(160 days)
Prestige 2.0T MRI System
Not Found
No
The document describes a standard MRI system and mentions a general image filter, but there is no mention of AI, ML, or related concepts in the intended use, device description, or other sections.
No
The device is an MRI system used for imaging and diagnosis, not for providing therapy.
Yes
The device is described as being useful "in determination of a diagnosis, surgery planning, or therapy planning" when images are interpreted by a trained physician, which directly indicates its role in aiding medical diagnosis.
No
The device description clearly states it is a "general purpose whole-body MRI system," which is a hardware device. While it mentions image processing software, the core device is a physical MRI machine.
No, 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. This testing is done outside of the body (in vitro).
- Device Function: The Gyrex Prima 1TG 1.0T MRI system is an imaging device that produces images of the internal structures of the body directly on the patient. It does not analyze specimens taken from the body.
- Intended Use: The intended use is to produce images for diagnosis, surgery planning, or therapy planning based on the interpretation of these images by a trained physician. This is a function of medical imaging, not in vitro testing.
Therefore, based on the provided information, the Gyrex Prima 1TG 1.0T MRI system is a medical imaging device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Elscint Prima 1TG 1.0T MRI system is designed as a general purpose whole-body MRI system for producing cross-sectional images of the internal structures of the head, body or extremities in transverse, sagittal, coronal or oblique planes. The images produced by the MR system reflect the spatial distribution of protons (hydrogen nuclei) and image appearance is determined by proton density, NMR relaxation time (T1 and T2) and flow. When interpreted by a trained physician, these images yield information that can be useful in determination of a diagnosis, surgery planning or therapy planning.
The Gyrex Prima 1TG 1.0T MRI system is a general purpose whole-body MRI system that produces images of the internal structures of the head, body, or extremities. The indications for use are not dissimilar to established indications for use for other general purpose whole-body MRI systems. The established indications for use are that when interpreted by a trained physician, MRI can be useful in determination of a diagnosis, surgery planning, or therapy planning and is used in a clinic or hospital setting.
Product codes (comma separated list FDA assigned to the subject device)
90 LNH
Device Description
The Elscint Prima 1TG 1.0T MRI system is designed as a general purpose whole-body MRI system for producing cross-sectional images of the internal structures of the head, body or extremities in transverse, sagittal, coronal or oblique planes. The images produced by the MR system reflect the spatial distribution of protons (hydrogen nuclei) and image appearance is determined by proton density, NMR relaxation time (T1 and T2) and flow. When interpreted by a trained physician, these images yield information that can be useful in determination of a diagnosis, surgery planning or therapy planning.
The major components changed or updated over that described in the predicate device submission are:
- A superconducting actively shielded 900mm bore 1.0T A maqnet
- A switching gradient amplifier and dual gradient coil A 7 combining to produce slew rates of 42 mT/m/msec and 72 m Thisec dependent on operational mode. This design is known as the Twin Gradient subsystem.
- Local phased array coils for imaging the shoulder and wrist A
- Operator selectable application of the Context Vision™ A imaqe filter
In addition, changes to RF Coils, sequences and system electronics have been performed to allow operation at 1.0T.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
MRI
Anatomical Site
head, body or extremities
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained physician, clinic or hospital setting
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): 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.
Prestige 2.0T MRI System
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.
0
KG70990
Summary of Safety and Effectiveness
The following information is made available pursuant to the requirements of the Safe Medical devices Act of 1990.
| 1. | Submitter: | Elscint MR, Inc.
2555 Midpoint Drive
Fort Collins, CO 80521
Tel: (970) 498-8088
Fax: (970) 498-8098 | AUG 25 1997 |
|----|------------|-----------------------------------------------------------------------------------------------------------------|-------------|
| | Contact: | Elizabeth F. Lowder, Director of Quality and Programs | |
| | Date: | March 13, 1997 | |
- Elscint Gyrex Prima 1TG 1.0T MRI System Product Identification: 2.
- Predicate device: Prestige 2.0T MRI System 3.
- Device Description and Indications for Use: 4.
The Elscint Prima 1TG 1.0T MRI system is designed as a general purpose whole-body MRI system for producing cross-sectional images of the internal structures of the head, body or extremities in transverse, sagittal, coronal or oblique planes. The images produced by the MR system reflect the spatial distribution of protons (hydrogen nuclei) and image appearance is determined by proton density, NMR relaxation time (T1 and T2) and flow. When interpreted by a trained physician, these images yield information that can be useful in determination of a diagnosis, surgery planning or therapy planning.
-
Comparison to Predicate Device ഗ്
The major components changed or updated over that described in the predicate device submission are: -
A superconducting actively shielded 900mm bore 1.0T A maqnet
-
A switching gradient amplifier and dual gradient coil A
- 7 combining to produce slew rates of 42 mT/m/msec and 72 m Thisec dependent on operational mode. This design is known as the Twin Gradient subsystem.
-
Local phased array coils for imaging the shoulder and wrist A
-
Operator selectable application of the Context Vision™ A imaqe filter
In addition, changes to RF Coils, sequences and system electronics have been performed to allow operation at 1.0T.
1
Conclusion: ୍.
lt is the opinion of Elscint MR, Inc. that the Prima 1TG MR system is substantially equivalent to the Prestige MR system. The Prima 1TG does not include any new indications for use, nor does use of this device result in any new potential hazards.
2
Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. In the center of the seal is a stylized image of a bird-like figure, possibly representing an eagle, with its wings spread. The overall design is simple and professional, reflecting the official nature of the organization.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 25 1997
Re:
Elizabeth Lowder Director, Quality and Programs Elscint MR, Inc. 2555 Midnoint Drive Fort Collins, CO 80525
K970990 Gyrex Prima ITG 1. 0T MRI System Dated: June 25, 1997 Received: June 30, 1997 Regulatory class: II 21 CFR 892.1000/Procode: 90 LNH
Dear Ms. Lowder:
We have reviewed your Section 510(k) notification of intent to market the device referenced above 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 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). 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS 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 submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under 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 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 diagnostic devices), please contact the Office of Compliance at (301) 594-4613. 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" (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.
h.7.Liau Yi
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
3
Elscint
Page 1 of 1
510(k) number ================================================================================================================================================================
Device Name: Gyrex Prima 1TG 1.0T MRI System
Indications for Use:
The Gyrex Prima 1TG 1.0T MRI system is a general purpose whole-body MRI system that produces images of the internal structures of the head, body, or extremities. The indications for use are not dissimilar to established indications for use for other general purpose whole-body MRI systems. The established indications for use are that when interpreted by a trained physician, MRI can be useful in determination of a diagnosis, surgery planning, or therapy planning and is used in a clinic or hospital setting.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of GDRH, Office of Device Evaluation (ODE) | ||
|---|---|---|
| (Division Sign-Off) | ||
| Division of Reproductive, Abdominal, ENT, | ||
| and Radiological Devices | ||
| 510(k) Number | K970990 | |
| Prescription Use | OR | Over-the Counter Use |
| (Per CRF 801.109) | ||
| X | (Optional Format 1-2-96) |