(105 days)
Not Found
No
The summary describes a standard MRI system and does not mention any AI or ML capabilities for image processing, analysis, or other functions.
No.
The device is indicated for use as a diagnostic imaging device to produce images for diagnosis, not for therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "indicated for use as a diagnostic imaging device." It also mentions that the images and/or spectra produced "when interpreted by a trained physician yield information that may assist in diagnosis."
No
The device description explicitly states it is a "whole body magnetic resonance system" and describes hardware components like magnetic fields, RF transmissions, and a data acquisition system. This is a hardware device with associated software, not a software-only medical device.
No, 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. They are used to analyze these samples outside of the body.
- Device Function: The description clearly states that the 1.5T Signa HDx family and 3.0T Signa HDx family are magnetic resonance scanners. These devices produce images of the internal structures and functions of the entire body while the patient is inside the scanner. This is an in vivo (within the living body) diagnostic imaging technique, not an in vitro test.
- Intended Use: The intended use is to produce images and/or spectra that, when interpreted by a trained physician, assist in diagnosis. This is consistent with diagnostic imaging, not laboratory testing of samples.
Therefore, based on the provided information, this device is a diagnostic imaging device, specifically an MRI scanner, and does not fit the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The 1.5T Signa HDx family and 3.0T Signa HDx family are a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. It is indicated for use as a diagnostic imaging device to produce axial, sagittal, coronal, and oblique images, spectroscopic images, parametric maps, and/or spectra, dynamic images of the structures and/or functions of the entire body, including, but not limited to. head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints, prostate, blood vessels, and musculoskeletal regions of the body. Depending on the region of interest being imaged, contrast agents may be used. The images produced by the 1.5T Signa HDx family and 3.0T Signa HDx family reflects the spatial distribution or molecular environment of nuclei exhibiting magnetic resonance. These images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis.
Product codes
LNH, MOS, LNI
Device Description
The 1.5T Signa HDx family and 3.0T Signa HDx family system are a whole body magnetic resonance system designed to support high resolution, high signal-to-noise ratio, and short scan times. The Signa HDx family of scanners is available in two different field strengths of 1.5T and 3.0T. The system uses a combination of time-varying magnetic fields (gradients) and RF transmissions to obtain information regarding the density and position of elements exhibiting magnetic resonance. The data acquisition system accommodates up to 32 independent receive channels in various increments and multiple independent coil elements per channel during a single acquisition series. The System can image axial, sagittal, coronal, and oblique anatomical images, spectroscopic data, parametric maps, or dynamic images of the structures or functions of the entire body.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance
Anatomical Site
entire body, including, but not limited to. head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints, prostate, blood vessels, and musculoskeletal regions of the 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
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 subject of this premarket submission, 1.5T Signa HDx family and 3.0T Signa HDx family did not require clinical studies to support substantial external equivalence. Internal scans were conducted as part of validation for workflow and image quality and that sample clinical images are included in the submission.
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 handwritten text. The top line reads "K121676". The bottom line reads "Page 1 of 3". The text appears to be a page number or identifier within a larger document.
SEP 20 2012
510(k) Summary
In accordance with 21 CFR 807.92 the following summary of information is provided:
| Date: | 25-May-2012 |
|---|---|
| Submitter: | GE Healthcare. (GE Medical Systems LLC) |
| 3200 N Grandview Blvd. | |
| Waukesha, WI 53188 USA | |
| Primary Contact Person: | Shashidhar C S |
| Regulatory Affairs Leader - MR | |
| GE Healthcare, | |
| Phone: +91-80-40883613 | |
| Secondary Contact Person: | Glen Sabin |
| Regulatory Affairs Director - MR | |
| GE Healthcare, | |
| Phone: (262) 521-6848 | |
| Fax: (262) 364-2785 | |
| Device / | |
| Trade Name: | 1.5T Signa HDx family and 3.0T Signa HDx family |
| Common /Usual Name: | Magnetic Resonance Imaging System |
| Classification Names: | Magnetic resonance diagnostic device |
| Product Code: | LNH |
| Predicate Device(s): | 1.5T and 3.0T Signa HDx MR System (K052293) |
| Discovery MR750w 3.0T (K103327) | |
| Device Description: | The 1.5T Signa HDx family and 3.0T Signa HDx family |
| systems are a whole body magnetic resonance system | |
| designed to support high resolution, high signal-to-noise | |
| ratio, and short scan times. The Signa HDx family of | |
| scanners is available in two different field strengths of | |
| 1.5T and 3.0T. The system uses a combination of time- | |
| varying magnetic fields (gradients) and RF transmissions | |
| to obtain information regarding the density and position of | |
| elements exhibiting magnetic resonance. The data | |
| acquisition system accommodates up to 32 independent | |
| receive channels in various increments and multiple |
1
K121676
page 2 of 3
independent coil elements per channel during a single acquisition series. The System can image axial, sagittal, coronal, and oblique anatomical images, spectroscopic data, parametric maps, or dynamic images of the structures or functions of the entire body.
