(14 days)
Not Found
No
The summary describes a hardware component (a receive-only coil) for MRI and does not mention any software or algorithms that would incorporate AI/ML for image processing or interpretation.
No
The device is used for obtaining diagnostic images, which assist in diagnosis rather than providing therapy.
Yes
The device obtains "diagnostic images" that, when interpreted by a trained physician, "may assist in diagnosis."
No
The device description explicitly states it is a "receive-only coil," which is a hardware component used in MRI systems. The performance studies also mention hardware-related tests like bio-compatibility and JEC60601-1 compliance.
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.
- Device Function: The Carotid Coil is a receive-only coil used in Magnetic Resonance Imaging (MRI). MRI is an in vivo imaging technique, meaning it takes images of the body directly without requiring a sample to be removed.
- Intended Use: The intended use is to obtain diagnostic images of the carotid arteries within the patient's body.
The device is a component of an MRI system, which is an imaging modality used for diagnosis, but it does not perform tests on samples taken from the body.
N/A
Intended Use / Indications for Use
The Carotid Coil is a receive-only coil, used for obtaining diagnostic images of carotid in magnetic resonance imaging systems. These images when interpreted by a trained physician, yielding information that may assist in diagnosis.
Diagnostic Uses: 2D, 3D imaging, proton density, T1 and T2 weighted imaging, 2D, 3D time of flight, phase contrast imaging.
Anatomic regions: carotid.
Product codes
MOS
Device Description
The Carotid Coil is an 8-channel phased array, receive-only coil, used for obtaining diagnostic images of carotid in magnetic resonance imaging systems. These images, when interpreted by a trained physician, yields information that may assist in diagnosis.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance Imaging
Anatomical Site
carotid
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 submitted Carotid Coil have been proved to be safe and effective by safety tests, performance tests, bio-compatibility tests, practical application tests and JEC60601-1 compliance tests. All the tests results are available in section 10 of this submission.
The Carotid Coil, comply with the appropriate medical device standards and are as safely and effectively substantially equivalent to the earlier identified predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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
OCT - 9 2009
1, -- - - - - - -
- This document can be copied and submitted to interested parties as required by 21 CFR 807.92.
510(k) Summary of Safety and Effectiveness
Submitter: Shanghai Chenguang Medical Technologies Co., Ltd
Telephone: -- 86-21-52961075-837 Fax: -- 86-21-52961075-826 E-mail: huangjie@shanghaicg.net Company Contact: Jie Huang Date Summary Prepared: Apr 10, 2009
Device Name: Carotid Coil Applicability: Compatible with PHILIPS 3.0T System Reason for 510(K): New Device Classification Name: Magnetic Resonance Diagnostic Device Classification Panel: Radiology Classification Number: 892.1000 Product Code: MOS Common Name: Magnetic Resonance Imaging Coil Proprietary Name: Model 5000004901 Carotid Coil Establishment Registration Number: 3006239787 Regulatory Class: II
Predicate Devices (Legally Marketed Devices)
The predicate device for the Carotid Coil is the Machnet Carotids Coil Array Assembly from Machnet B.V., with the 510k number of K012491.
Device Description
The Carotid Coil is an 8-channel phased array, receive-only coil, used for obtaining diagnostic images of carotid in magnetic resonance imaging systems. These images, when interpreted by a trained physician, yields information that may assist in diagnosis.
Intended Use
Diagnostic Uses: 2D, 3D imaging, proton density, T1 and T2 weighted imaging, 2D, 3D time of flight, phase contrast imaging.
Anatomic regions: carotid.
Comparison with Predicate Device:
The Carotid Coil and the predicate device has the similar intended use, work in the similar principle, is compliant with the similar standards and is of the similar safety and effectiveness.
1
مسلم
Conclusions
.
The submitted Carotid Coil have been proved to be safe and effective by safety tests, performance tests, bio-compatibility tests, practical application tests and JEC60601-1 compliance tests. All the tests results are available in section 10 of this submission.
i
As stated above, the Carotid Coil, comply with the appropriate medical device standards and are as safely and effectively substantially equivalent to the earlier identified predicate devices.
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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized depiction of an eagle with three lines forming its body and wings. The eagle faces right. 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
Shanghai Chenguang Medical Technologies Co., Ltd. % Mr. Casey Conry Senior Project Engineer Underwriters Laboratories, Inc. 1285 Walt Whitman Road MELVILLE NY 11747
OCT - 9 2009
Re: K092962
Trade/Device Name: Magnetic Resonance Diagnostic Device, 5000004901, Carotid Coil Regulation Number: 21 CFR §892.1000 Regulation Name: Magnetic Resonance Diagnostic Device Regulatory Class: II Product Code: MOS Dated: September 18, 2009 Received: September 25, 2009
Dear Mr. Conry:
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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); medical device reporting (reporting of medical
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device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Janine M. Morris
Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Section 3
510(k) Number (if known):
্রামের মাধ্যমে বাংলাদেশ করে আন্তর্জাতিক প্রকল্প করে আন্তর্জাতিক প্রকল্প করে আর করে আন্তর্জাতিক প্রকল্প করে আর করে আর করে আর করে আর করে আর করে আর করে আর করে আনা করে আর করে আর
Device Name: Magnetic Resonance Diagnostic Device, 5000004901, Carotid Coil
Indications for Use: The Carotid Coil is a receive-only coil, used for obtaining diagnostic images of carotid in magnetic resonance imaging systems. These images when interpreted by a trained physician, yielding information that may assist in diagnosis.
Prescription Use V (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)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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(Division Sign-Off) (Division Sign-On)
Division of Reproductive, Abdominal, and Radiological Device 510(k) Number