Discovery MR750 3.0T; Discovery MR750w 3.0T;Discovery MR450 1.5T; Discovery MR450w 1.5T; SIGNA Architect and SIGNA Artist

Q: Who is the manufacturer of Discovery MR750 3.0T; Discovery MR750w 3.0T;Discovery MR450 1.5T; Discovery MR450w 1.5T; SIGNA Architect and SIGNA Artist?

Ge Medical Systems, LLC filed the 510(k) submission for Discovery MR750 3.0T; Discovery MR750w 3.0T;Discovery MR450 1.5T; Discovery MR450w 1.5T; SIGNA Architect and SIGNA Artist (K163331).

Q: What is the FDA product code for Discovery MR750 3.0T; Discovery MR750w 3.0T;Discovery MR450 1.5T; Discovery MR450w 1.5T; SIGNA Architect and SIGNA Artist?

LNH. It is classified under 21 CFR 892.1000 as a Class 2 device in the Radiology panel.

Q: What is the regulatory pathway for Discovery MR750 3.0T; Discovery MR750w 3.0T;Discovery MR450 1.5T; Discovery MR450w 1.5T; SIGNA Architect and SIGNA Artist?

510(k) clearance (submission type: Traditional).

Q: What are the predicate devices for Discovery MR750 3.0T; Discovery MR750w 3.0T;Discovery MR450 1.5T; Discovery MR450w 1.5T; SIGNA Architect and SIGNA Artist?

Discovery MR750 3.0T (K160618); Discovery MR450 1.5T (K160618); Discovery MR750w 3.0T (K160618); Optima MR450w 1.5T (K160618); SIGNA Architect (K160618); SIGNA Artist (K160618).

Q: Who can help prepare an FDA 510(k) submission like Discovery MR750 3.0T; Discovery MR750w 3.0T;Discovery MR450 1.5T; Discovery MR450w 1.5T; SIGNA Architect and SIGNA Artist?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

K163331 · Ge Medical Systems, LLC · LNH · Mar 17, 2017 · Radiology

Device Facts

Record ID	K163331
Device Name	Discovery MR750 3.0T; Discovery MR750w 3.0T;Discovery MR450 1.5T; Discovery MR450w 1.5T; SIGNA Architect and SIGNA Artist
Applicant	Ge Medical Systems, LLC
Product Code	LNH · Radiology
Decision Date	Mar 17, 2017
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.1000
Device Class	Class 2

Intended Use

The SIGNA Architect, SIGNA Artist, Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T and the Optima MR450w 1.5T systems are whole body magnetic resonance scanners designed to support 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, TMI, 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 SIGNA Architect, SIGNA Artist, Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T and the Optima MR450w 1.5T systems reflect the spatial distribution or molecular environment of nuclei exhibiting magnetic resonance. These images and/or spectra when interpreted by a trained physician vield information that may assist in diagnosis.

Device Story

Whole-body MR scanners using superconducting magnets, time-varying magnetic field gradients, and RF transmissions to acquire MR signals. Data acquisition system supports up to 128 independent receive channels. Systems generate axial, sagittal, coronal, oblique, and double-oblique images, spectroscopic images, and parametric maps. Operated by trained professionals in clinical settings. Software features (MAGIC DWI, CardioMaps) process raw MR data to produce diagnostic images/maps. Output interpreted by physicians to assist in diagnosis of anatomical structures and functions. Benefits include high signal-to-noise ratio and reduced scan times.

Clinical Evidence

No clinical data provided. Evidence consists of non-clinical bench testing, including phantom testing for Synthetic DWI and CardioMaps, and submission of sample clinical images. Compliance with AAMI/ANSI 62304, AAMI/ANSI ES60601-1, and IEC 60601-2-33 standards confirmed.

Technological Characteristics

Superconducting magnet MR system; 128-channel data acquisition; NEMA DICOM standard compliance. Software-based image reconstruction and processing (MAGIC DWI, CardioMaps). Complies with IEC 60601-2-33, AAMI/ANSI ES60601-1, and AAMI/ANSI 62304.

