(25 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on hardware components and standard performance testing.
No
The device is described as a "magnetic resonance diagnostic device" used to produce images and spectroscopic images to assist in diagnosis, not to treat a condition.
Yes.
The "Intended Use / Indications for Use" section explicitly states "The uMR Omega system is indicated for use as a magnetic resonance diagnostic device (MRDD)". Additionally, it mentions that the images derived from the device "may assist the diagnosis" when interpreted by a trained physician.
No
The device description explicitly lists numerous hardware 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. This indicates it is a hardware-based medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a "magnetic resonance diagnostic device (MRDD)" that produces images of internal anatomical structure and/or function. It also mentions that the images and derived parameters are interpreted by a trained physician to assist in diagnosis. This describes an in vivo imaging device, not an in vitro diagnostic device.
- Device Description: The description details the components of an MRI system (magnet, coils, patient table, etc.), which are used for imaging the inside of a living body.
- Lack of IVD Characteristics: There is no mention of analyzing samples taken from the body (like blood, urine, tissue) or performing tests on those samples outside of the body, which are the hallmarks of an IVD.
Therefore, the uMR Omega system is an in vivo diagnostic imaging device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The uMR Omega system is indicated for use as a magnetic resonance diagnostic device (MRDD) that produces sagittal, transverse, coronal, and obligue 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 vield information that may assist the diagnosis. Contrast agents may be used depending on the region of interest of the scan.
Product codes
LNH, MOS
Device Description
The uMR Omega is a 3.0T superconducting magnetic resonance diagnostic device with a 75cm 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 Omega Magnetic Resonance Diagnostic Device is designed to conform to NEMA and DICOM standards.
uMR Omega has been previously cleared by FDA via K230152. The modification performed on uMR Omega (K230152) in this submission is due to the addition of Breast Coil -24.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance
Anatomical Site
head, body and extremities
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 following testing was conducted on uMR Omega and were provided in support of the substantial determination.
Item: Surface heating
Verification/Validation Method(s): Perform test according to NEMA MS 14
Acceptance Criteria: The maximum temperature of all temperature probes shall not exceed 41°C.
Summary of Results: Pass
Item: General electrical/mechanical safety
Verification/Validation Method(s): Perform test according to ANSI/AAMI ES60601-1
Acceptance Criteria: Conform with ANSI/AAMI ES60601-1
Summary of Results: Pass
Item: SNR and Uniformity
Verification/Validation Method(s): Perform test according to NEMA MS 1, NEMA MS 3, NEMA MS 6 and NEMA MS 9
Acceptance Criteria: SNR and Uniformity shall fulfill the design specification.
Summary of Results: Pass
Item: Biocompatibility
Verification/Validation Method(s): Biocompatibility evaluation in agreement with recommendations in Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process"
Acceptance Criteria: Materials of construction and manufacturing materials exempt from testing according to the Biocompatibility guidance (Attachment G), the 510(k) numbers for devices where these materials have been previously approved, or full biocompatibility report (assessment of sensitization, irritation and cytotoxicity risks) for components that have direct contact with the patient.
Summary of Results: All the materials of patient-contacting components for the Breast Coil - 24 are identical to uMR Omega which was cleared in K230152 in formulation, processing, sterilization, and geometry, and no other chemicals have been added (e.g., plasticizers, fillers, additives, cleaning agents, mold release agents).
Item: EMC-immunity, electrostatic discharge
Verification/Validation Method(s): Perform test according to IEC 60601-1-2 and IEC 60601-4-2
Acceptance Criteria: Conform with IEC 60601-1-2 and IEC 60601-4-2
Summary of Results: Pass
Item: Clinical image quality
Verification/Validation Method(s): Evaluate the image generated by Breast Coil-24 with the same method as the predicate device
Acceptance Criteria: Image quality is sufficient for diagnostic use.
Summary of Results: The U.S. Board Certified radiologist approves that image quality is sufficient for diagnostic use.
The test results demonstrated that the device performed as expected and thus, it is substantial equivalent to the predicate devices to which it has been compared.
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 logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 22, 2024
Shanghai United Imaging Healthcare Co., Ltd. % Xin Gao RA Manager No. 2258 Chengbei Rd. Jiading District Shanghai. 201807 China
Re: K240540
Trade/Device Name: uMR Omega Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: Class II Product Code: LNH, MOS Dated: February 24, 2024 Received: February 26, 2024
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 (the 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 available 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.
1
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
2
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
D. Ryker
Daniel M. Krainak, Ph.D. Assistant Director DHT8C: Division of Radiological Imaging and Radiation Therapy Devices OHT8: Office of Radiological Health Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
Submission Number (if known)
Device Name
uMR Omega
Indications for Use (Describe)
The uMR Omega system is indicated for use as a magnetic resonance diagnostic device (MRDD) that produces sagittal, transverse, coronal, and obligue 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 vield 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)
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Image /page/4/Picture/1 description: The image shows the text "K240540" at the top. Below that is the logo for United Imaging. The logo consists of the words "UNITED IMAGING" in a bold, sans-serif font, stacked on top of each other. To the right of the text is a stylized "U" shape, also in a bold font.
510 (k) SUMMARY
1. Date of Prepared
February 26, 2024
Sponsor Identification 2.
