(65 days)
Not Found
No
The document lists several image processing techniques but does not mention AI, ML, or related terms like deep learning or neural networks.
No
Explanation: The device is described as an imaging system (Magnetic Resonance Imaging) used to image the body, not to treat any condition. The stated intended use is "MAGNETIC RESONANCE IMAGINE BODY WHOLE," which is diagnostic, not therapeutic.
Yes.
The device's intended use is "MAGNETIC RESONANCE IMAGINE BODY WHOLE," which involves creating images of the body. Magnetic Resonance Imaging (MRI) is a widely recognized diagnostic imaging modality used to detect and characterize diseases and abnormalities. The device description also mentions "diffusion weighted imaging" and "PCA color coded velocity maps," which are advanced imaging techniques often used for diagnostic purposes.
No
The device description details modifications to imaging sequences and post-processing techniques, which are software functions. However, the intended use and predicate devices clearly indicate this is a Magnetic Resonance Imaging (MRI) system, which is a hardware-based medical device. The software modifications are part of the larger hardware system.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples such as blood, urine, or tissue that have been taken from the human body to detect diseases or other conditions.
- Device Description: The description clearly states that this is a Magnetic Resonance Imaging (MRI) device. MRI is an imaging technique that uses magnetic fields and radio waves to create detailed images of organs and tissues within the body. It does not involve testing samples taken from the body.
- Intended Use: The intended use is "MAGNETIC RESONANCE IMAGINE BODY WHOLE," which is consistent with an imaging device, not an IVD.
- Input Imaging Modality: The input is "Magnetic Resonance," further confirming it's an imaging device.
Therefore, based on the provided information, this device is an imaging system, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
MAGNETIC RESONANCE IMAGING WHOLE BODY
Product codes (comma separated list FDA assigned to the subject device)
90 LNH
Device Description
The modifications include: new imaging sequences: FSAGE, Multishot EPI, Long ETL FSE, SSE, SSV, and diffusion weighted imaging, automated image filtering, MPR, PCA color coded velocity maps, Time Lapse post processing, Real-Time Localizer, double oblique localization, and multiple presaturation.
Mentions image processing
Time Lapse post processing
Mentions AI, DNN, or ML
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Input Imaging Modality
Magnetic Resonance Images
Anatomical Site
Whole Body and Organ Specific imaging
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
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.)
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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.
K945791, K954039, K962618, K970990
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.
0
- Submitter's Name and Address: Elscint, Inc., 505 Main Street, Hackensack, NJ 07601
Contact Person and Telephone No.: Steven M. Kay, (201) 342-2020
Date of Summary: 11 January, 1998
APR - 2 1998
| Device Name: | Elscint MRI Software Version 3.0 |
|---|---|
| Trade/Proprietary Name: | Elscint MRI Software Version 3.0 |
| Common Name: | MRI System |
| Classification Name: | Magnetic Resonance Diagnostic Device |
Gyrex 2T Prestige (K945791), 3. Predicate Device(s): Gyrex Privilege (K954039), Gyrex V-EP (K962618), Gyrex Prima 1TG (K970990)
4. Device Description:
The modifications include: new imaging sequences: FSAGE, Multishot EPI, Long ETL FSE, SSE, SSV, and diffusion weighted imaging, automated image filtering, MPR, PCA color coded velocity maps, Time Lapse post processing, Real-Time Localizer, double oblique localization, and multiple presaturation.
5. Intended Use:
| Anatomical Region: | Whole Body and Organ Specific imaging |
|---|---|
| Nuclei Excited: | Hydrogen |
| Diagnostic Use: | The production of Magnetic Resonance Images |
6. Safety:
The SAR, dB/dt, acoustic noise, and Bo are the same as the predicate devices.
All potential software safety hazards were minimized by design reviews, code reviews, and testing.
1
7. Effectiveness:
Acquisition Parameter Comparison
| Version 3.0 | Predicate Devices | |
|---|---|---|
| Minimum TE | 2ms | 4.3ms |
| Minimum TR | 7ms | 11ms |
| Minimum FOV | 4cm | 6.4cm |
| Maximum 2D Acquisition Matrix | $1024^2$ | $512^2$ |
| Maximum 3D Acquisition Matrix | $256^3$ or 128x512x512 | $256^3$ or 128x512x512 |
| Maximum Number of Echoes | 8 | 8 |
| Maximum Number of Slices | 80 | 80 |
| Minimum Slice Width | 0.5mm | 0.7mm |
The system performance parameters are not protocol dependent, and no acquisition software or hardware modifications which affect the system performance parameters are included in Version 3.0. The system performance parameters are therefore not affected by the current modification.
8. Equivalency Information Summary:
The FDA recommended MRI safety limits are not exceeded, and the effectiveness of the devices is improved in non-substantial ways from that of the predicate devices. It is Elscint's opinion that the Elscint MRI Systems with Software Version 3.0 are substantially equivalent in safety and effectiveness to their predicate devices.
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a bird-like figure.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Steven M. Kay Director, Regulatory Affairs and Quality Assurance Elscint. Inc. 505 Main Street Hackensack, NJ 07601
Re:
APR - 2 1998
· Software Version 3.0 for the Gyrex Magnetic Resonance Imaging Systems Dated: January 23, 1998 Received: January 27, 1998 Regulatory class: II 21 CFR 892.1000/Procode: 90 LNH
Dear Mr. Kay:
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 ensement date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Councilic 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 and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either 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 requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (2) 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 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 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 80) and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for question 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/cdr/dsmala.html".
Sincerely yours,
Lillian Yin, Ph.D.
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
3
K48 030 6 510(k) Number (if known):
VERSION 3.0 Device Name: _
Indications For Use:
MAGNETIC RESONANCE IMAGINE BODY WHOLE
(Please do not write below this line-continue on another page if needed)
(Concurrence of CDRH, Office of Device Evaluation(ODE)
Prescription Use (Per 21 CFR 801.109)
Over-The-Counter Use_
Kermit C. Biegner
OR
(Division Sign-Off) … Division of Reproductive, Abdominal, ENT and Radiological Devic
510(k) Number K960306