← Product Code [LNH](/productcode/LNH) · K183621
# EMMA 1.5T MRI System (K183621)
_Time Medical Limited · LNH · Feb 22, 2019 · Radiology · SESE_
**Canonical URL:** https://fda.innolitics.com/device/K183621
## Device Facts
- **Applicant:** Time Medical Limited
- **Product Code:** [LNH](/productcode/LNH.md)
- **Decision Date:** Feb 22, 2019
- **Decision:** SESE
- **Submission Type:** Abbreviated
- **Regulation:** 21 CFR 892.1000
- **Device Class:** Class 2
- **Review Panel:** Radiology
## Indications for Use
The EMMA 1.5T MRI System is indicated for use as a magnetic resonance diagnostic device (MRDD) which produces transverse, sagittal, coronal and oblique cross-sectional images, and those display the internal structure and/or function of the head, body, or extremities. Depending on the region of interest, contrast agents may be used. These images when interpreted by trained physician yield information that may assist medical diagnosis.
## Device Story
The EMMA 1.5T MRI System is a 1.5T superconducting magnet MRI scanner used in clinical settings to produce cross-sectional images of the human body. It consists of a magnet, gradient coils, RF transmission/receive coils, patient table, and a Windows-based workstation running Prodiva software. The system operates by placing the patient in a strong magnetic field, exciting nuclei with RF signals, and acquiring relaxation signals via receiver coils. The spectrometer controls pulse sequences, while the workstation reconstructs raw data into images. Operators (technicians/radiologists) use the system to configure scans and manage data. The resulting images are interpreted by physicians to assist in medical diagnosis, providing anatomical and functional information to benefit patient care.
## Clinical Evidence
No formal clinical trials were conducted. Evidence consists of bench testing (biocompatibility per ISO 10993-1, electrical safety/EMC per IEC 60601-1/2-33, acoustic noise per NEMA MS 4-2010, and performance per NEMA MS-1, 2, 3, 5, 6, 8) and a comparison of sample clinical images between the subject and predicate devices to demonstrate consistent diagnostic image quality.
## Technological Characteristics
1.5T superconducting magnet system; materials include FRP and ABS. Components: gradient coils, RF transmission/receive coils, spectrometer, and multi-core PC workstation. Connectivity: DICOM compliant. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-33, NEMA MS series. Software: Prodiva (Windows-based).
## Regulatory 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
- SIGNA Voyager 1.5T ([K161567](/device/K161567.md))
## Submission Summary (Full Text)
> This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com.
>
> Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/).
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image contains two logos. The logo on the left is the Department of Health & Human Services - USA logo. The logo on the right is the FDA U.S. Food & Drug Administration logo. The FDA logo is blue.
Time Medical Limited % Mr. Nick Tse Compliance Manager G/F, Bio-Informatics Center No., 2 Science Park West Avenue Shatin, N.T., Hong Kong CHINA
February 22, 2019
Re: K183621
Trade/Device Name: EMMA 1.5T MRI System Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: Class II Product Code: LNH Dated: December 12, 2018 Received: December 26, 2018
Dear Mr. Tse:
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 mav, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be avare that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
{1}------------------------------------------------
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Michael D. O'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}------------------------------------------------
#### 2.2 INDICATIONS FOR USE
FDA Indications for Use Form (FDA Form 3881) is shown below and at Annex K.
| DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use | Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2020
See PRA Statement below. |
|------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------|
| 510(k) Number (if known) | |
| K183621 | |
| Device Name | |
EMMA 1.5T MRI System
#### Indications for Use (Describe)
The EMMA 1.5T MR System is a magnetic resonance diagnostic device (MRDD) which produces transverse, sagittal, coronal and oblique cross-sectional images, and those display the internal structure and/or function of the head, body, or extremities. Depending on the region of interest, contrast agents may be used. These images when interpreted by trained physician yield information that may assist medical diagnosis.