- Intended Use: The 1.5T Signa HDx family and 3.0T Signa HDx family are a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. It is indicated for use as a diagnostic imaging device to produce axial, sagittal, coronal, and oblique images, spectroscopic images, parametric maps, and/or spectra, dynamic images of the structures and/or functions of the entire body, including, but not limited to. head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints, prostate, blood vessels, and musculoskeletal regions of the body. Depending on the region of interest being imaged, contrast agents may be used. The images produced by the 1.5T Signa HDx family and 3.0T Signa HDx family reflects the spatial distribution or molecular environment of nuclei exhibiting magnetic resonance. These images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis.
- Technology: The 1.5T Signa HDx family and 3.0T Signa HDx family employs the same fundamental scientific technology as its predicate devices.
Determination of Substantial Equivalence:
Summary of Non-Clinical Tests:
The 1.5T Signa HDx family and 3.0T Signa HDx family and its applications comply with voluntary standards, including IEC60601-1, IEC60601-2-33, IEC60601-1-1, IEC60601-1-2, IEC60601-1-4, IEC60601-1-6, ISO14971, ISO10993-1 and IEC62304.
The following quality assurance measures were applied to the development of the system:
2
Image /page/2/Picture/0 description: The image shows the text "K121676 Page 3 of 3". The text appears to be handwritten. The phrase "Page 3 of 3" indicates that this is the last page of a document.
- . Risk Analysis
- Requirements Reviews .
- Design Reviews .
- Testing on unit level (Module verification) .
- Integration testing (System verification) .
- Performance testing (Verification) .
- . Safety testing (Verification)
- Simulated use testing (Validation) .
Summary of Clinical Tests:
The subject of this premarket submission, 1.5T Signa HDx family and 3.0T Signa HDx family did not require clinical studies to support substantial external equivalence. Internal scans were conducted as part of validation for workflow and image quality and that sample clinical images are included in the submission.
Conclusion:
GE Healthcare considers the 1.5T Signa HDx family and 3.0T Signa HDx family to be as safe; as effective, and performance is substantially equivalent to the predicate device(s).
Image /page/2/Picture/14 description: The image shows the words "Section 5" in a simple, sans-serif font. The word "Section" is capitalized, and the number "5" is written out as a digit. The text is black against a white background.
3
Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
SEP 20 2012
Mr. C.S. Shashidhar Regulatory Affairs Leader GE Medical Systems LLC 3200 N. Grandview Blvd WAUKESHA WI 53188
Re: K121676
Trade/Device Name: 1.5T Signa HDx family and 3.0T Signa HDx family Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH, MOS, and LNI Dated: September 7, 2012 Received: September 11, 2012
Dear Mr. Shashidhar:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your Scellon 910(t) promised is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the Citilosure) to regarry management date of the Medical Device American County commerce phor to May 26, 1976, the encordance 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 You may, therefore, market the device, sourcements for annual registration, listing of general controls provisions of the rist labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into class II (Special Controls), it may be subject to such II your device is Classified (see above) into in affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Please oe auvised that I Dri s issuance of a read on a complies with other requirements of the Act
that FDA has made a determination that your device complies with other requ that IDA has made a dolorimmentin as administered by other Federal agencies. You must or any Federal Statutes and regulations and limited to: registration and listing (21)
comply with all the Act's requirements, including, but not limited to: researching of comply with an the Act 3 requirements, and 809); medical device reporting (reporting of
4
medical device-related adverse events) (21 CFR 803); and good manufacturing practice medical device related adverse ovality systems (QS) regulation (21 CFR Part 820). This letter requirements as set form in the quality -Jevice as described in your Section 510(k) premarket with anow you to begal mading of your device of your device to a legally marketed noticate 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 Parts 601) 70 11 you desire specific ad rice for your estic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to under the MDK regulation (27 Of RP Latv 900), Portal Problem/default.htm for the CDRH's Office
of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Tou thay obtain of Scherers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely Yours,
Janine M. Morris
Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
5
K121676 510(k) Number (if known):
Device Name: 1.5T Signa HDx family and 3.0T Signa HDx family
Indications for Use:
The 1.5T Signa HDx family and 3.0T Signa HDx family are a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. It is indicated for use as a diagnostic imaging device to produce axial, sagittal, coronal, and oblique images, spectroscopic images, parametric maps, and/or spectra, dynamic images of the structures and/or functions of the entire body, including, but not limited to, head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints, prostate, blood vessels, and musculoskeletal regions of the body. Depending on the region of interest being imaged, contrast agents may be used.
The images produced by the 1.5T Signa HDx family and 3.0T Signa HDx family reflects the spatial distribution or molecular environment of nuclei exhibiting magnetic resonance. These images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis.
Prescription Use X _ (Part 21 CFR 801 Subpart D) Over-The-Counter Use (Part 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
AND/OR
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Mashad D. Othman
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) Kia1676
Section 4