(133 days)
Not Found
No
The summary does not mention AI, ML, deep learning, or any related terms, and the device description focuses on standard MRI components and performance testing against established standards.
No
The device is described as a "magnetic resonance diagnostic device (MRDD)" and its purpose is to "produce images" and "display internal anatomical structure and/or function" to "assist the diagnosis," rather than directly treating a condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "indicated for use as a magnetic resonance diagnostic device (MRDD)" and that the images and parameters "may assist the diagnosis." The "Device Description" also refers to it as a "superconducting magnetic resonance diagnostic device."
No
The device description explicitly lists numerous hardware components (magnet, RF power amplifier, RF coils, gradient power amplifier, gradient coils, patient table, spectrometer, computer, equipment cabinets, power distribution system, internal communication system, and vital signal module). This indicates it is a physical medical device 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 perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. These tests are performed outside of the living body (in vitro).
- Device Description and Intended Use: The description clearly states the uMR 790 is a "magnetic resonance diagnostic device (MRDD)" that produces images of internal anatomical structures and function. This is an in vivo diagnostic method, meaning it is performed within the living body.
- Lack of Mention of Samples: The description does not mention the analysis of any biological samples.
The uMR 790 is a medical imaging device used for diagnostic purposes, but it operates by generating images of the body directly, not by testing samples taken from the body.
N/A
Intended Use / Indications for Use
The uMR 790 system is indicated for use as a magnetic resonance diagnostic device (MRDD) that produces sagittal, transverse, coronal, and oblique cross sectional images, and that display internal anatomical structure and/or function of the head, body and extremities.
These images and the physical parameters derived from the interpreted by a trained physician yield information that may assist the diagnosis. Contrast agents may be used depending on the region of interest of the scan.
Product codes (comma separated list FDA assigned to the subject device)
LNH
Device Description
The uMR 790 is a 3.0T superconducting magnetic resonance diagnostic device with a 60cm size patient bore. It consists of components such as magnet, RF power amplifier, RF coils, gradient power amplifier, gradient coils, patient table, spectrometer, computer, equipment cabinets, power distribution system, internal communication system, and vital signal module etc. The uMR 790 Magnetic Resonance Diagnostic Device is designed to conform to NEMA and DICOM standards.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance Diagnostic Device (MRDD)
Anatomical Site
head, body and extremities
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Summary of Non-Clinical Tests:
- A ES60601-1:2005/(R)2012, Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance
- A IEC 60601-1-2 Edition 3.0 2007-03, Medical Electrical Equipment - Part 1-2: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Disturbances - Requirements And Tests
- A 60601-2-33 Ed. 3.1:2013, Medical Electrical Equipment - Part 2-33: Particular Requirements For The Basic Safety And Essential Performance Of Magnetic Resonance Equipment For Medical Diagnostic
- A IEC 60825-1 Edition 2.0 2007-03, Safety Of Laser Products - Part 1: Equipment Classification, And Requirements [Including: Technical Corrigendum 1 (2008), Interpretation Sheet 1 (2007), Interpretation Sheet 2 (2007)]
- ISO 10993-5 Third Edition 2009-06-01, Biological Evaluation Of Medical A Devices - Part 5: Tests For In Vitro Cytotoxicity
- A ISO 10993-10 Third Edition 2010-08-01, Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization
- A MS 1-2008(R2014), Determination of Signal-to-Noise Ratio (SNR) in Diagnostic Magnetic Resonance Images
- A MS 2-2008(R2014), Determination of Two-Dimensional Geometric Distortion in Diagnostic Magnetic Resonance Images
- A MS 3-2008(R2014), Determination of Image Uniformity in Diagnostic Magnetic Resonance Images
- A MS 4-2010, Acoustic Noise Measurement Procedure for Diagnosing Magnetic Resonance Imaging Devices
- MS 5-2010, Determination of Slice Thickness in Diagnostic Magnetic A Resonance Imaging
- A MS 6-2008(R2014), Determination of Signal-to-Noise Ratio and Image Uniformity for Single-Channel Non-Volume Coils in Diagnostic MR Imaging
-
MS 8-2008, Characterization Of The Specific Absorption Rate For Magnetic Resonance Imaging Systems
- A MS 9-2008(R2014), Standards Publication Characterization of Phased Array Coils for Diagnostic Magnetic Resonance Images
The test results demonstrated that the device performs as expected and thus, it is substantially equivalent to the predicate devices to which it has been compared.
