(20 days)
Not Found
No
The document describes standard MRI technology and image reconstruction techniques (Fourier transformation) without mentioning AI or ML.
No
The device is described as a "diagnostic imaging device" whose images provide information "useful in determining a diagnosis," not for therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states, "The Signa 0.35T Signa® Ovation with Excite Magnetic Resonance System is indicated for use as a diagnostic imaging device".
No
The device description clearly outlines a physical Magnetic Resonance System with a permanent magnet, indicating it is a hardware device, not software-only.
Based on the provided information, this device 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.
- Device Function: The description clearly states that the 0.35T Signa® Ovation with Excite Magnetic Resonance System is a diagnostic imaging device that produces images of the internal structures and organs of the entire body. It works by utilizing magnetic resonance properties of protons within the body.
- No Sample Analysis: There is no mention of this device analyzing samples taken from the body. It directly images the body itself.
Therefore, this device falls under the category of in vivo diagnostic imaging equipment, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The 0.35T Signa ®Ovation with Excite Magnetic Resonance System is an open, whole body scanner designed to support improved higher resolution imaging and shorter scan times. The 0.35T Signa® Ovation with Excite Magnetic Resonance 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 0.35T Signa ®Ovation with Excite 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 (comma separated list FDA assigned to the subject device)
90 LNH
Device Description
The 0.35T Signa ®Ovation with Excite Magnetic Resonance System is a modification to the 0.35T Signa® MFO/i Magnetic Resonance System (K002611) which utilizes a permanent magnet to acquire 2D single-slice and multi-slice, and 3D volume images. The 0.35T Signa ®Ovation with Excite Magnetic Resonance System features a permanent magnet operating at 0.35T. The system can image in the sagittal, coronal, axial, oblique and double oblique planes, using various pulse sequences. Images are acquired and reconstructed using 2D and 3D Fourier transformation techniques. The system is intended for high-resolution anatomical applications, short scan times, and multinuclear spectroscopy.
Mentions image processing
Yes
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 / 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 0.35T Signa® Ovation with Excite Magnetic Resonance 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 Safety of Magnetic Resonance Equipment for Medical Diagnosis. The 0.35T Signa® Ovation with Excite Magnetic Resonance System is comparable to the currently marketed Signa® 0.35T Ovation Magnetic Resonance System.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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.
Not Found
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
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- 548-4768 |
| Date Prepared: | November 4, 2003 |
Device Name:
GE 0.35T Signa ®Ovation with Excite Magnetic Resonance System Magnetic Resonance Diagnostic System, 21 CFR 892.1000, 90-LNH
Marketed Device:
The GE 0.35T Signa ®Ovation with Excite MR System is substantially equivalent to the currently marketed Signa® 0.35T MFO/i MR System (K002611) with the main differences being an addition of four independent receive channels and an update to the performance of the gradient amplifiers.
Device Description:
The 0.35T Signa ®Ovation with Excite Magnetic Resonance System is a modification to the 0.35T Signa® MFO/i Magnetic Resonance System (K002611) which utilizes a permanent magnet to acquire 2D single-slice and multi-slice, and 3D volume images. The 0.35T Signa ®Ovation with Excite Magnetic Resonance System features a permanent magnet operating at 0.35T. The system can image in the sagittal, coronal, axial, oblique and double oblique planes, using various pulse sequences. Images are acquired and reconstructed using 2D and 3D Fourier transformation techniques. The system is intended for high-resolution anatomical applications, short scan times, and multinuclear spectroscopy.
Indications for Use:
The 0.35T Signa ®Ovation with Excite Magnetic Resonance System is an open, whole body scanner designed to support improved higher resolution imaging and shorter scan times. The 0.35T Signa® Ovation with Excite Magnetic Resonance 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 0.35T Signa ®Ovation with Excite 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
1
Image /page/1/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' intertwined within a circular frame. The letters are stylized and connected, giving the logo a distinctive and recognizable appearance. The logo is in black and white.
General Electric Company P.O. Box 414, Milwaukee, WI 53201
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 0.35T Signa® Ovation with Excite 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
Comparison with Predicate Device:
The GE 0.35T Signa® Ovation with Excite MR System is a modification of the Signa® MFO/i MR system (K002611) with the main differences being the addition of Excite Technology and the addition of the improved gradient performance.
Summary of Studies:
The 0.35T Signa® Ovation with Excite Magnetic Resonance 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 Safety of Magnetic Resonance Equipment for Medical Diagnosis. The 0.35T Signa® Ovation with Excite Magnetic Resonance System is comparable to the currently marketed Signa® 0.35T Ovation Magnetic Resonance System.
Conclusion:
It is the opinion of GE that the 0.35T Signa® Ovation with Excite Magnetic Resonance System is substantially equivalent to the Signa® 0.35T MFO/i Magnetic Resonance System. Usage of the 0.35T Signa® Ovation with Excite Magnetic Resonance System does not result in any new potential hazards.
2
Image /page/2/Picture/1 description: The image is a black and white circular logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a stylized emblem. The emblem consists of three overlapping human profiles facing to the right, with flowing lines beneath them, resembling a stylized representation of people and movement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 2 5 2003
Larry A. Kroger, Ph.D. Senior Regulatory Programs Manager GE Medical Systems P.O. Box 414, W-400 MILWAUKEE WI 53201
Re: K033504 Trade/Device Name: GE 0.35T Signa® Ovation with Excite MR System Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance imaging system Regulatory Class: II Product Code: 90 LNH Dated: November 4, 2003 Received: November 5, 2003
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 such 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 Section 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 the 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" (21CFR Part 807.97) you may obtain. 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
Image /page/4/Picture/0 description: The image shows the text "GE Medical Systems" in a bold, sans-serif font. The text is arranged on a single line, with each word clearly legible. The overall impression is clean and professional, suggesting a corporate identity.
General Electric Company P.O. Box 414, Milwaukee, WI 53201
STATEMENT OF INTENDED USE
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: GE 0.35T Signa® Ovation with Excite MR System
Indications for Use
The 0.35T Signa® Ovation with Excite Magnetic Resonance System is an open, whole body scanner designed to support improved higher resolution imaging and shorter scan times. The Signa 0.35T Signa® Ovation with Excite Magnetic Resonance 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 0.35T Signa® Ovation with Excite 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.
Due to the 'open' design of the Signa 0.35T Signa® Ovation with Excite 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
David H. Seymore
(Division Sign-Off) Division of Reproductive, Abdomin and Radiological Devices 510(k) Number
(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) OR
Over-The-Counter Use