(14 days)
No
The summary describes standard MR imaging techniques (Fourier transformation) and does not mention AI, ML, or related concepts.
No
The device is explicitly described as a "diagnostic imaging device" intended to produce images for "determining a diagnosis," not for therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states, "The Signa® Profile EXCITE MR system is indicated for use as a diagnostic imaging device." It also mentions that the images "provide information that can be useful in determining a diagnosis."
No
The device description explicitly states it is a "whole body scanner" and "utilizes a permanent magnet," indicating it is a hardware system, 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, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Device Function: The Signa® Profile EXCITE MR system is an imaging device that uses magnetic resonance to produce images of the internal structures of the body. It does not analyze samples 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.
Therefore, based on the provided information, the Signa® Profile EXCITE MR system falls under the category of in vivo diagnostic imaging devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The Signa® Profile EXCITE MR system is an open, whole body scanner designed to support improved higher resolution imaging and shorter scan times. The Signa® Profile EXCITE MR 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 musculoskeletal, vascular, cardiac, and neuro systems. The images produced by the Signa® Profile EXCITE MR 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® Profile EXCITE MR system may also be utilized 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
Signa® Profile EXCITE MR System is a modification to the 0.2T Signa® Profile/i MR System (K033168) which utilizes a permanent magnet to acquire 2D single-slice and multi-slice, and 3D volume images. 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
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
entire body, including, but not limited to, the musculoskeletal, 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The Signa® Profile EXCITE MR System was evaluated to the appropriate NEMA performance standards as well as the IEC 60601-1 International Medical Equipment Safety standard and IEC 60601-2-33 Particular Requirements for Safety of Magnetic Resonance Equipment for Medical Diagnosis. The Signa® Profile EXCITE MR System is comparable to the currently marketed Signa® Profile/i MR 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
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 the General Electric (GE) logo. The logo consists of the letters 'GE' intertwined within a circular border. The letters and the border are in white, set against a black background, creating a high-contrast and recognizable design.
General Electric Company P.O. Box 414, Milwaukee, WI 53201
14043112
NOV 2 4 2004 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 Healthcare
PO Box 414
Milwaukee, WI 53201 |
|-----------------|-------------------------------------------------------------|
| Contact Person: | Larry A. Kroger Ph.D.
Senior Regulatory Programs Manager |
| Telephone: | 262- 544-3894 |
| Fax: | 262- 548-4768 |
| Date Prepared: | November 8, 2004 |
Device Name:
Signa® Profile EXCITE MR System Magnetic Resonance Diagnostic System, 21 CFR 892.1000, 90-LNH
Marketed Device:
Signa® Profile EXCITE MR System is substantially equivalent to the currently marketed the 0.2T Signa® Profile/i MR system (K033168) with the main differences of EXCITE technology with change of data acquisition hardware, host computer operated by new version software, and gradient power supply to AN8295Y, which enable maximum gradient slew rate changes to 34 T/m/s with maximum hardware capability of 46 T/m/s to allow for future customer upgrades. Maximum gradient amplitude is 19 mT/m.
Device Description:
Signa® Profile EXCITE MR System is a modification to the 0.2T Signa® Profile/i MR System (K033168) which utilizes a permanent magnet to acquire 2D single-slice and multi-slice, and 3D volume images. 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
Indications for Use:
The Signa® Profile EXCITE MR system is an open, whole body scanner designed to support imb olgha Frome Broting and shorter scan times. The Signa® Profile EXCITE MR 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 musculoskeletal, vascular, cardiac, and neuro systems. The images produced by the Signa® EXCITE MR 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
1
Image /page/1/Picture/0 description: The image shows the General Electric (GE) logo. The logo is a circular emblem with the letters 'GE' intertwined in the center. The letters are stylized and appear to be handwritten or calligraphic. The logo is black and white.
General Flectric Comnany P.O. Box 414, Milwaukee, WI 53201
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® Profile EXCITE MR system may also be utilized 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® Profile EXCITE MR System is a modification of the Signa® Profile/i MR System (K033168) with the main differences of EXCITE technology with change of data acquisition hardware, host computer operated by new version software, and gradient power supply to AN8295Y. which enable maximum gradient slew rate changes to 34 T/m/s with maximum hardware capability of 46 T/m/s to allow for future customer upgrades. The Maximum gradient amplitude is 19 mT/m.
Summary of Studies:
The Signa® Profile EXCITE MR System was evaluated to the appropriate NEMA performance standards as well as the IEC 60601-1 International Medical Equipment Safety standard and IEC 60601-2-33 Particular Requirements for Safety of Magnetic Resonance Equipment for Medical Diagnosis. The Signa® Profile EXCITE MR System is comparable to the currently marketed Signa® Profile/i MR System.
Conclusion:
It is the opinion of GE that the Signa® Profile EXCITE MR System is substantially equivalent to the Signa® Profile/i MR System. Usage of the Signa® Profile EXCITE MR System does not 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 - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. Inside the circle is an abstract image of an eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 2 4 2004
Larry A. Kroger, Ph.D. Senior Regulatory Programs Manager General Electric Company GE Healthcare P.O. Box 414, W-400 MILWAUKEE WI 53201
Re: K043112 Trade/Device Name: GE 0.2T Signa® Profile EXCITE MR System Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device
Regulatory Class: II Product Code: 90 LNH Dated: November 8, 2004 Received: November 10, 2004
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 (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 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) r ms lotter notification. The FDA finding of substantial equivalence of your device to a legally prematicate 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 rr you atter Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) 240-276-0115 | |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). You may obtain other general information on your responsibilities under the Act 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 General Electric (GE) logo. The logo consists of the letters "GE" intertwined and enclosed within a circular shape. The letters and the circle are in black, creating a strong contrast. The logo is simple, recognizable, and represents the General Electric brand.
GE Healthcare
General Electric Company P.O. Box 414, Milwaukee, WI 53201
STATEMENT OF INTENDED USE
K043112 510(k) Number (if known):
| Device Name: | GE 0.2T Signa ® Profile EXCITE MR System |
|---|---|
| -------------- | ----------------------------------------------------- |
Indications for Use
The Signa® Profile EXCITE MR system is an open, whole body scanner designed to support improved higher resolution imaging and shorter scan times. The Signa® Profile EXCITE MR 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 musculoskeletal, vascular, cardiac, and neuro systems. The images produced by the Signa® Profile EXCITE MR 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® Profile EXCITE MR system may also be utilized for imaging during interventional procedures when performed with MR compatible devices such as, in-room display and MR safe biopsy needles.
Nancy Brogdon
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number [K043112](https://510k.innolitics.com/search/K043112)
(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