(20 days)
No
The document describes a standard MRI system and an image reconstruction technique (ASSET) that relies on coil sensitivity, not AI/ML algorithms. There is no mention of AI, ML, or related concepts like training/test sets.
No
The device is described as a "diagnostic imaging device" used to produce images for "determining a diagnosis," rather than for treating a medical condition.
Yes
The "Intended Use / Indications for Use" section explicitly states, "The Signa Magnetic Resonance 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 explicitly states it is an "image reconstruction technique used in conjunction with phased array coils," which are hardware components of an MRI system. The intended use also describes a "whole body scanner," which is a hardware device. Therefore, this is not a software-only medical device.
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.
- Device Function: The Signa Magnetic Resonance System is an imaging device that produces images of the internal structures of the body using magnetic resonance. It does not analyze specimens taken from the body.
- Intended Use: The intended use clearly states it's a "diagnostic imaging device" that produces images for interpretation by a physician. This is consistent with an in-vivo imaging system, not an in-vitro diagnostic.
The information provided describes a medical imaging device used directly on the patient, not a device used to test samples outside of the body.
N/A
Intended Use / Indications for Use
The Signa Magnetic Resonance System is a whole body scanner. The Signa Magnetic Resonance System is indicated for use as a diagnostic imaging device to produce transverse, sagittal, coronal and oblique images of the internal structures of the head or body. The images produced by the Signa Magnetic Resonance 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.
Product codes
90-LNH
Device Description
ASSET (Array Spatial Sensitivity Encoding Technique) is an image reconstruction technique used in A conjunction with phased array coils in which the number of phase encode steps is reduced by increasing the distance between steps, or equivalently, by reducing the field of view. Aliasing or wrapping caused by the object extending outside the reduced field of view is eliminated using knowledge of the B1 fields of the coils.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance
Anatomical Site
whole body, head or body
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained physician
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 ASSET Imaging Option was developed in conformance with design control requirements as specified in 21 C.F.R. 820.30. Software hazard analysis and verification test procedures were completed. Evaluation testing was done to verify the performance of the option.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
K012200, K990550, K003575, K992746
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.
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Ko12970
SEP 2 4 2001
Page 1 of 2
GE Medical Systems
eral Flectric Company 0. Box 414, Milwaukee, WI 53201
510(k) Summary
This 510(k) summary of safety and effectiveness information is submitted in accordance with the requirements of 21 CFR Part 807.92(c).
| Submitter: | GE Medical Systems
PO Box 414
Milwaukee, WI 53201 |
|-----------------|---------------------------------------------------------|
| Contact Person: | Larry A. Kroger Ph.D.
Manager, Regulatory Program |
| Telephone: | 262- 544-3894 |
| Fax: | 262- 544-3863 |
| Date Prepared: | August 30, 2001 |
Device Name:
GE Signa ASSET Imaging Option Magnetic Resonance Diagnostic System, 21 CFR 892.1000, 90-LNH
Marketed Device:
The Signa ASSET Imaging Option is substantially equivalent to the Array Processor subsystem and reconstruction techniques of the currently marketed Signa 1.5T TwinSpeed Magnetic Resonance System rconstruction recemiques of the outsions of the Supers on K006313) and Signa HFO/i MR System (K992746).
Device Description:
ASSET (Array Spatial Sensitivity Encoding Technique) is an image reconstruction technique used in A conjunction with phased array coils in which the number of phase encode steps is reduced by increasing the distance between steps, or equivalently, by reducing the field of view. Aliasing or wrapping caused by the object extending outside the reduced field of view is eliminated using knowledge of the B1 fields of the coils.
Indications for Use:
The Signa Magnetic Resonance System is a whole body scanner. The Signa Magnetic Resonance System is indicated for use as a diagnostic imaging device to produce transverse, sagittal, coronal and oblique images of the internal structures of the head or body. The images produced by the Signa Magnetic Resonance 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.
1
Image /page/1/Picture/0 description: The image shows the text "GE Medical Systems". The text is in a bold, sans-serif font. The text is black and the background is white. The text is centered in the image.
Image /page/1/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'g' and 'e' intertwined within a circular border. The logo is black and white.
Page 1 of 2
General Electric Company P.O. Box 414, Milwaukee, WI 53201
Comparison with Predicate Device:
It is the opinion of GE Medical Systems that the ASSET Imaging Option is substantially equivalent to the Array Processor subsystem and Reconstruction Techniques used in the currently cleared Signa 1.5T TwinSpeed Magnetic Resonance System (K012200), Signa VH/i MR System (K990550; K003575; and I winspect hilghout Resorted (K992746). It has the same intended use, and operating modes as the predicate devices.
Summary of Studies:
The ASSET Imaging Option was developed in conformance with design control requirements as specified in 21 C.F.R. 820.30. Software hazard analysis and verification test procedures were completed. Evaluation testing was done to verify the performance of the option.
Conclusion:
It is the opinion of GE that the ASSET Imaging option does not result in any new potential hazards.
2
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized image of three human profiles facing right, stacked on top of each other. The profiles are connected by flowing lines that resemble a ribbon or wave. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 2 4 2001
Larry Kroger, Ph.D. Regulatory Programs Manager GE Medical Systems General Electric Company P.O. Box 414 MILWAUKEE WI 53201
Re: K012970 Trade/Device Name: GE Signa Asset Imaging Option for MRI Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic Resonance Diagnostic Device Regulatory Class: II Product Code: 90 LNH Dated: August 30, 2001 Received: September 4, 2001
Dear Dr. Kroger:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave rovewary our becamined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for associated in the Merceded)76, the enactment date of the Medical Device Amendments, or to conniner of the 11th 11th 2011-05-12, 11:22 accordance with the provisions of the Federal Food, Drug, de nees mar nat o boon resulted require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may , itereror mains 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 (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must or any I with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set (21 OFF Part 801), accems (QS) regulation (21 CFR Part 820); and if applicable, the electronic rordly and ation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.
3
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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
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 Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer 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,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
KO12970 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Signa ASSET Imaging Option
Indications For Use:
The Signa Magnetic Resonance System is a whole body scanner. The Signa Magnetic Resonance System is indicated for use as a diagnostic imaging device to produce transverse, sagittal, coronal and oblique images of the internal structures of the head or body. The images produced by the Signa Magnetic Resonance 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.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
om Concurrence of DRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________