(237 days)
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Not Found
No
The document describes a standard MRI system and explicitly states the software and hardware are equivalent or identical to the predicate device, which is a mature technology. There is no mention of AI, ML, or related concepts.
No
The "Intended Use / Indications for Use" section explicitly states that the device is "indicated for use as diagnostic devices."
Yes
The "Intended Use / Indications for Use" and "Device Description" sections explicitly state multiple times that the Philips Gyroscan NT systems are "indicated for use as diagnostic devices."
No
The device description explicitly states that the device includes hardware components ("The hardware used in Release 5 is identical to the predicate device.") and describes a physical system (MR Imaging system).
Based on the provided information, the Philips Gyroscan NT systems are not IVD (In Vitro Diagnostic) devices.
Here's why:
- IVD devices are used to examine specimens taken from the human body. The description of the Gyroscan NT systems clearly states they produce images and/or spectra of the internal structure and/or function of the head, body, or extremities. This is done in vivo (within the living body), not in vitro (in a test tube or other artificial environment).
- The intended use is for diagnostic imaging. The system is used to visualize internal structures and functions to assist in diagnosis, which is a core function of medical imaging devices, not IVD devices.
Therefore, the Philips Gyroscan NT systems are medical imaging devices, specifically MRI systems, and not IVD devices.
N/A
Intended Use / Indications for Use
The Philips Gyroscan NT systems are indicated for use as diagnostic devices that produce transverse, sagittal, coronal, and oblique cross-sectional images, spectroscopic images and/or spectra, based upon 1H and 31P metabolites, and that display the internal structure and/or function of the head, body, or extremities. These images and/or spectra when interpreted by a trained physician, yield information that may assist in diagnosis.
Product codes
90 LNH
Device Description
The GYROSCAN T5-NT (0.5T), GYROSCAN T10-NT (1.0T), GYROSCAN ACS-NT (1.5T) Release 5 series are designed and manufactured to comply with the relevant safety standards. Adequate safety precautions include RF-limit protection, rate of gradient change, and selection/decoupling circuitry for the applicable coils. The systems, as their predecessors, are indicated for use as diagnostic devices producing transverse, sagittal, coronal, and oblique cross-sectional images and displaying the internal structure of the head, body, or extremities. The software used in Release 5 is equivalent to the software used in the predicate device. The hardware used in Release 5 is identical to the predicate device.
Mentions image processing
Yes
Mentions AI, DNN, or ML
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Input Imaging Modality
MR Imaging
Anatomical Site
head, body, or extremities
Indicated Patient Age Range
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Intended User / Care Setting
trained physician
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)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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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.
0
Summary of Safety and Effectiveness
MAY 2 9 1997
Philips GYROSCAN NT Systems
8963990
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- The GYROSCAN T5-NT (0.5T), GYROSCAN T10-NT (1.0T), GYROSCAN ACS-NT (1.5T) Release 5 series are designed and manufactured to comply with the relevant safety standards. Adequate safety precautions include RF-limit protection, rate of gradient change, and selection/decoupling circuitry for the applicable coils.
- The systems, as their predecessors, are indicated for use as diagnostic devices 2. producing transverse, sagittal, coronal, and oblique cross-sectional images and displaying the internal structure of the head, body, or extremities. These images, when interpreted by a trained physician, vield information useful in the determination of diagnosis.
- MR Imaging utilizes mature technology to visualize images with which the industry 3. and users have many years of experience. A Comprehensive Operator's Manual contains adequate instructions and provides sufficient cautions and warnings to ensure safe operation.
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- The software used in Release 5 is equivalent to the software used in the predicate device. The hardware used in Release 5 is identical to the predicte device.
Philips Medical Systems North America Company feels that sufficient information and data are contained in this submission to enable CDRH to reach a determination of substantial equivalence.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three lines extending from its back, representing the department's commitment to health and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 9 1997
Peter Altman Director of Regulatory Affairs Philips Medical Systems North America Company 710 Bridgeport Avonue .... P.O. Box 860 Shelton, Connecticut 06484-0917 Re: K963990 GYROSCAN T5-NT, T10-NT and ACS-NT Release 5 Series Dated: March 6, 1997 Received: March 7, 1997 Regulatory class: II ... 21 CFR 892.1000/Procode: 90 LNH
Dear Mr. Altman:
We have reviewed your Section 510(k) notification of intent to market the device and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactnent date of the Medical Device Amendances or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, ind Cosmetic Act (Act). 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 III (Prematce 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 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Pracice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification does not affect any obligation you might have under sections 51 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 of substantial equivalence of your device to a legally marketed predication 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 (2) CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4591 for Radiology devices, or 594-4613 for Ear, Nose and Throat devices. Additionally, for questions on the promotion and advertising of your device, please postaal the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premacted notification" (21 CFR 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) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
William
Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Frien Petr 1 in
510(k) Number (if known): __ Unknown
Philips Gyroscan T5-NT, T10-NT, and ACS NT Device Name :
Indications For Use :
The Philips Gyroscan NT systems are indicated for use as diagnostic devices that produce transverse, sagittal, coronal, and oblique cross-sectional images, spectroscopic images and/or spectra, based upon 1H and 31P metabolites, and that display the internal structure and/or function of the head, body, or extremities. These images and/or spectra when interpreted by a trained physician, yield information that may assist in diagnosis.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David A. Seymore
(Division Sign-Off)
Division of Reproductive, Abdominal, EN and Radiological Devices 510(k) Number
Prescription Use ( Per 21 CFR 801.109 OR
Over-The-Counter Use
(Optional Format 1-2-96)