Shanghai United Imaging Healthcare Co., Ltd. No.2258 Chengbei Rd. Jiading District, 201807, Shanghai, China
Contact Person: Xin GAO Position: Regulatory Affairs Specialist Tel: +86-021-67076888-5386 Fax: +86-021-67076889 Email: xin.gao@united-imaging.com
3. Identification of Proposed Device(s)
Trade Name: uMR Omega Common Name: Magnetic Resonance Diagnostic Device Model: uMR Omega
Regulatory Information Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH, MOS Review Panel: Radiology
4. Identification of Predicate Devices(s)
Predicate Device 510(k) Number: K230152 Model: uMR Omega Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH Review Panel: Radiology
Device Description 5.
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Image /page/5/Picture/1 description: The image shows the logo for United Imaging. The words "UNITED" and "IMAGING" are stacked on top of each other in a bold, sans-serif font. To the right of the words is a stylized letter "U" that is also in a bold font. The logo is simple and modern.
The uMR Omega is a 3.0T superconducting magnetic resonance diagnostic device with a 75cm 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 Omega Magnetic Resonance Diagnostic Device is designed to conform to NEMA and DICOM standards.
uMR Omega has been previously cleared by FDA via K230152. The modification performed on uMR Omega (K230152) in this submission is due to the addition of Breast Coil -24.
The modification does not affect the intended use or alter the fundamental scientific technology of the device.
6. Indications for Use
The uMR Omega 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. Comparison of Technological Characteristics with the Predicate Device
The differences from the predicate device are discussed in the comparison table in this submission as below.
| ITEM | Proposed Device
uMR Omega | Predicate Device
uMR Omega (K230152) | Remark |
|------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|
| Indications For
Use | The uMR Omega 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 | The uMR Omega 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 | Same |
Table 1 Comparison of Modification
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Image /page/6/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, dark blue emblem that resembles a shield or a stylized letter "U" with a vertical white line running through the center.
| ITEM | Proposed Device
uMR Omega | Predicate Device
uMR Omega (K230152) | Remark |
|--------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|--------|
| may assist the diagnosis. Contrast
agents may be used depending on
the region of interest of the scan. | may assist the diagnosis. Contrast
agents may be used depending on
the region of interest of the scan. | may assist the diagnosis. Contrast
agents may be used depending on
the region of interest of the scan. | |
| Breast Coil - 24 | Yes | No | Note 1 |
The intended use of Breast coil -24 is equivalent to previously cleared Breast Coil-10. The difference Note between them is the number of channels of the receiver coil. 1 The difference did not raise new safety and effectiveness concerns.
Based on the comparison and analysis above, the proposed device has same intended use, similar performance, equivalence safety and effeteness in hardware and software as the predicate device. The differences above between the proposed device and predicate device do not affect the intended use, technology characteristics, safety and effectiveness. And no issues are raised regarding to safety and effectiveness.
Performance Data 8.
The following testing was conducted on uMR Omega and were provided in support of the substantial determination.
| Item | Verification/Validation
Method(s) | Acceptance Criteria | Summary of Results |
|--------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Surface heating | Perform test according to
NEMA MS 14 | The maximum temperature
of all temperature probes
shall not exceed 41℃. | Pass |
| General
electrical/mechanical
safety | Perform test according to
ANSI/AAMI ES60601-1 | Conform with
ANSI/AAMI ES60601-1 | Pass |
| SNR and Uniformity | Perform test according to
NEMA MS 1, NEMA MS
3, NEMA MS 6 and
NEMA MS 9 | SNR and Uniformity shall
fulfill the design
specification. | Pass |
| Biocompatibility | Biocompatibility
evaluation in agreement
with recommendations in
Use of International
Standard ISO 10993-1,
"Biological evaluation of
medical devices - Part 1:
Evaluation and testing | Materials of construction
and manufacturing
materials exempt from
testing according to the
Biocompatibility guidance
(Attachment G), the
510(k) numbers for
devices where these | All the materials of
patient-contacting
components for the Breast
Coil - 24 are identical to
uMR Omega which was
cleared in K230152 in
formulation, processing,
sterilization, and |
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Image /page/7/Picture/1 description: The image shows 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 words is a stylized "U" shape, which is also in a bold font. The color of the logo is a dark teal.
| within a risk management
process" | materials have been
previously approved, or
full biocompatibility report
(assessment of
sensitization, irritation and
cytotoxicity risks) for
components that have
direct contact with the
patient. | geometry, and no other
chemicals have been
added (e.g., plasticizers,
fillers, additives, cleaning
agents, mold release
agents). | |
|------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------|
| EMC-immunity,
electrostatic discharge | Perform test according to
IEC 60601-1-2 and IEC
60601-4-2 | Conform with IEC 60601-
1-2 and IEC 60601-4-2 | Pass |
| Clinical image quality | Evaluate the image
generated by Breast Coil-
24 with the same method
as the predicate device | Image quality is sufficient
for diagnostic use. | The U.S. Board Certified
radiologist approves that
image quality is sufficient
for diagnostic use. |
The test results demonstrated that the device performed as expected and thus, it is substantial equivalent to the predicate devices to which it has been compared.
9. Conclusion
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 conclude that the uMR Omega Magnetic Resonance Diagnostic Device is substantially equivalent to the predicate device. It does not introduce new indications for use, and performance test results support that the technical characteristic change of the Breast Coil - 24 (i.e., the number of channels in the coil) does not introduce new potential hazards or safety risks.