| Type of Use (Select one or both, as applicable) | | | | |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------|--|--|--|
| 2 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." | | | | |
FORM FDA 3881 (7/17)
Page 1 of 1
POC Fultidaing Services (301) 443-4345 EF
{3}------------------------------------------------
K183621
#### 2.1 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
This 510(k) Summary is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
| Date of Submission: | February, 9, 2018 |
|-------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Sponsor: | Time Medical Limited
G/F Bio-Informatics Centre, No. 2 Science Park West Avenue,
Hong Kong Science Park, Shatin, New Territories, Hong Kong, China
Contact Person: Nick Tse - Compliance Manager
Telephone number: +852 21561711 Fax.: +852 2156 0908 |
| Correspondent: | Time Medical Limited
G/F Bio-Informatics Centre, No. 2 Science Park West Avenue,
Hong Kong Science Park, Shatin, New Territories, Hong Kong, China
Contact Person: Nick Tse - Compliance Manager
Telephone number: +852 21561711 Fax.: +852 2156 0908 |
| Filing Device: | EMMA 1.5T MRI System |
| Classification Name: | System. Nuclear Magnetic Resonance Imaging |
| Regulatory Description: | Magnetic Resonance Diagnostic Device (MRDD) |
| Classification Class | Class II / LNH / 21 CFR 892. 1000 |
| Intended Use: | The EMMA 1.5T MRI System is indicated for use as a magnetic resonance
diagnostic device (MRDD) which produces transverse, sagittal, coronal and
oblique cross-sectional images, and those display the internal structure
and/or function of the head, body, or extremities. Depending on the region of
interest, contrast agents may be used. These images when interpreted by
trained physician yield information that may assist medical diagnosis. |
| Device Description: | The EMMA 1.5T MRI System is a 1.5T superconducting magnet MRI
system which produces transverse, sagittal, coronal and oblique
cross-sectional images, and those display the internal structure and/or
function of the head, body, or extremities. It is composed of Magnet, Magnet
Enclosure, Patient Table, Gradient Coil, Transmission Coil, Receiver Coil,
Client PC, and Imaging Cabinet. The system software, Prodiva, a
Windows-based software, is an interactive program with user friendly
interface. The device is conformed to IEC and DICOM standards. |
#### General Comparison to Predicate Device:
| Comparison Element | Filing Device: | Predicate Device: |
|---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | N/A | K161567 |
| Model | 15000-01 | SIGNA Voyager 1.5T |
| Device Name | EMMA 1.5T MRI System | SIGNA Voyager |
| Applicant | Time Medical Limited | GE Healthcare |
| Applicant Address | Unit G01-G03, 05 & 08, G/F,
Bio-Informatics Centre, Hong Kong
Science Park, Shatin, N.T | 3200 N. Grandview Blvd.
Waukesha, WI 53188, USA |
| Classification Name | System, Nuclear Magnetic
Resonance Imaging | Magnetic Resonance Diagnostic
Device |
| Product Code | LNH | LNH, MOS |
| Regulation Number | 21 CFR 892.1000 | |
| Panel | Radiology | |
| Class | Class II | |
| Indications for Use | The EMMA 1.5T MRI System is
indicated for use as a magnetic
resonance diagnostic device
(MRDD) which produces
transverse, sagittal, coronal and
oblique cross-sectional images,
and those display the internal
structure and/or function of the | The SIGNA Voyager is a whole body
magnetic resonance scanner
designed to support high resolution,
high signal-to-noise ratio, and short
scan time imaging. The SIGNA
Voyager is indicated for use as a
diagnostic imaging device to produce
axial, sagittal, coronal, and oblique |
{4}------------------------------------------------
The filing device has the same US FDA classification including classification name, product code, regulation number, panel, and class with the predicate device.
The filing device has the same major indications for use as the predicate device produces transverse, sagittal, coronal and oblique cross-sectional images, and those display the internal structure and/or function of the head, body, or extremities. Depending on the region of interest, contrast agents may be used. These images when interpreted by trained physician yield information that may assist medical diagnosis.
