(14 days)
Not Found
No
The device description focuses on the hardware components (coil element, PC board) and their function in transmitting and receiving RF signals for MRI. There is no mention of software, algorithms, or data processing that would suggest the use of AI/ML. The "Mentions AI, DNN, or ML" and "Mentions image processing" sections are explicitly marked as "Not Found".
No
The device is described as a coil used for diagnostic imaging, specifically to transmit RF and receive NMR signals for visualizing anatomical regions. It does not mention any therapeutic function or intent to treat a disease.
Yes
The "Intended Use / Indications for Use" section explicitly states "Diagnostic imaging of the knee, ankle and foot regions" as a primary function of the device.
No
The device description explicitly states it is comprised of a coil element and PC board, which are hardware components.
No, 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. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The provided description clearly states that this device is a coil used for Magnetic Resonance (MR) imaging. It transmits and receives RF signals to create images of anatomical structures within the body (knee, ankle, foot).
- No Sample Analysis: The device does not analyze any biological samples taken from the patient. It interacts directly with the patient's body to generate images.
Therefore, based on the provided information, the QD KNEE/FOOT COIL is a component of an MR imaging system, which is a medical imaging device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Imaging of:
- Diagnostic imaging of the knee, ankle and foot regions
- Fluid visualization
- 2D and 3D imaging .
- MR angiography .
- MR fluoroscopy .
Product codes (comma separated list FDA assigned to the subject device)
MOS
Device Description
The QD KNEE/FOOT COIL is QD volume coil that can transmit RF and receive NMR signal from like the knee or other extremity regions.
The QD KNEE/FOOT COll. is comprised of coil element and PC board. The coil element shapes STIR type coil. The PC board switches transmit mode and receive mode with PIN diodes and combines the NMR signals.
The QD KNEE/FOOT COIL is constructed with the same materials that are currently in use for the released QD KNEE COIL.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance
Anatomical Site
Knee, ankle and foot regions
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 in Appendix F & G.
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
JUL 1 4 2005
1051763
Appendix A
510 (k) SUMMARY OF SAFETY AND EFFECTIVENESS
- DEVICE NAME 1. Magnetic Resonance Diagnostic Device Accessory Model Number MJQJ-147A Trade/Proprietary Name QD KNEE/FOOT COIL™
-
- ESTABLISHMENT REGISTRATION 2020563
-
- U.S. AGENT NAME AND ADDRESS Toshiba America Medical Systems, Inc. (TAMS) 2441 Michelle DriveTustin, CA 92780
CONTACT PERSON
Michaela Mahl (714) 730-5000
MANUFACTURING SITE 4.
Toshiba Medical Systems Corporation (TMSC) 1385, Shimoishigami, Otawara-Shi, Tochigi 324-8550, Japan
5. DATE OF SUBMISSION
June 16, 2005
6. DEVICE DESCRIPTION
The QD KNEE/FOOT COIL is QD volume coil that can transmit RF and receive NMR signal from like the knee or other extremity regions.
The QD KNEE/FOOT COll. is comprised of coil element and PC board. The coil element shapes STIR type coil. The PC board switches transmit mode and receive mode with PIN diodes and combines the NMR signals.
The QD KNEE/FOOT COIL is constructed with the same materials that are currently in use for the released QD KNEE COIL.
7. SAFETY PARAMETERS
Maximum static field strength Rate of change of magnetic field Maximum radio frequency power deposition (SAR) Acoustic noise levels (maximum)
1.5 Tesla 30 mT/second