(76 days)
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Not Found
No
The document describes a standard MRI system and its modifications, focusing on hardware capabilities and traditional imaging techniques. There is no mention of AI, ML, or related concepts in the intended use, device description, or performance studies.
No
The device is described as a "diagnostic imaging device" used to produce images for "determining a diagnosis," not for therapy.
Yes
The text explicitly states: "The Profile/i system is indicated for use as a diagnostic imaging device". It also mentions that the images provide "information that can be useful in determining a diagnosis".
No
The device description clearly describes a whole body scanner utilizing a permanent magnet and expanded gradient capabilities, indicating it is a hardware system, not software only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens (like blood, urine, or tissue) taken from the body. They perform tests in vitro (in glass, or outside the body).
- The Signa Profile/i system is an imaging device. It produces images of the internal structures of the body in vivo (within the living body) using magnetic resonance.
The description clearly states its purpose is to produce images of internal structures and organs of the entire body for diagnostic imaging, which is the function of an imaging device, not an IVD.
N/A
Intended Use / Indications for Use
The Signa Profile/i system is an open, whole body scanner designed to support improved higher resolution imaging and shorter scan times. The Profile/i system is indicated for use as a diagnostic imaging device to produce transverse, sagittal, coronal and oblique images of the internal structures and organs of the entire body, including, but not limited to, the musculocskelatal, vascular, cardiac, and neuro systems. The images produced by the Signa Profile/i system reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. The NMR properties that determine the image appearance are proton density, spin-lattice relaxation time (T1), spin-spin relaxation time (T2) and flow. When interpreted by a trained physician, these images provide information that can be useful in determining a diagnosis.
Due to the 'open' design of the system, the Profile/i may also be utilized for imaging during interventional procedures when performed with MR compatible devices such as, in-room display and MR safe biopsy needles.
Product codes (comma separated list FDA assigned to the subject device)
90 LNH
Device Description
The Signa Profile// System is a modification to the Signa ProfielMR Systems which utilizes a permanent magnet to acquire 2D single-slice and multi-slice, and 3D volume images. In addition to the wide variety of pulse sequences provided to the Signa Profile operator, such as inversion recovery, spin echo, gradient echo, gradient recalled, and steady state, and free precession acquisitions, the Signa Profile// operator has the ability for shorter scan due to expanded gradient capabilities. Imaging options such as cardiac gating, times peripheral gating, flow compensation and fat/water suppression are provided to suppress artifacts due to physiological motion and improve image quality.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
Magnetic Resonance
Anatomical Site
internal structures and organs of the entire body, including, but not limited to, the musculocskelatal, vascular, cardiac, and neuro systems.
Indicated Patient Age Range
Not Found
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)
The Signa Profile// System was evaluated to the appropriate NEMA performance standards as well as the IEC 601-1 International medical equipment safety standard and IEC 601-2-33 Particular requirements for the safety of magnetic resonance equipment for medical diagnosis. The Signa Profile/i System is comparable to the Signa Profile MR Systems.
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.
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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).
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
K 99 2135
8 1999
page 1 of 2
GE Medical Systems
P.O. Box 414. W-709 Milwaukee, WI 53201 USA
SUMMARY OF SAFETY AND EFFECTIVENESS
- This 510(k) summary of safety and effectiveness information is submitted in accordance o with the requirements of 21 CFR Part 807.87(h).
- o Identification of Submitter Larry A. Kroger, Ph.D., 414-544-3894, June 18, 1999
- o Identification of the Product Signa Profile// Magnetic Resonance System
Manufacturer Address:
GE Yokogawa Medical Systems, Ltd. 4-7-127, Asahigaoka, Hino-Shi Tokyo, 191 Japan
0 Marketed Devices
The Signa Profile/ System is substantially equivalent to the currently marketed Signa Profile System. The Signa Profile// Magnetic Resonance System adds interventional applications capability and a new Gradient Coil with a slew rate of 25 mT/m/sec.
o Device Description
The Signa Profile// System is a modification to the Signa ProfielMR Systems which utilizes a permanent magnet to acquire 2D single-slice and multi-slice, and 3D volume images. In addition to the wide variety of pulse sequences provided to the Signa Profile operator, such as inversion recovery, spin echo, gradient echo, gradient recalled, and steady state, and free precession acquisitions, the Signa Profile// operator has the ability for shorter scan due to expanded gradient capabilities. Imaging options such as cardiac gating, times peripheral gating, flow compensation and fat/water suppression are provided to suppress artifacts due to physiological motion and improve image quality.