Summary of Clinical Tests:
- A volunteer study was used to determine the safety limits associated with A gradient-induced nerve stimulation.
- A Sample clinical images were provided to support the ability of uMR 790 to generate diagnostic quality images in accordance with the MR guidance on premarket notification submissions.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
Not Found
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).
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 logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white. To the right of the square, the words "U.S. FOOD & DRUG ADMINISTRATION" are written in blue.
Shanghai United Imaging Healthcare Co., Ltd. Xin GAO Regulatory Affairs Specialist No. 2258 Chengbei Rd., Jiading Industrial District SHANGHAI, CHINA 201807
October 3, 2018
Re: K181371
Trade/Device Name: uMR 790 Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic Resonance Diagnostic Device Regulatory Class: Class II Product Code: LNH Dated: May 21, 2018 Received: May 23, 2018
Dear Xin GAO:
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. Although this letter refers to your product as a device, please be aware 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
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 A. 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) K181371
Device Name uMR 790
Indications for Use (Describe)
The uMR 790 system is indicated for use as a magnetic resonance diagnostic device (MRDD) that produces sagittal, transverse, coronal, and oblique cross sectional images, and that display internal anatomical structure and/or function of the head, body and extremities.
These images and the physical parameters derived from the interpreted by a trained physician yield information that may assist the diagnosis. Contrast agents may be used depending on the region of interest of the scan.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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3
Image /page/3/Picture/1 description: The image contains the logo for United Imaging. The text "UNITED" is stacked on top of the text "IMAGING". To the right of the text is a stylized logo that appears to be a "U" with a horizontal line through the middle.
510 (k) SUMMARY
-
- Date Prepared [21 CFR 807.92(a)(1)] May 21, 2018
2. General Information [21 CFR 807.92(a)(1)]
| Manufacturer: | Shanghai United Imaging Healthcare Co., Ltd
2258 Chengbei Rd., Jiading District, Shanghai, 201807 |
| --------------- | ------------------------------------------------------------------------------------------------------ |
|---|
| Contact Person: | Xin GAO |
|---|---|
| Regulatory Affairs Specialist | |
| Tel: +86 (21) 67076888-5386 | |
| Fax: +86-021-67076889 | |
| Email: xin.gao@united-imaging.com |
3. Trade Name, Common Name, Classification [21 CFR 807.92(a)(2)]
| Trade Name: | uMR 790 |
|---|---|
| Common Name: | Magnetic Resonance Diagnostic Device |
| Model: | uMR 790 |
| Product Code: | LNH |
| Regulation Number: | 892.1000 |
| Device Class: | II |
4. Identification of Predicate Devices(s) [21 CFR 807.92(a)(3)]
The identification of predicates device within this submission is as follow:
Predicate Device Manufacturer: SIEMENS AG Device Name: MAGNETOM Prisma Product Code: LNH Device Class: II Regulation Number: 21 CFR 892.1000 FDA 510 (k) #: K132119
-
- Device Description [21 CFR 807.92(a)(4)]
The uMR 790 is a 3.0T superconducting magnetic resonance diagnostic device with a
- Device Description [21 CFR 807.92(a)(4)]
SECTION 7 - 2 of 4
4
Image /page/4/Picture/1 description: The image contains the logo for United Imaging. The logo consists of the words "UNITED IMAGING" in bold, sans-serif font, stacked on top of each other. To the right of the text is a stylized "U" shape, which is dark blue with a white vertical line running through the center. The overall design is clean and modern.
60cm size patient bore. It consists of components such as magnet, RF power amplifier, RF coils, gradient power amplifier, gradient coils, patient table, spectrometer, computer, equipment cabinets, power distribution system, internal communication system, and vital signal module etc. The uMR 790 Magnetic Resonance Diagnostic Device is designed to conform to NEMA and DICOM standards.
