(20 days)
Not Found
Not Found
No
The summary describes an RF coil, a hardware component for MRI, and does not mention any software or processing capabilities that would involve AI/ML.
No
The device is described as an "RF coil for Magnetic Resonance Imaging System" for producing diagnostic images, indicating it's an accessory to a diagnostic imaging system, not a therapeutic device.
No
Explanation: The device is an RF coil for an MRI system, which produces images. The diagnostic interpretation is performed by a trained physician, not by the device itself.
No
The device description explicitly states it is a "Neurovascular Array Coil (RF coil for Magnetic Resonance Imaging System)", which is a hardware component.
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 description clearly states the device is an "RF coil for Magnetic Resonance Imaging System" used to "produce diagnostic images of the head and neck." This is a component of an imaging system that interacts with the patient's body directly (via radiofrequency fields) to generate images, not to analyze samples taken from the body.
- Intended Use: The intended use is to produce images for interpretation by a physician, not to perform tests on biological samples.
Therefore, the HNC-127 Neurovascular Array Coil is a component of a medical imaging system, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
To be used in conjunction with a Magnetic Resonance Scanner to produce diagnostic images of the head and neck, that can be interpreted by a trained physician.
Product codes
90 MOS
Device Description
HNC-127 Neurovascular Array Coil (RF coil for Magnetic Resonance Imaging System)
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance Scanner
Anatomical Site
Head and neck
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle with its wings spread, depicted with three curved lines forming the wings and body.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 4 2001
Mr. Thomas Schubert President MRI Devices Corporation 1515 Paramount Drive WAUKESHA WI 53186
Re: K012353
HNC-127 Neurovascular Array Coil (RF coil for Magnetic Resonance Imaging System) Dated: July 20, 2001 Received: July 25, 2001-Regulatory Class: II 21 CFR 892.1000/Procode: 90 MOS
Dear Mr. Schubert:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the we have reviewed your decubli 510(t) nontoations of muse stated in the enclosure) to legally marketed predicate devices device is substantially Quivalin (10) the matement date of the Medical Device Amendments, or to devices marked in meestance commerce provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, that have been reclassiniou in accordance will the provisions of the Act. The general controls provisions of the Act therefore, market the device, subjoct on the gations of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class III (Premarket Approval), it may be subject If your device is classified (so above paint stims affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantialiy equivalent determination assumes compliance with the Current Good Manufacturing I I lie 21, Pauls 600 it 692. A subsantany equi nient research (QS) for Medical Devices: General regulation (21 CFR Part I rache requirements, as bet son inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure 620) and mat, unodic Qu mayochols, the regulatory action. In addition, FDA may publish further announcements to comply with the Unit regulation into result in regaratory this response to your premarket notification submission in comes may obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding I his rubstantial 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 and additionally 809.10 for in vitro If you desire specific devices of Compliance at (301) 594-4639. 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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 1638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely vours.
Nancy Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure (s)
1
Special 510(K) Application, Device Modification Special 910(11) Appurovascular Array Coil, July 20, 2001
Section C – Statement of Indications for Use:
Applicant: MRI Devices Corporation Applicano. Mer (if known):___________________________________________________________________________________________________________________________________________________ Model HNC-127 Neurovascular Array Coil Device Name:
Indications for use:
To be used in conjunction with a Magnetic Resonance Scanner to produce To be used in confullential withing
diagnostic images of the head and neck, that can be interpreted by a trained physician.
Nancy C. Hogdon
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K012353
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use or (Per 21 CFR 801.109)
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)