(85 days)
Not Found
No
The summary describes standard MRI technology and image reconstruction techniques (Fourier transformation). There is no mention of AI, ML, or related concepts in the intended use, device description, or performance studies.
No
The device is clearly indicated for "diagnostic imaging" and "determining a diagnosis," not for therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states, "The Signa OpenSpeed Magnetic Resonance System is indicated for use as a diagnostic imaging device".
No
The device description clearly states it is a "Magnetic Resonance System" which includes a superconducting magnet and other hardware components for acquiring images. While it uses software for image acquisition and reconstruction, it is not solely software.
Based on the provided text, 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 Signa OpenSpeed Magnetic Resonance System is an imaging device that produces images of the internal structures and organs of the body using magnetic resonance. It does not analyze samples taken from the body.
- Intended Use: The intended use is for diagnostic imaging to produce images that, when interpreted by a trained physician, provide information useful in determining a diagnosis. This is a form of in vivo (within the living body) diagnostic imaging, not in vitro.
The description clearly indicates it's a whole-body scanner that images the internal structures directly, not by analyzing samples.
N/A
Intended Use / Indications for Use
The Signa OpenSpeed Magnetic Resonance System is an open, whole body scanner designed to support improved higher resolution imaging and shorter scan times. The Signa OpenSpeed 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 OpenSpeed 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, spinlattice 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 Signa OpenSpeed 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-LNH
Device Description
The Signa OpenSpeed Magnetic Resonance System is a modification to the Signa HFO/i Magnetic Resonance System (K992746) which utilizes a superconducting magnet to acquire 2D single-slice and multi-slice, and 3D volume images. The Signa OpenSpeed Magnetic Resonance System is an open style magnet operating at 0.7T. 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 and shorter scan times. Previously cleared software options, coils, and other accessories may be used with the Signa OpenSpeed Magnetic Resonance System.
Mentions image processing
Images are acquired and reconstructed using 2D and 3D Fourier transformation techniques.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance
Anatomical Site
The 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 Signa OpenSpeed Magnetic Resonance System was evaluated to the appropriate NEMA The Signa Openspece Magnetic Robertanoon J. International Medical Equipment Safety standard and performance buildiana as as "rements for Safety of Magnetic Resonance Equipment for Medical IEC 001-2-53 I articular Nequilions for SReey of MSS. Somparable to the currently marketed Signa HFO/i Magnetic Resonance System.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
Image /page/0/Picture/0 description: The image shows a black and white logo. The logo is circular and contains two intertwined letters that appear to be "G" and "E". The logo is likely for General Electric (GE).
NOV 2 0 2001
Page 1 of 2
General Electric Company P.O. Box 414, Milwaukee, WI 53201
510(K) SUMMARY
Ko12875
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: | August 23, 2001 |
Device Name:
GE Signa OpenSpeed Magnetic Resonance System Magnetic Resonance Diagnostic System, 21 CFR 892.1000, 90-LNH
Marketed Device:
The Signa OpenSpeed Magnetic Resonance System is substantially equivalent to the currently marketed The organ of Magnetic Resonance System (K992746) with the main differences being an increase in gradient strength from 15mT/m, and an increase in slew rate from SR25 to SR40. In addition, Diffusion imaging is now offered as an imaging option.
Device Description:
The Signa OpenSpeed Magnetic Resonance System is a modification to the Signa HFO/i Magnetic Resonance System (K992746) which utilizes a superconducting magnet to acquire 2D single-slice and multi-slice, and 3D volume images. The Signa OpenSpeed Magnetic Resonance System is an open style magnet operating at 0.7T. 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 and shorter scan times. Previously cleared software options, coils, and other accessories may be used with the Signa OpenSpeed Magnetic Resonance System.
Indications for Use:
The Signa OpenSpeed Magnetic Resonance System is an open, whole body scanner designed to support improved higher resolution imaging and shorter scan times. The Signa OpenSpeed 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 OpenSpeed 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, spinlattice relaxation time (T1), spin-spin relaxation time (T2) and flow. When interpreted by a trained
1
Image /page/1/Picture/1 description: The image shows a circular logo with a stylized design. The logo appears to be a vintage or retro design, possibly representing a company or brand. The design consists of intertwined or overlapping elements within the circle, creating a visually complex and abstract pattern. The logo is black and white, with the design elements appearing in black against a white background.
Page 2 of 2
General Electric Company P.O. Box 414, Milwaukee, WI 53201
physician, these images provide information that can be useful in determining a diagnosis.
Due to the 'open' design of the system, the Signa OpenSpeed 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 Signa OpenSpeed Magnetic Resonance System is a modification of the Signa HFP/i MR system (K992746) with the main differences being an increase in gradient strength from 15mT/m, (1892140) with the main differences oong an more and and the maging is now offered as an imaging option.
Summary of Studies:
The Signa OpenSpeed Magnetic Resonance System was evaluated to the appropriate NEMA The Signa Openspece Magnetic Robertanoon J. International Medical Equipment Safety standard and performance buildiana as as "quirements for Safety of Magnetic Resonance Equipment for Medical IEC 001-2-53 I articular Nequilions for SReey of MSS. Somparable to the currently marketed Signa HFO/i Magnetic Resonance System.
Conclusion:
It is the opinion of GE that the Signa OpenSpeed Magnetic Resonance System is substantially equivalent it is the Signa HFO/i Magnetic Resonance System. The Signa OpenSpeed Magnetic Resonance System to the bight III Ori Haghetions for use, nor does use of this device result in any new potential hazards.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name encircling a stylized emblem. The emblem consists of a stylized caduceus, a symbol often associated with medicine and healthcare, with three lines representing the branches of government.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 2 0 2001
Larry Kroger, Ph.D. Regulatory Programs Manager GE Medical Systems General Electric Company P.O. Box 414 MILWAUKEE WI 53201
Re: K012875 Trade/Device Name: Signa OpenSpeed Magnetic
Resonance System Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: 90 LNH Dated: August 23, 2001 Received: August 27, 2001
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 nouthoution. The I Drivinention 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 If you done 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 Actively reliable 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 of reference to premainted from the 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. Snugden
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosures
4
NOV 2 0 2001
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Signa OpenSpeed Magnetic Resonance System
Indications For Use:
The Signa OpenSpeed Magnetic Resonance System is an open, whole body scanner designed to support improved higher resolution imaging and shorter scan times. The Signa OpenSpeed 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 OpenSpeed 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, spinlattice 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 OpenSpeed 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) | ✓ |
|---|---|
| --------------------------------------- | -------------------------------------------------------------------------------------------------------------- |
OR Over-The-Counter Use
Nancy brigton
Division Sign-Off
Division of Reproductive, Abdominal,
Radiological Devices
510(K) Number K012875