(46 days)
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Not Found
No
The summary describes a head coil for an MRI system and does not mention any AI or ML capabilities.
No
The device is used for imaging and spectroscopy, which are diagnostic procedures, not therapeutic ones.
No
The device description indicates it is a "Special Procedures II Head Coil" which is a component used for imaging, rather than a device that analyzes or interprets data to diagnose a condition. Its function is to acquire images and spectroscopic data, not to perform diagnosis.
No
The device description explicitly states "Special Procedures II Head Coil, Model #1400GE-64," which is a hardware component (a head coil for an MRI system).
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "2D and 3D Magnetic Resonance Imaging and Proton Spectroscopy of the anatomy of head and brain." This describes an imaging device used to visualize internal structures, not a device used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to diagnose diseases or conditions.
- Device Description: The device is a "Special Procedures II Head Coil" for an MRI system. This is a component of an imaging system, not a device that performs tests on biological samples.
- Input Imaging Modality: The input is "Magnetic Resonance Imaging and Proton Spectroscopy," which are imaging techniques, not methods for analyzing biological specimens.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device is clearly an imaging accessory used in vivo (within the body) as part of an MRI system.
N/A
Intended Use / Indications for Use
The 2D and 3D Magnetic Resonance Imaging and Proton Spectroscopy of the anatomy of head and brain. This device is used in conjunction with the PROBE (Proton Brain Exam) option.
Product codes
MOS
Device Description
Special Procedures II Head Coil, Model #1400GE-64
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
Magnetic Resonance Imaging
Anatomical Site
head and brain
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)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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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)
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§ 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 in shape and contains an image of three stylized birds in flight. The text "MINISTRY OF HEALTH & HUMAN SERVICES - USA" is arranged around the top and left side of the circle. The logo is simple and clean, and the text is easy to read.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 2 - 2005
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Mr. David M. Peterson Official Correspondent Midwest R.F., L.L.C. 535 Norton Drive, P.O. Box 348 HARTLAND WI 53029
Re: K051618
Trade/Device Name: Special Procedures II Head Coil, Model #1400GE-64 Regulation Number: 21 CFR 892. 1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II
Product Code: MOS Dated: May 23, 2005 Received: June 29, 2005
Dear Mr. Peterson:
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 (Premarket Approval), it may be subject to such 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)
The start of the same of the same of the same interess of your device to Jegal This letter will allow you to begin marketing your antial equivalence of your device to a legally
premarket notification. The FDA finding of substantial equivalers and thus, premarket notification. The PDA miding of Sabstantial or 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), pleased If you desire specific advice for your device on our laboring numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to prematic notification" (21 CFR Also, please note the regulation entitled, "firstmaning of your responsibilities under the Act from the 807.97). You may obtain other geleral information on Jour Copyright DIVIsion of Billand of Billion of its Internet address http://www.fda.gov/cdrh/industry/support/index.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): _K 0 516 18 18 1
Device Name: Special Procedures II Head Coil, Model # 17400GE-64
Indications For Use:
The 2D and 3D Magnetic Resonance Imaging and Proton Spectroscopy of The ZD and SD Magnetic Resolution in association with a General
the anatomy of head and brain. This device is used in conjunction with the anatomy of head and brain. This doview lo accurrently the PROBE (Proton Brain Exam) 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)
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K051618