Indications for Use
0
The Signa Profile// system is an open, whole body scanner designed to support improved higher resolution imaging and shorter scan times. The Profile// system is indicated for use as a diagnostic imaging device to produce transverse, sagittal, coronal and oblique images of the internal structures and organs of the entire body, including, but not limited to, the musculocskelatal, vascular, cardiac, and neuro systems. The images produced by the Signa Profile/i system reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. The NMR properties that determine the image appearance are proton density, spin-lattice relaxation time (T1), spin-spin relaxation time (T2) and flow. When interpreted by a trained physician, these images provide information that can be useful in determining a diagnosis.
Image /page/0/Picture/17 description: The image shows the General Electric (GE) logo, which consists of the letters 'GE' intertwined within a circular border. The letters are stylized and connected, with the 'G' and 'E' flowing together in a cursive-like manner. The circular border has decorative swirls or flourishes around the letters, adding to the logo's distinctive design.
1
Image /page/1/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined within a circle. The letters are stylized and appear to be handwritten, with decorative flourishes. The logo is black and white.
page 2 of 2
GE Medical Systems
P.O. Box 414, W-709 Milwaukee, WI 53201 USA
SUMMARY OF SAFETY AND EFFECTIVENESS
Due to the 'open' design of the Profile/i can also be utilized for imaging during interventional procedures when performed with MR compatible devices such as, in-room display, nad MR safe biopsy needles.
0 Comparison with Predicate
The Signa Profile// System is comparable to the Signa Profile Systems with the main difference being with the Gradient coil which allows for expanded gradient capabilities, enabling shorter scan times.
o Summary of Studies
The Signa Profile// System was evaluated to the appropriate NEMA performance standards as well as the IEC 601-1 International medical equipment safety standard and IEC 601-2-33 Particular requirements for the safety of magnetic resonance equipment for medical diagnosis. The Signa Profile/i System is comparable to the Signa Profile MR Systems.
o Conclusions
It is the opinion of GE that the Signa Profile// System is substantially equivalent to the Signa Profile MR Systems. The Signa Profile/i Magnetic Resonance System does not include any new indications for use, nor does use of this device result in any new potential hazards.
2
Public Health Service
8 1999
Larry A. Kroger, Ph.D. Senior Regulatory Programs Manager General Electric Medical Systems P.O. Box 414. W-709 Milwaukee, Wisconsin 53201
Re:
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
K992135 Signa Profile/I Magnetic Resonance System Dated: June 18, 1999 Received: June 24, 1999 Regulatory Class: II 21 CFR 892.1000/Procode: 90 LNH
Dear Dr. Kroger:
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 legally marketed predicate 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). 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 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 (QS) 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 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 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/dsma/dsmamain.html".
Sincerely yours,
CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radioloqical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
Image /page/2/Picture/15 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird with three stylized human profiles incorporated into its design.
3
510(k) Number (if known): K 992135
Device Name: Signa Profile/i Magnetic Resonance System
Indications For Use:
The Signa Profile/i system is an open, whole body scanner designed to support improved higher resolution imaging and shorter scan times. The Profile/i system is indicated for use as a diagnostic imaging device to produce transverse, sagittal, coronal and oblique images of the internal structures and organs of the entire body, including, but not limited to, the musculocskelatal, vascular, cardiac, and neuro systems. The images produced by the Signa Profile/i system reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. The NMR properties that determine the image appearance are proton density, spin-lattice relaxation time (T1), spin-spin relaxation time (T2) and flow. When interpreted by a trained physician, these images provide information that can be useful in determining a diagnosis.
Due to the 'open' design of the system, the Profile/i may also be utilized for imaging during interventional procedures when performed with MR compatible devices such as, in-room display and MR safe biopsy needles.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David A. Seyram
vision of Reproductive, Abdominal, EN and Radiological Devi
510(k) Number K992135
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use