(185 days)
Not Found
No
The description focuses on a new imaging sequence (EPI) which is a technical modification to the image acquisition process, not an AI/ML algorithm for image analysis or processing. There are no mentions of AI, ML, or related concepts, nor any descriptions of training or test sets typically associated with AI/ML development.
No
The device is described as an imaging technique (Echo Planar Imaging) for Magnetic Resonance Imaging, which is used for diagnostic purposes rather than therapeutic treatment.
Yes
The device is described as an "imaging technique" that produces images (Whole Body Magnet Resonance Imaging) which are used for diagnostic purposes. Imaging is a common diagnostic tool.
No
The device description explicitly states it is a new "imaging sequence," which is a software component that runs on an existing MRI hardware system. The submission describes a modification to an existing MRI system (K945791 and K954039) and focuses on the performance of the imaging sequence itself, not a standalone software application.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "Whole Body Magnet Resonance Imaging." This describes an imaging technique used to visualize the internal structures of the body.
- Device Description: The device is a modification to an existing MRI system, specifically a new imaging sequence (EPI). This is a component of an imaging system, not a test performed on biological samples.
- Lack of IVD Characteristics: There is no mention of:
- Analyzing biological samples (blood, urine, tissue, etc.).
- Providing diagnostic information based on the analysis of biological samples.
- Measuring specific analytes or biomarkers.
IVDs are devices used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device is clearly focused on generating images of the body itself, not analyzing biological samples.
N/A
Intended Use / Indications for Use
Whole Body Magnet Resonance Imaging
Product codes
90 LNH
Device Description
The modification is a new imaging sequence referred to as Echo Planar Imaging (EPI). EPI is an imaging technique which produces multiple gradient echoes after an initial RF excitation, thereby allowing faster imaging than standard gradient echo techniques.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance Imaging (MRI)
Anatomical Site
Whole Body
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
The EPI sequences produce images that are comparable with those produced using other imaging sequences. The EPI sequences are limited in resolution, but they are faster than other imaging sequences which makes them useful for particular applications.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
Elscint EPI for the Gyrex Prestige and Privilege Systems
K96504
JUN 1 6 1997
SUMMARY OF SAFETY AND EFFECTIVENESS
- Device Name: EPI for the Gyrex Prestige and Privilege systems.
1.2 Classification Name: Magnetic Resonance Diagnostic Device
1.3 Submitter: Elscint, Inc., 505 Main St., Hackensack, NJ 07601
1.4 510(k) Number:____________________________________________________________________________________________________________________________________________________________
- Device Modification Description
The modification is a new imaging sequence referred to as Echo Planar Imaging (EPI). EPI is an imaging technique which produces multiple gradient echoes after an initial RF excitation, thereby allowing faster imaging than standard gradient echo techniques.
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- The MRI safety parameters, SAR, dB/dt, Bo, and acoustic noise, are unchanged by the . current modification.
- Electrical, mechanical, and biocompatibility safety issues do not apply to the current . modification.
- No new software hazards have been introduced, so the software level of concern remains . minor.
- The current modifications do not affect the site planning, installation, or service . manuals, and do not require any new safety labeling.
5. Effectiveness
The EPI sequences produce images that are comparable with those produced using other imaging sequences. The EPI sequences are limited in resolution, but they are faster than other imaging sequences which makes them useful for particular applications.
- Substantial Equivalency Statement
The FDA recommended MRI safety limits are not exceeded, and the effectiveness of the modified devices is similar to that of the predicate devices. It is Elscint's opinion that the Prestige and Privilege systems with the new EPI sequences are substantially equivalent to their predicate devices in terms of safety and effectiveness.
1
Image /page/1/Picture/0 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the caduceus. The seal is black and white.
JUN 16 1997
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Beny Sherer Safety Officer Elscint, Inc. 86 Orchard Street Hackensack, NJ 07601
Re: K965044
EPI for Gyrex Prestige and Privilege MRI Systems Dated: March 24, 1997 Received: March 25, 1997 Regulatory Class: II 21 CFR 892.1000/Procode: 90 LNH
Dear Mr. Sherer:
16
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 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 III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice 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 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 yritro 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 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.
William M
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
Page _ / of _ /
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name:_EPI for the Gyrex Prestige and Privilege MRI Systems
Indications For Use:
学
Whole Body Magnet Resonance Imaging
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David G. Seymon
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
O(k) Number K965044
X Prescription Use_ (Per 21 CFR 801.109) Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)