(21 days)
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on hardware modifications and standard MR imaging principles.
No
The device is described as a "diagnostic imaging device" used to produce images for "determining diagnosis," and not for treating conditions.
Yes
The "Intended Use / Indications for Use" section explicitly states, "The Signa Ovation system is indicated for use as a diagnostic imaging device..." and later mentions that the images "provide information that can be useful in determining diagnosis."
No
The device description explicitly states it is a modification to an existing MR system and includes the addition of a "flexible extra large body coil," which is a hardware component.
Based on the provided information, the Signa Ovation system is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Signa Ovation Function: The Signa Ovation is a magnetic resonance imaging (MRI) system. It produces images of the internal structures of the body by using magnetic fields and radio waves. This is an in vivo (within the living body) diagnostic method, not an in vitro method.
- Intended Use: The intended use clearly states it's a "diagnostic imaging device to produce transverse, sagittal, coronal and oblique images of the internal structures and organs of the entire body." This describes an imaging modality, not a test performed on a sample outside the body.
Therefore, the Signa Ovation system falls under the category of medical imaging devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The Signa Ovation (formerly known as MFO/I) system is an open, whole body scanner designed to support improved higher resolution imaging and shorter scan times. The Signa Ovation 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 musculocskeletal, vascular, cardiac, and neuro systems. The images produced by the Signa Ovation 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 diagnosis.
Due to the 'open' design of the system, the Signa Ovation may also be used for imaging during interventional procedures when performed with MR compatible devices such as, in-room display, and MR safe biopsy needles.
Product codes
90 MOS
Device Description
The Extra Large Body Coil is a modification to the Signa MFO/i MR System (K002611) which includes the addition of a flexible extra large body coil.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance
Anatomical Site
internal structures and organs of the entire body, including, but not limited to, the musculocskeletal, 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
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Testing was performed to demonstrate that the design modifications to the Extra Large Body Coil meet predetermined acceptance criteria.
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
Image /page/0/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" in a stylized font, enclosed within a circle. There are decorative swirls or flourishes around the circle, adding to the logo's design. The logo is black and white.
Page 1 of 2
GE Medical Systems
General Electric Company P.O. Box 414, Milwaukee, WI 53201
510(k) Summary
K02342
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- 548-4768 |
| Date Prepared: | October 8 2002 |
Device Name:
Signa Ovation with Extra Large Body Coil Magnetic Resonance Coil, 21 CFR 892.1000, 90-MOS
Marketed Device:
The Signa Ovation system with Extra Large Body Coil is substantially equivalent to the currently marketed GE Signa MFO/i MR system (K002611).
Device Description:
The Extra Large Body Coil is a modification to the Signa MFO/i MR System (K002611) which includes the addition of a flexible extra large body coil.
Indications for Use:
The Signa Ovation (formerly known as MFO/I) system is an open, whole body scanner designed to support improved higher resolution imaging and shorter scan times. The Signa Ovation 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 musculocskeletal, vascular, cardiac, and neuro systems. The images produced by the Signa Ovation 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 diagnosis.
Due to the 'open' design of the system, the Signa Ovation may also be used for imaging during interventional procedures when performed with MR compatible devices such as, in-room display, and MR safe biopsy needles.
1
Image /page/1/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" intertwined and enclosed within a circular border. The letters and the border are in black, contrasting with the white background. The logo is a well-known symbol representing the multinational conglomerate.
General Electric Company P.O. Box 414, Milwaukee, WI 53201
Comparison with Predicate Device:
GE Medical Systems intends to begin marketing the Signa Ovation with Extra Large Body Coil. The Extra Large Body Coil is a modification of the Signa MFO/i MR System (K002611) with the main differences being the addition of a flexible extra large body coil. Signa MFO/i MR System has the same basic technological characteristics, and, uses similar design, construction, and materials.
Summary of Studies:
Testing was performed to demonstrate that the design modifications to the Extra Large Body Coil meet predetermined acceptance criteria.
Conclusion:
It is the opinion of GE that the Signa Ovation with Extra Large Body Coil is substantially equivalent to the GE Signa MFO/i MR System (K002611). Usage of the Extra Large Body Coil does not result in any new potential hazards.
2
Image /page/2/Picture/1 description: The image shows a black and white logo. The logo features a stylized bird with three curved lines representing its wings or feathers. The bird is facing to the right. The words "DEPARTMENT OF" are written vertically along the left side of the logo, following the curve of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
・、
5 2002 NOV
Larry Kroger, Ph.D. Regulatory Programs Manager GE Medical Systems General Electric Company P.O. Box 414 MILWAUKEE WI 53201
Re: K023442
Trade/Device Name: Extra Large Body Coil Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II
Product Code: 90 MOS Dated: October 8, 2002 Received: October 15, 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. Brydon
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): KO234 + 2
Device Name: Extra Large Body Coil
Indications For Use:
The Signa Ovation (formerly known as MFO/I) system is an open, whole body scanner designed to support improved higher resolution imaging and shorter scan times. The Signa Ovation 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 musculocskeletal, vascular, cardiac, and neuro systems. The images produced by the Signa Ovation 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 diagnosis.
Due to the 'open' design of the system, the Signa Ovation may also be used 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)
Prescription Use (Per 21 CFR 801.109)
Over-The-Counter Use OR
David G. Ingram
ological Devic