(21 days)
Not Found
No
The document describes a standard MRI system and does not mention any AI or ML capabilities.
No.
The device is described as a "diagnostic imaging device" used to produce images for "determining a diagnosis," rather than for treating a condition.
Yes
The "Intended Use / Indications for Use" section explicitly states, "The Signa TwinSpeed is indicated for use as a diagnostic imaging device."
No
The device is described as a "whole body scanner" and a "diagnostic imaging device" that produces images of internal structures. It also mentions incorporating gradient performance and having a patient aperture, all of which are hardware components of an MRI system. The description clearly indicates a physical medical device, not software only.
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 for diagnosis, monitoring, or screening.
- Device Function: The Signa 1.5T TwinSpeed 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 in vivo imaging, not in vitro analysis.
Therefore, based on the provided information, the Signa 1.5T TwinSpeed is a medical imaging device, not an IVD.
N/A
Intended Use / Indications for Use
The Signa 1.5T TwinSpeed Magnetic Resonance System is a whole body scanner designed for shorter scan times. The Signa TwinSpeed 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 TwinSpeed system reflect the spatial distribution of protons (hydrogen nucle) 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 Signa 1.5T TwinSpeed incorporates the Signa Horizon Cx (K962061) and the Signa CVMR Magnetic Resonance System (K980114) gradient performance into a single MR device with a 60 cm patient aperture. Previously cleared software options, coils, and other accessories may be used with the Signa 1.5T TwinSpeed.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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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
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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)
Testing was performed to demonstrate that the design modifications to the Signa 1.5T TwinSpeed meet predetermined acceptance criteria.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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).
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§ 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
AUG - 3 2001
GE Medical Systems
Page 1 of 2
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 12, 2001 |
Device Name:
GE Signa 1.5T TwinSpeed Magnetic Resonance System Magnetic Resonance Diagnostic System, 21 CFR 892.1000, 90-LNH
Marketed Device:
The Signa 1.5T TwinSpeed System is substantially equivalent to the currently marketed Signa CVMR Magnetic Resonance System (K980114) and the Signa Horizon Cx (K962061).
Device Description:
The Signa 1.5T TwinSpeed incorporates the Signa Horizon Cx (K962061) and the Signa CVMR Magnetic Resonance System (K980114) gradient performance into a single MR device with a 60 cm patient aperture. Previously cleared software options, coils, and other accessories may be used with the Signa 1.5T TwinSpeed.
Indications for Use:
The Signa 1.5T TwinSpeed Magnetic Resonance System is a whole body scanner designed for shorter scan times. The Signa TwinSpeed 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 TwinSpeed system reflect the spatial distribution of protons (hydrogen nucle) 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.
Comparison with Predicate Device:
The Signa TwinSpeed is a modification of the Signa CVMR MR system (K980114) by combining the gradient performance of the CVMR and Signa Horizon Cx (K962061) into a single MR device. It has
1
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 frame. The frame has a swirling or stylized design around the letters.
Page 2 of 2
General Electric Company P.O. Box 414, Milwaukee, WI 53201
the same basic technological characteristics, and, uses the 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 1.5T TwinSpeed meet predetermined acceptance criteria.
Conclusion:
The results of the testing described above demonstrate that the Signa 1.5T TwinSpeed is substantially equivalent to the currently cleared Signa CVMR and Signa Horizon Cx magnetic resonance systems.
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an emblem featuring three stylized lines that resemble an abstract bird or a symbol representing health and human services.
AUG - 3 2001
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Larry Kroger, Ph.D. Regulatory Programs Manager GE Medical Systems General Electric Company P.O. Box 414 MILWAUKEE WI 53201
Re: K012200
GE Signa 1.5T Twinspeed Magnetic Resonance System Dated: July 12, 2001 Received: July 13.2001 Regulatory Class: II 21 CFR 892.1000/Procode: 90 LNH
Dear Dr. Kroger:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the In introlleting in a mivalent (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 keve been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part I done requirements, as out the missections, the Food and Drug Administration (FDA) will verify such assumptions. Failure o comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4639. 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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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 vours
Nancy C. Bogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure (s)
3
510(k) Number (if known): __ Ko | 2 Z o O
Device Name: Signa 1.5T TwinSpeed
Indications For Use:
The Signa 1.5T TwinSpeed Magnetic Resonance System is a whole body scanner designed for shorter The ofgia The Signa TwinSpeed is indicated for use as a diagnostic imaging device to produce Scan times. The Digital, coronal and oblique images of the internal structures of the images transvarse, sugman and conquestem reflect the spatial distribution of protons (hydrogen nuclei) produced of the bigital will 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)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OR Over-The-Counter Use
Havid h. Siyamm
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Device 510(k) Number