The minor differences in indications for use do not constitute any safety and effectiveness issue, as indicated in performance data provided.
| General | Filing Device | Predicate Device |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------|--------------------------------------------------|
| Design | Cylindrical | Cylindrical |
| Materials | FRP, ABS | |
| Power Source | Isolated power supply | |
| Performance Data | Comply with:
- NEMA MS standards
- IEC standards: IEC 60601-1,
IEC60601-1-2,
IEC60601-2-33 | |
| Magnet | Filing Device | Predicate Device |
| Type | Superconducting | |
| Field Strength | 1.5T | |
| Weight | 3,200 kg | 3,900 kg |
| Overall Dimensions | 1497 x 1880 x 2421 mm
(L x W x H) | 1730 x 2070 x 2360 mm
(L x W x H) |
| Cryogen Type | Liquid Helium | |
| Spatial Homogeneity | 1.45 ppm at 40 cm DSV | 0.40 ppm at 40 cm DSV |
| Fringe Field | 5 gauss line < 2.5m radial x 4m
axial | 2.5 m radial x 4.0 m axial |
| Magnet Room Lighting | For sufficient and even lighting, 16
overhead lamps (100 lumen each)
recommended | Available |
| Room Ventilation | HVAC is installed for ventilation. | |
| Gradient System | Filing Device | Predicate Device |
| Amplitude | 43.6 mT/m | 36 mT/m |
| Rise time | 0.17 ms | 0.24 ms |
| Slew rate | 257 T/m/s | 150 T/m/s |
| Patient Table | Filing Device | Predicate Device |
| Dimensions (L x W x H) | 92.1 x 24.6 x 34.0 inch
(2340 x 624 x 864 mm) | 96.5 x 27.6 x 36.7 inch
(2450 x 700 x 932 mm) |
| Patient positioning | Laser Localizer assisted automatic
patient table positioning.
Manual Position mode | Laser Localizer Available |
| Max Patient Weight | 200kg | 250 kg |
| Patient-control room
communication | Microphones and speaker for
two-way communication between
patient and radiologist | Magnacoustic Communication &
Music System |
| Workstation | Filing Device | Predicate Device |
| Model | Multi-Processing, Multi-Core PC
with 24-inch monitor | Quad-Core Intel Xeon with 24-inch
monitor |
| Memory and Capacity | 64GB of RAM, 250GB SSD Storage | 32GB of RAM, 2 x 400 GB SSD
Storage |
| Operating System | Microsoft Windows | Linux OS |
| Receive Coils | Filing Device | Predicate Device |
| Multi-Channel Head Coil | ✓ | ✓ |
| Multi-Channel Head and
neck Coil | ✓ | ✓ |
| Multi-Channel Shoulder
Coil | ✓ | ✓ |
| Multi-Channel Spine Coil | ✓ | ✓ |
| Multi-Channel Body Coil | ✓ | ✓ |
| Multi-Channel Closed
Breast Coil | ✓ | ✓ |
| Multi-Channel Knee Coil | ✓ | ✓ |
| Multi-Channel Ankle Coil | ✓ | ✓ |
| Multi-Channel Wrist Coil | ✓ | ✓ |
| Multi-Channel
Multi-purpose Coils | ✓ | ✓ |
| Pulse Sequences | Filing Device | Predicate Device |
| T1 Spin Echo | ✓ | ✓ |
| T1, T2 Fast Spin Echo,
HASTE | ✓ | ✓ |
| T1, T2* Gradient Echo | ✓ | ✓ |
| FLAIR | ✓ | ✓ |
| TOF Angiography | ✓ | ✓ |
| Inversion Recovery | ✓ | ✓ |
| Fat-Water Separation | ✓ | ✓ |
| Chemical Fat Sat | ✓ | ✓ |
| MRCP | ✓ | ✓ |
| DWI EPI | ✓ | ✓ |
| CMGE | ✓ | ✓ |
| SWI | ✓ | ✓ |
| 2D Image Processing
Features | Filing Device | Predicate Device |
| Image panning, zooming,
windowing | ✓ | ✓ |
| Image flipping, inverting
and rotation | ✓ | ✓ |
| Statistical Analysis | ✓ | ✓ |
| Geometric Measurement | ✓ | ✓ |
| Phase Image | ✓ | ✓ |
| CINE | ✓ | ✓ |
| Shutter | ✓ | ✓ |
| Image Filtering | ✓ | ✓ |
| Image Subtraction | ✓ | ✓ |
| Slice Profile | ✓ | ✓ |
| Histogram | ✓ | ✓ |
| 3D Image Processing
(MPR/Max.IP) | Filing Device | Predicate Device |
| Image panning, zooming,
windowing | ✓ | ✓ |
| Cutting Operation Output
Stack | ✓ | ✓ |
| Image export | ✓ | ✓ |
| The filing device basically utilizes same technologies as predicate device, and can give consistent
results when using the images in medical diagnosis. The minor differences in technological
characteristics do not constitute any safety and effectiveness issue, as indicated in performance data
provided. | | |
#### Comparison of Technological Characteristics with the Predicate Device:
{5}------------------------------------------------
{6}------------------------------------------------
{7}------------------------------------------------
| Technological