Indications for Use

Indicated for whole-body diagnostic MR imaging (head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints, prostate, vasculature, musculoskeletal) to produce images, spectra, and parametric maps for physician interpretation. Applicable to all patient populations requiring MR imaging; contrast agents may be used.

Regulatory Classification

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).

Special Controls

*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.

Predicate Devices

Discovery MR750 3.0T (K160618)
Discovery MR450 1.5T (K160618)
Discovery MR750w 3.0T (K160618)
Optima MR450w 1.5T (K160618)
SIGNA Architect (K160618)
SIGNA Artist (K160618)

Related Devices

K132376 — DISCOVERY MR750 3.0T, DISCOVERY MR450 1.5T, DISCOVERY MR750W 3.0T, OPTIMA MR450W 1.5T · Ge Healthcare (Ge Medical Systems, LLC) · Nov 15, 2013
K142085 — DISCOVERY MR750 3.0T ,DISCOVERY MR450 1.5T, DISCOVERY MR750 3.0T,OPTIMA MR450W 1.5T · Ge Medical Systems, LLC · Sep 26, 2014
K091536 — OPTIMA MR450W · Ge Medical Systems, LLC · Jul 17, 2009
K130115 — DISCOVERY MR750W 3.0T · Ge Medical Systems, LLC · May 23, 2013
K211980 — SIGNA Prime · Ge Healthcare (Tianjin) Company Limited · Jan 16, 2022

