(30 days)
Not Found
No
The summary describes a standard MRI system and coil, focusing on imaging capabilities and anatomical sites. 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" intended for "imaging of the Neck, Spine, Abdomen/Thorax and the extremities," which indicates a diagnostic rather than therapeutic purpose.
Yes
The "Device Description" explicitly states that "The Signa® 3.0T magnetic resonance system is a diagnostic imaging device".
No
The device description clearly states it is a "diagnostic imaging device that produces transverse, coronal, sagittal and oblique images of the internal structures" and mentions a "Transmit/Receive Body Imaging Coil," indicating it is a hardware-based medical device (an MRI system and its coil).
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "imaging of the Neck, Spine, Abdomen/Thorax and the extremities." This describes an in-vivo (within a living organism) diagnostic imaging procedure, not an in-vitro (outside of a living organism) test performed on biological samples.
- Device Description: The description confirms it's a "diagnostic imaging device that produces transverse, coronal, sagittal and oblique images of the internal structures..." This further reinforces its role in capturing images of the body directly.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or laboratory procedures, which are hallmarks of IVD devices.
Therefore, the device described is a Magnetic Resonance (MR) imaging system component used for diagnostic imaging of the human body, not an in-vitro diagnostic device.
N/A
Intended Use / Indications for Use
The indications for use for the 3.0T Signa®VH/i (Signa® 3.0T MR System) Transmit/Receive Body Imaging Coil expands the imaging capability of the 3.0T Signa®VH/i MR Imaging System.
The Transmit/Receive Body Imaging Coil is intended for imaging of the Neck, Spine, Abdomen/Thorax and the extremities.
Product codes
90-LNH
Device Description
The Signa" 3.0T magnetic resonance system is a diagnostic imaging device that produces transverse, coronal, sagittal and oblique images of the internal structures of the head, neck, spine, abdomen/thorax and the extremities. The Signa® 3.0T system is designed to support high resolution imaging and multinuclear spectroscopy. Previously cleared software options, coils, and other accessories may be used with the Signa® 3.0T MR System.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance
Anatomical Site
Neck, Spine, Abdomen/Thorax, extremities, head
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
Testing was performed to demonstrate that the design modifications to the Signa® 3.0T MR System meet predetermined acceptance criteria.
Summary of Performance Studies
Study type: Not Found
Sample size: Not Found
AUC: Not Found
MRMC: Not Found
Standalone performance: Not Found
Key results: The results of the testing described above demonstrate that the Signa® 3.0T MR System is substantially equivalent to the currently cleared 3.0T Signa® VH/i transmit/Receive Body Imaging Coil and the 3.0 T Signa® VH/i system magnetic resonance system.
Key Metrics
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
GE Medical Svstems
General Electric Company P.O. 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 Programs |
| Telephone: | 262-544-3894 |
| Fax: | 262-544-3863 |
| Date Prepared: | July 16, 2002 |
Device Name:
Signa® 3.0T Magnetic Resonance System Magnetic Resonance Diagnostic System, 21 CFR 892.1000, 90-LNH
Marketed Device:
The Signa® 3.0T Magnetic Resonance System is substantially equivalent to the currently marketed 3.0T Signa® VH/i transmit/Receive Body Imaging Coil (K003613) and the 3.0 T Signa® VH/i system (K990550).
Device Description:
The Signa" 3.0T magnetic resonance system is a diagnostic imaging device that produces transverse, coronal, sagittal and oblique images of the internal structures of the head, neck, spine, abdomen/thorax and the extremities. The Signa® 3.0T system is designed to support high resolution imaging and multinuclear spectroscopy. Previously cleared software options, coils, and other accessories may be used with the Signa® 3.0T MR System.
Indications for Use:
The indications for use for the 3.0T Signa®VH/i (Signa® 3.0T MR System) Transmit/Receive Body Imaging Coil expands the imaging capability of the 3.0T Signa®VH/i MR Imaging System.
The Transmit/Receive Body Imaging Coil is intended for imaging of the Neck, Spine, Abdomen/Thorax and the extremities.
Comparison with Predicate Device:
The Signa® 3.0T Magnetic Resonance System is a modification of the 3.0T Signa® VH/i MR system (K990550) by combining the 3.0T Signa® VH/i T/R Body Imaging Coil (K003613) with the 3.0T Signa® VH/i MR system (K990550). It has the same basic technological characteristics, and, uses the
Image /page/0/Picture/18 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' intertwined within a circular border. The letters and the border are black, creating a strong contrast against the white background.
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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 circular border. The letters and the border are black, creating a strong contrast against the white background.
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General Electric Company P.O. Box 414, Milwaukee, WI 53201
same basic design, construction, and materials. It has the same intended use, and operating modes as the predicate device.
Summary of Studies:
Testing was performed to demonstrate that the design modifications to the Signa® 3.0T MR System meet predetermined acceptance criteria.
Conclusion:
The results of the testing described above demonstrate that the Signa® 3.0T MR System is substantially equivalent to the currently cleared 3.0T Signa® VH/i transmit/Receive Body Imaging Coil and the 3.0 T Signa® VH/i system magnetic resonance system.
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three parallel lines forming the snake. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 2 2 2002
Larry Kroger, Ph.D. Regulatory Affairs Manager GE Medical Systems P.O. Box 414 MILWAUKEE WI 53201
Re: K022397
Trade/Device Name: GE Signa® 3.0T MR system Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device
Regulatory Class: II Product Code: 90 LNH Dated: July 18, 2002 Received: July 23, 2002
Dear Dr. Kroger:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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 (Act) that do not require approval of a premarket approval application (PMA). 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 (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 comply 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 forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation 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
510(k) Number (if known): _ KO22397
Device Name: GE Signa® 3.0T Magnetic Resonance System
Indications For Use:
The indications for use for the 3.0T Signa®VH/i (Signa® 3.0T MR System) Transmit/Receive Body Imaging Coil expands the imaging capability of the 3.0T Signa®VH/i MR Imaging System.
The Transmit/Receive Body Imaging Coil is intended for imaging of the Neck, Spine, Abdomen/Thorax and the extremities.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | ✓ | OR | Over-The-Counter Use | |
|---|---|---|---|---|
| (Per 21 CFR 801.109) |
Nancy hogdon
| (Division Sign-Off) | |
|---|---|
| Division of Reproductive, Abdominal, and Radiological Devices | |
| 510(k) Number | K022397 |