Characteristic | EMMA 1.5T MRI system is based on the principle that certain atomic nuclei
present in the human body, when placed in a strong magnetic field and
excited by a radio frequency signal at the precession frequency, will emit a
relaxation signal. The emitted relaxation signals are acquired by signal
receiving coils and are analyzed by the system. Human-interpretable
images are reconstructed by and stored in the computer and displayed on
the screen. |
|---------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | The principle components of EMMA 1.5T MRI system includes |
| | Superconducting magnet with corresponding cooling devices Gradient system RF transmission and receive system Cooling system for different components of the system Patient table and support components Spectrometer Server/Client PC and application software |
| | The superconducting magnet is made of coils of superconducting wires
and is cooled to and maintained at cryogenic temperature by an enclosed
dedicated cooling system. When energized, current flows continuously
inside the superconducting wires as a closed loop; thus producing a
constant magnetic field. This has the same major technological
characteristics as the predicate device. |
| | The gradient system consists of a gradient coil and the gradient amplifier.
The gradient coil produces varying linear gradient fields in the three
orthogonal spatial axes with currents given by the gradient amplifier. The
gradient coil can also produce various non-linear gradients fields to
improve the homogeneity of the main magnetic field. This has the same
major technological characteristics as the predicate device. |
| | The RF transmission and receive system consists of the RF amplifier, the
RF transmission coil and various RF receiver coils for receiving the
relaxation signals emitted from the subject after RF transmission. They are
coils made of copper wires tuned to transmit and receive around the
designed frequency corresponding to the magnetic field strength. This has
the same major technological characteristics as the predicate device. |
| | The cooling system maintains suitable operating temperatures for
amplifiers and other system devices. This has the same major
technological characteristics as the predicate device. |
| | The patient table and support components provide a comfortable platform
for the patient and allows the operator to easily position the patient to the
location for imaging. This has the same major technological characteristics
as the predicate device. |
| | The spectrometer controls the execution of the pulse sequence for RF
transmit and receive and gradient output. This has the same major
technological characteristics as the predicate device. |
| | The server/client PC and the application software provides the operator a
platform to configure scans and manage scanned data. Raw data received
from the spectrometer is also reconstructed here. This has the same major
technological characteristics as the predicate device. |
| | technological characteristics as the predicate device. |
| | Therefore, the same scientific technology theory is applied to both the
EMMA 1.5T MRI system and predicate device. |
| | Any minor differences in physical attributes do not constitute any safety and
effectiveness issue, as indicated in performance data provided. |
{8}------------------------------------------------
{9}------------------------------------------------
| Nonclinical Testing
Summary: | Like the predicate device, the following performance data were provided in
support of the substantial equivalence determination. |
|---------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Biocompatibility testing
The biocompatibility evaluation for the filing device was conducted in
accordance with ISO 10993-1 "Biological Evaluation of Medical Devices –
Part 1: Evaluation and Testing Within a Risk Management Process" as
recognized by FDA. |
| | Electrical safety and electromagnetic compatibility (EMC)
Electrical safety and EMC testing were conducted in accordance with AAMI
