(28 days)
Not Found
No
The summary describes a standard MRI head coil and does not mention any AI or ML components or functionalities.
No
The device is described as a head coil for an MRI system used to produce diagnostic images, not to treat any condition.
No.
Explanation: The device is a head coil for an MRI system, which produces diagnostic images, but is not itself the diagnostic device that interprets the images or provides a diagnosis. It is a component used in the diagnostic process.
No
The device is a physical head coil for an MRI system, which is a hardware component.
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.
- Device Function: The Toshiba 1.5T QD Head Coil is a component of an MRI system. Its purpose is to receive the radiofrequency signals emitted by the patient's head during an MRI scan. These signals are then processed by the MRI system to create diagnostic images.
- Intended Use: The intended use clearly states it's for "producing diagnostic images of the head anatomy." This is an in vivo (within the living body) diagnostic process, not an in vitro one.
- No Sample Analysis: The device does not analyze any samples taken from the patient. It interacts directly with the patient's body.
Therefore, based on the provided information, the Toshiba 1.5T QD Head Coil is a medical device used for in vivo diagnostic imaging, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Toshiba 1.5T QD Head Coil (MJQH-147A) is intended for use with a 1.5T Vantage Titan MRI system to produce diagnostic images of the head anatomy that can be interpreted by a trained physician.
Product codes (comma separated list FDA assigned to the subject device)
MOS
Device Description
The Toshiba 1.5T QD Head Coil is designed for use with the Toshiba Vantage Titan 1.5T MRI system manufactured by Toshiba Medical Systems Corporation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
MRI
Anatomical Site
head anatomy
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained physician
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)
The Toshiba 1.5T QD Head Coil was tested to and found complaint with IEC 60601-1, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (200 Edition) and IEC 60601-1, Medical electrical equipment -Part 1: General requirements for basic safety and essential performance (300 Edition). The coil SAR complies with the requirements of IEC 60601-2-33, Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis (36 Edition).
The signal-to-noise ratio (SNR) was measured according to NEMA MS-1 2008, Determination of Signal-to-Noise Ratio (SNR) in Diagnostic Magnetic Resonance Imaging. The image uniformity was measured according to NEMA MS-3 2008, Determination of Image Uniformity in Diagnostic Resonance Imaging.
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
SUMMARY OF SAFETY AND EFFECTIVENESS 510(k)
1. Applicant
Quality Electrodynamics (QED) 700 Beta Drive, Suite 100 Mayfield Village, OH 44143 Phone (440) 484-2228
2. Contact
Christie Zydyk, MBA Chief Quality and Regulatory Affairs Officer
3. Date prepared:
February 29th, 2012
4. Tradename
Toshiba 1.5T QD Head Coil
5. Common name
Coil, magnetic resonance, specialty
6. Classification -
21 CFR 892.1000
7. Equivalent Device
| Trade name | Legally marketed predicate device | Manufacturer |
|---|---|---|
| Toshiba 1.5T QD Head Coil | Siemens 1.5T/3T CP Head Coil | Quality Electrodynamics |
8. Device Description
The Toshiba 1.5T QD Head Coil is designed for use with the Toshiba Vantage Titan 1.5T MRI system manufactured by Toshiba Medical Systems Corporation.
MAR 2 9 2012
KI20627
1
SUMMARY OF SAFETY AND EFFECTIVENESS 510(k)
9. Indications for Use
The Toshiba 1.5T QD Head Coil (MJQH-147A) is intended for use with a 1.5T Vantage Titan MRI system to produce diagnostic images of the head anatomy that can be interpreted by a trained physician.
10. Comparison with Predicate Devices
| 510(k) # | Legally marketed predicate
device | Manufacturer |
|----------|--------------------------------------|-------------------------|
| K091114 | Siemens 1.5T/3T CP Head Coil | Quality Electrodynamics |
The Toshiba 1.5T QD Head Coil and the predicate device have the same intended use, are of the same design, and are constructed of the same materials.
11.Non-Clinical Tests
The Toshiba 1.5T QD Head Coil was tested to and found complaint with IEC 60601-1, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (200 Edition) and IEC 60601-1, Medical electrical equipment -Part 1: General requirements for basic safety and essential performance (300 Edition). The coil SAR complies with the requirements of IEC 60601-2-33, Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis (36 Edition).
The signal-to-noise ratio (SNR) was measured according to NEMA MS-1 2008, Determination of Signal-to-Noise Ratio (SNR) in Diagnostic Magnetic Resonance Imaging. The image uniformity was measured according to NEMA MS-3 2008, Determination of Image Uniformity in Diagnostic Resonance Imaging.
12. Conclusion
It is the opinion of Quality Electrodynamics that the Toshiba 1.5T QD Head Coil is substantially equivalent to the above-listed legally marketed predicate device. Use of the Quality Electrodynamics coil does not result in any new potential hazards. T
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Ms. Christie Zydyk Chief Quality and Regulatory Affairs Officer Quality Electrodynamics 700 Beta Drive, Suite 100 MAYFIELD VILLAGE OH 44143
MAR 2 9 2012
Re: K120627
Trade/Device Name: Toshiba 1.5T QD Head Coil Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: MOS Dated: March 23, 2012 Received: March 26, 2012
Dear Ms. Zydyk:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of
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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely Yours,
Janine M. Morris
Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
4
K120627
Indications for Use
510(k) Number (if known):
Device Name: Toshiba 1.5T QD Head Coil
Indications for Use:
The Toshiba 1.5T QD Head Coil (MJQH-147A) is intended for use with a 1.5T Vantage Titan MRI system to produce diagnostic images of the head anatomy that can be interpreted by a trained physician.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
gagurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Division Sign-Off Office of In Vitto Diagnostic Device Evaluation and Safety
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