6. Intended Use [21 CFR 807.92(a)(5)]
The uMR 790 system is indicated for use as a magnetic resonance diagnostic device (MRDD) that produces sagittal, transverse, coronal, and oblique cross sectional images, and spectroscopic images, and that display internal anatomical structure and/or function of the head, body and extremities.
These images and the physical parameters derived from the images when interpreted by a trained physician yield information that may assist the diagnosis. Contrast agents may be used depending on the region of interest of the scan.
7. Technological Characteristic [21 CFR 807.92(a)(6)]
The uMR 790 has the same major technological characteristics as the predicate device. The differences from the predicate device including high order shimming configuration, interventional usage, RFPA power and external triggering function are discussed in the comparison table in this submission. The same scientific technology theory, similar physical design, same coil applications and functionalities are applied to both the uMR 790 and predicate device. The technical characteristic differences do not affect the safety and effectiveness of the uMR 790 for intended use.
8. Substantial Equivalence [21 CFR 807.92(b)(1) and 807.92(b)(2)]
Summary of Non-Clinical Tests:
The following testing was conducted on the uMR 790 Magnetic Resonance Diagnostic Device as the predicate device:
- A ES60601-1:2005/(R)2012, Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance
- A IEC 60601-1-2 Edition 3.0 2007-03, Medical Electrical Equipment - Part 1-2: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Disturbances - Requirements And Tests
- A 60601-2-33 Ed. 3.1:2013, Medical Electrical Equipment - Part 2-33: Particular Requirements For The Basic Safety And Essential Performance Of Magnetic Resonance Equipment For Medical Diagnostic
- A IEC 60825-1 Edition 2.0 2007-03, Safety Of Laser Products - Part 1: Equipment Classification, And Requirements [Including: Technical Corrigendum 1 (2008), Interpretation Sheet 1 (2007), Interpretation Sheet 2 (2007)]
SECTION 7 - 3 of 4
5
Image /page/5/Picture/1 description: The image shows the logo for United Imaging. The logo consists of the words "UNITED IMAGING" in bold, dark blue letters, stacked on top of each other. To the right of the words is a stylized "U" shape, also in dark blue, with a white vertical line running through the center of the "U".
- ISO 10993-5 Third Edition 2009-06-01, Biological Evaluation Of Medical A Devices - Part 5: Tests For In Vitro Cytotoxicity
- A ISO 10993-10 Third Edition 2010-08-01, Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization
- A MS 1-2008(R2014), Determination of Signal-to-Noise Ratio (SNR) in Diagnostic Magnetic Resonance Images
- A MS 2-2008(R2014), Determination of Two-Dimensional Geometric Distortion in Diagnostic Magnetic Resonance Images
- A MS 3-2008(R2014), Determination of Image Uniformity in Diagnostic Magnetic Resonance Images
- A MS 4-2010, Acoustic Noise Measurement Procedure for Diagnosing Magnetic Resonance Imaging Devices
- MS 5-2010, Determination of Slice Thickness in Diagnostic Magnetic A Resonance Imaging
- A MS 6-2008(R2014), Determination of Signal-to-Noise Ratio and Image Uniformity for Single-Channel Non-Volume Coils in Diagnostic MR Imaging
-
MS 8-2008, Characterization Of The Specific Absorption Rate For Magnetic Resonance Imaging Systems
- A MS 9-2008(R2014), Standards Publication Characterization of Phased Array Coils for Diagnostic Magnetic Resonance Images
The test results demonstrated that the device performs as expected and thus, it is substantially equivalent to the predicate devices to which it has been compared.
Summary of Clinical Tests:
- A volunteer study was used to determine the safety limits associated with A gradient-induced nerve stimulation.
- A Sample clinical images were provided to support the ability of uMR 790 to generate diagnostic quality images in accordance with the MR guidance on premarket notification submissions.
9. Conclusion [21 CFR 807.92(b)(3)]
In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this premarket notification, we concludes that uMR 790 Magnetic Resonance Diagnostic Device is substantially equivalent to the predicate device. It does not introduce new indications for use, and has the same technological characteristics and does not introduce new potential hazards or safety risks.