/ ANSI ES60601-1:2005/(R)2012 And A1:2012 "Medical Electrical
Equipment - Part 1: General Requirements For Basic Safety And Essential
Performance", IEC 60601-2-33:2010+A1:2013 "Medical Electrical
Equipment - Part 2-33: Particular Requirements For The Basic Safety And
Essential Performance Of Magnetic Resonance Equipment For Medical
Diagnostic for safety" and IEC 60601-1-2:2014 Edition 4 "Medical Electrical
Equipment - Part 1-2: General Requirements For Basic Safety And
Essential Performance - Collateral Standard: Electromagnetic
Disturbances - Requirements And Tests" for EMC as recognized by FDA |
| | Surface Heating of RF Receive Coils
Surface heating was tested with both coil-plugged and coil-unplugged
configurations according to AAMI/ANSI ES60601-1. The measured
temperature of the surface of the coil never exceeds the maximum limit of
41°C in either configuration. |
| | Software Verification and Validation Testing
Software verification and validation testing were conducted and
documentation was provided as recommended by FDA's Guidance for
Industry and FDA Staff, "Guidance for the Content of Premarket
Submissions for Software Contained in Medical Devices." |
| | Acoustic testing
Acoustic testing were conducted in accordance with NEMA MS 4-2010
"Acoustic Noise Measurement Procedure for Diagnosing Magnetic
Resonance Imaging Devices" |
| | Performance testing - Bench
The filing device complies with the following NEMA MS standard as does the
predicate device:
• NEMA MS-1-2008 (R2014) - Determination of Signal-to-Noise Ratio
(SNR) in Diagnostic Magnetic Resonance Images
• NEMA MS 2-2008 (R2014) - Determination of Two-Dimensional
Geometric Distortion in Diagnostic Magnetic Resonance Images
• NEMA MS 3-2008 (R2014) - Determination of Image Uniformity in
Diagnostic Magnetic Resonance Images
• NEMA MS 5-2010 - Determination of Slice Thickness in Diagnostic
Magnetic Resonance Imaging
• NEMA MS 6-2008 (R2014) - Determination of Signal-to-Noise Ratio
and Image Uniformity for Single-Channel Non-Volume Coils in
Diagnostic MR Imaging
• NEMA MS 8-2016 - Characterization Of The Specific Absorption
Rate For Magnetic Resonance Imaging Systems
The performance testing results demonstrate the safety and performance
as expected. Therefore, the filing device is substantially equivalent to the
legally marketed predicate device. |
{10}------------------------------------------------
| Clinical Testing
Summary: | Sample clinical images are provided to verify the claim of filing device's
capability in generating images for diagnostic purposes. Sample clinical
image sets from filing device and predicate device on same pulse
sequences are provided to demonstrate the substantial equivalence of filing
device to legally marketed predicate device. |
|-------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Conclusions Drawn
from Non-Clinical
Information and
Clinical Images: | The non-clinical information (safety and performance tests), combined with
clinical images (both from filing device and predicate device), demonstrate
that the filing device is as safe, as effective, and performs as well as the
predicate device. |
| SE Conclusion: | | The filing device has the same intended use as the predicate device. The
minor differences in indication for use do not constitute any safety and
effectiveness issue, as indicated in performance data provided. |
|----------------|--|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | The filing device utilizes same technologies as predicate device, and gives
consistent results (images) in medical diagnosis. Any minor differences in
physical attributes do not constitute any safety and effectiveness issue, as
indicated in performance data [non clinical/clinical] provided. |
| | | Therefore the filing device is demonstrated, for being substantially
equivalent to the legally marketed predicate device. |
---
**Source:** [https://fda.innolitics.com/device/K183621](https://fda.innolitics.com/device/K183621)
**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).
**Cite:** Innolitics at https://innolitics.com