PIN diodes. The impedance of the coil is 50 ohms nominal and it is a solenoid type coil.
The Flexible Small Parts 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; The Whole Body (including head, abdomen, breast, pelvis, limbs and extremities, spine, neck, TMJ, heart, blood vessels, small parts which include: wrist, elbow, ankle, shoulder, hand, knee)
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 6 & 7).
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
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 | May 19, 1999 |
| 6. DEVICE DESCRIPTION | The Flexible Small Parts coil is comprised of a flexible coil winding, tune box, and clamp. The flexible coil winding is fabricated from a single strip of copper and encased in soft closed cell foam. The winding conforms to the irregular surface of anatomy and keeps the shape it is formed to while the foam provides consistent spacing between the windings and anatomy. |
Decoupling is dual active and achieved with PIN diodes. The impedance of the coil is 50 ohms nominal and it is a solenoid type coil.
The Flexible Small Parts 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):