(63 days)
Not Found
Not Found
No
The summary describes a physical MRI coil and associated software options, with no mention of AI or ML capabilities in image processing, analysis, or any other function.
No
The device is described as a "Brain Coil" used for "Magnetic Resonance Imaging and Proton Spectroscopy of the Brain and anatomy of the head." This indicates it is an imaging device used for diagnostic purposes, not for treating a condition.
Yes
The device performs 2D and 3D Magnetic Resonance Imaging and Proton Spectroscopy of the Brain and anatomy of the head, which are diagnostic procedures used to visualize internal structures for medical purposes.
No
The device description explicitly states "Brain Coil, Model # 9900GE-64", which is a hardware component used in conjunction with an MRI scanner.
Based on the provided information, 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 description clearly states the device is a "Brain Coil" used in conjunction with an MRI scanner for "Magnetic Resonance Imaging and Proton Spectroscopy of the Brain and anatomy of the head." This is an in vivo (within the living body) imaging procedure, not an in vitro test on a sample.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples, detection of biomarkers, or any other activities typically associated with IVD devices.
Therefore, the Brain Coil, Model # 9900GE-64, is an accessory for an MRI scanner used for medical imaging, which is a different category of medical device than an IVD.
N/A
Intended Use / Indications for Use
The 2D and 3D Magnetic Resonance Imaging and Proton Spectroscopy of the Brain and anatomy of the head. This device is used in conjunction with a General Electric 1.5 Tesla MRI Scanner and for Spectroscopy will need the addition of the PROBE (Proton Brain Exam) software option.
Product codes (comma separated list FDA assigned to the subject device)
90 MOS
Device Description
Not Found
Mentions image processing
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Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance Imaging
Anatomical Site
Brain and anatomy of the head
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
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.
Not Found
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.
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Image /page/0/Picture/1 description: The image is a black and white logo. The logo is circular and contains an image of a bird in flight. The bird is stylized with three curved lines representing its body and wings. The text "U.S. Public Health Service" is written around the top half of the circle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1 8 2003
Mr. Ralph S. Hashoian Managing Member Clinical MR Solutions, LLC 3735 Shadybrook Place BROOKFIELD WI 53005
Re: K031536 Trade/Device Name: Brain Coil, Model
9900GE-64 Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: 90 MOS Dated: May 13, 2003 Received: May 16, 2003
Dear Mr. Hashoian:
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 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); 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.
1
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 Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of the letter:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Statement of Indication for Use 5.0 Attachment 3:
510(K) Number (if known): ____________________________________________________________________________________________________________________________________________________
Brain Coil, Model # 9900GE-64 Device Name:
Indications for Use:
The 2D and 3D Magnetic Resonance Imaging and Proton Spectroscopy of the Brain and anatomy of the head. This device is used in conjunction with a General Electric 1.5 Tesla MRI Scanner and for Spectroscopy will need the addition of the PROBE (Proton Brain Exam) software option.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-off) |
|---|
| Division of Reproductive, Abdominal, ENT, |
| and Radiological Devices |
510(K) Number
Prescription Use
(Per 21 CFR 801.109)
OR
Over the Counter Use (Optional Format 1-2-96)
CMRS Brain Coil #9900GE-64
Attachment 3
Indication for Use
(Division Sign-Off) Division of Reproductive, Abdominal. and Radiological Devic 510(k) Number
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