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the circle is an abstract symbol that resembles a stylized caduceus, with three human profiles facing to the right. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 March 17, 2017 GE Medical Systems, LLC % Mary A Mayka, Ph.D. Regulatory Affairs Manager 3200 Grandview Blvd. WAUKESHA WI 53188 Re: K163331 Trade/Device Name: SIGNA Architect. SIGNA Artist. Discovery MR750 3.0T. Discovery MR450 1.5T, Discovery MR750w 3.0T and the Optima MR450w 1.5T Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH Dated: February 17, 2017 Received: February 21, 2017 Dear Dr. Mayka: 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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. {1}------------------------------------------------ If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/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 Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours. Michael D'Hara For Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use #### 510(k) Number (if known) K163331 . Device Name SIGNA Architect, SIGNA Artist, Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T and the Optima MR450w 1.5T #### Indications for Use (Describe) The SIGNA Architect, SIGNA Artist, Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T and the Optima MR450w 1.5T systems are whole body magnetic resonance scanners designed to support 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, TMI, 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 SIGNA Architect, SIGNA Artist, Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T and the Optima MR450w 1.5T systems reflect the spatial distribution or molecular environment of nuclei exhibiting magnetic resonance. These images and/or spectra when interpreted by a trained physician vield information that may assist in diagnosis. Type of Use (Select one or both, as applicable) | | X Prescription Use (Part 21 CFR 801 Subpart D) | |--|------------------------------------------------------------------| | | Over-The-Counter Use (21 CFR 801 Subpart C) | ## CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ Image /page/3/Picture/1 description: The image shows the logo for General Electric (GE). The logo is a blue circle with the letters "GE" in a stylized font in the center. The circle is surrounded by a decorative border of curved lines. The logo is simple and recognizable, and it is associated with a well-known and established company. Section 05: 510(k) Summary Discovery MR750w 3.0T, Discovery MR750 3.0T, Optima MR450w 1.5T, Discovery MR450 1.5T, SIGNA Architect, SIGNA Artist {4}------------------------------------------------ Image /page/4/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' written in a stylized script, enclosed within a blue circle. There are also white droplet-like shapes surrounding the circle, giving it a dynamic and fluid appearance. The logo is simple, recognizable, and represents the multinational conglomerate corporation. | In accordance with 21 CFR 807.92 the following summary of information is provided: | | | |------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--| | Date: | November 22, 2016 | | | Primary Contact Person: | Mary A. Mayka, Ph.D. Regulatory Affairs Manager GE Healthcare Phone: 262-527-3148 Fax: 262-364-2785 | | | Secondary Contact Person: | Glen Sabin Regulatory Affairs Director, MR GE Healthcare, (GE Medical Systems, LLC) Phone: 262-521-6848 Fax: 414-908-9585 | | | Device Trade Name: | Discovery MR750w 3.0T, Discovery MR750 3.0T, Optima MR450w 1.5T, Discovery MR450 1.5T, SIGNA Architect, SIGNA Artist | | | Common/Usual Name: | Magnetic Resonance Diagnostic Device | | | Classification Names: | Magnetic Resonance Diagnostic Device (21 CFR 892.1000) | | | Product Code: | LNH | | | Predicate Devices: | K160618: Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T, Optima MR450w 1.5T, SIGNA Architect, SIGNA Artist | | | Device Description: | The Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T, Optima MR450w 1.5T, SIGNA Architect and SIGNA Artist systems are whole body magnetic resonance scanners designed to support high resolution, high signal-to-noise ratio, and short scan times. The systems each feature a superconducting magnet. The data acquisition system accommodates up to 128 independent receive channels in various increments and multiple independent coil elements per channel during a single acquisition series. Each 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. Each system can image in the sagittal, coronal, axial, oblique, and double oblique planes, using various pulse sequences and reconstruction algorithms. The Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T, Optima MR450w 1.5T, SIGNA Architect. SIGNA Artist systems are designed to conform to | | {5}------------------------------------------------ Image /page/5/Picture/1 description: The image shows the logo for General Electric (GE). The logo consists of the letters 'GE' in a stylized, cursive font, enclosed within a circular border. The space between the letters and the border is filled with a light blue color. The logo is simple and recognizable, representing the company's brand identity. | | NEMA DICOM standards (Digital Imaging and Communications in Medicine). | |----------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | The original description hasn't changed from predicate devices (K160618), other than reflecting the additional receive channels available. The modifications to these systems include the MAGIC DWI and CardioMaps software features, delivered via the DV26 program. The proposed software features will be ported over to other GE Healthcare MR systems based on appropriate design controls and evaluation of the change in accordance with FDA's Guidance—Deciding When to Submit a 510(k) for a Change to an Existing Device. | | Indications for Use: | The SIGNA Architect, SIGNA Artist, Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T and the Optima MR450w 1.5T systems are whole body magnetic resonance scanners 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 SIGNA Architect, SIGNA Artist, Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T and the Optima MR450w 1.5T systems reflect 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. | | Comparison of Intended Use | The addition of the proposed software features does not impact the indications for use. The indications for use have not changed, other than the addition of the SIGNA Architect and SIGNA Artist systems (K160618/001 and K160618/002). Therefore, the intended use is the same as the predicate device in accordance with the FDA's guidance document "The 510(k) Program: Evaluating Substantial Equivalence in | | Comparison of Technological Characteristics: | The MR systems with the proposed software features employ the same fundamental technology as the predicate devices. | | Performance Data: | Summary of Non-Clinical Tests: The changes are software only features and comply with the following voluntary standards: • AAMI/ANSI 62304 • AAMI/ANSI ES60601-1 • IEC 60601-2-33 | | | The following quality assurance measures were applied to the development of the device: • 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) | | | The non-clinical tests have been summarized in this 510(k). Phantom testing for both Synthetic DWI and CardioMaps was completed to demonstrate acceptable performance. Testing was completed with passing results per the pass/fail criteria defined in the test cases. This supports substantial equivalence to its predicates because it was also developed under quality assurance Design Controls. Summary of Clinical Tests: | | | Sample clinical images are included in this submission in accordance with the MR guidance on premarket notification submissions. | | Conclusion: | The GE MR systems with the modified software features have the same intended use as the predicate. This 510(k) submission includes information on the technological characteristics of the proposed software features, as well as performance data demonstrating that the features are as safe and effective as the predicate, and does not raise different questions of safety and effectiveness. | | | In conclusion, GE Healthcare believes that the MR systems with the modified software features are substantially equivalent to the predicate devices. | {6}------------------------------------------------ Image /page/6/Picture/1 description: The image shows the logo for General Electric (GE). The logo is a blue circle with the letters "GE" in a stylized font in the center. The circle is surrounded by a series of curved lines that resemble water droplets or splashes. The logo is simple and recognizable, and it is often used to represent the company's brand.