(401 days)
No
The document does not mention AI, ML, or any related terms, nor does it describe any features or performance metrics typically associated with AI/ML in medical imaging (e.g., training/test sets, AUC, sensitivity/specificity for AI-driven tasks). The focus is on standard C-arm functionality and image processing.
No
The device is described as an X-ray system intended for digital imaging of patients during diagnostic and surgical procedures to assist clinical decisions by visualizing anatomical structures. This indicates a diagnostic rather than a therapeutic function.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the device is intended for "diagnostic and surgical procedures" and that "The visualization of such anatomical structures assists the clinical decisions." The "Summary of Performance Studies" also mentions that images were reviewed and found to be of "diagnostic quality."
No
The device description explicitly lists multiple hardware components, including a C-arm, Monoblock, detector, collimator, handswitch, footswitch, cables, monitor cart, control panel, and workstation. This indicates it is a physical medical device system, not software-only.
Based on the provided information, 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.
- Device Function: The uMC 560i is an X-ray system used to create digital images of anatomical structures within the patient's body during diagnostic and surgical procedures. It does not analyze samples taken from the patient.
- Intended Use: The intended use clearly states it provides "digital imaging of patients" and "visualization of such anatomical structures." This is consistent with an imaging device, not an IVD.
- Device Description: The description details the components of an X-ray system (C-arm, Monoblock, detector, etc.), which are used for generating and capturing X-ray images.
- Input Modality: The input modality is X-ray, which is an imaging technique, not a method for analyzing biological samples.
Therefore, the uMC 560i falls under the category of a medical imaging device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The uMC 560i is intended to provide digital imaging of patients during diagnostic and surgical procedures. Examples of clinical application may include, but are not limited to: orthopedic, pain therapy, neurological, pediatric examinations and critical care. The visualization of such anatomical structures assists the clinical decisions. This device does not support direct radiographic film exposures and is not intended for use in performing mammography.
Product codes
OWB, OXO, JAA
Device Description
uMC 560i is the first mobile C-arm X-ray system developed and produced by UIH Medical XR Business Unit. It is designed to meet medical institutions' demands. To cover the most surgical imaging needs, it's X-ray imaging of the anatomical structures of patient during clinical applications may include, but are not limited to: orthopedic, pain therapy, neurological, pediatric examinations and critical care. uMC 560i consists of C-arm, Monoblock, Anti-scatter Grid, CMOS flat panel detector, Collimator system, Exposure handswitch, Exposure footswitch, Connects cables for Monitor cart and C-arm mobiles stand. Monitor cart, Touchable control panel, HD monitor, Examination workstation. The powerful system performance brings a safe, fluent and efficient operation experience.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
Not Found
Indicated Patient Age Range
adults and pediatric
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)
Non clinical tests were conducted to verify that the proposed device met all design specifications as it is Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
- A ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 (Consolidated Text) Medical electric for basic safety and essential performance (IEC 60601-1:2005, MOD).
- IEC 60601-1-3 Edition 2.1 2013-04 Medical electrical equipment - Part 1-3: General requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment.
- IEC 60601-1-6 Edition 3.1 2013-10 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability.
- IEC 60601-2-28 Edition 2.0 2010-03 Medical electrical equipment -Part 2-28: Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis.
- IEC 60601-2-43 Edition 2.1 2017-05 CONSOLIDATED VERSION Medical electrical equipment - Part 2-43: Particular requirements for the safety and essential performance of X-ray equipment for interventional procedures.
- A IEC 60601-2-54 CONSOLIDATED VERSION Edition 1.1 2015-04 Medical electrical equipment - Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy.
- IEC 62304 Edition 1.1 2015-06 Medical device software - Software life cvcle processes.
- A IEC 60601-1-2 Edition 4.0 2014-02 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests.
Clinical Test Conclusion:
The fluoroscopy sequences images and static images produced by the uMC 560i in clinical environment accompanied by exposure mode, exposure parameters and anatomical regions were provided in the clinical evaluation. Both dynamic and static images were reviewed by a board-certified clinical reviewer with a statement indicating that images are of diagnostic quality.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1650 Image-intensified fluoroscopic x-ray system.
(a)
Identification. An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left side of the logo is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 19, 2019
Shanghai United Imaging Healthcare Co., Ltd. % Shumei Wang OM & RA VP No. 2258 Chengbei Rd., Jiading Industrial District Shanghai, Shanghai 201807 CHINA
Re: K183144
Trade/Device Name: uMC 560i Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: Class II Product Code: OWB, OXO, JAA Dated: November 27, 2018 Received: November 29, 2018
Dear Shumei Wang:
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 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/combination-products/guidance-regulatory-information/postmarketing-safety-reporting
1
combination-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 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-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,
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K183144
Device Name uMC 560i
Indications for Use (Describe)
The uMC 560i is intended to provide digital imaging of patients during diagnostic and surgical procedures. Examples of clinical application may include, but are not limited to: orthopedic, pain therapy, neurological, pediatric examinations and critical care. The visualization of such anatomical structures assists the clinical decisions. This device does not support direct radiographic film exposures and is not intended for use in performing mammography.
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/3/Picture/1 description: The image contains 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, which is also in a bold font. The color of the logo is a dark teal.
510 (k) SUMMARY
-
- Date of Preparation: November 26, 2019
2. Sponsor Identification
Shanghai United Imaging Healthcare Co.,Ltd.
No.2258 Chengbei Rd. Jiading District, 201807, Shanghai, China Establishment Registration Number: 3011015597 Contact Person: Xin GAO Tel: +86-021-67076888-5386 Fax: +86-021-67076889 Email: xin.gao@united-imaging.com
3. Identification of Proposed Device
Trade Name: uMC 560i Common Name: Mobile C-arm X-Ray System Model(s): uMC 560i Regulatory Information Classification Name: Image-intensified fluoroscopic x-ray system Classification: Product Code: OWB, OXO, JAA Regulation Number: 21 CFR 892.1650 Review Panel: Radiology
-
- Identification of Predicate Device(s)
Predicate Device 510(k) Number: K153244 Device Name: Cios Fusion Manufacturer: Siemens AG Regulatory Information Classification Name: Image-intensified fluoroscopic x-ray system Classification: II Product Code: OWB, OXO Regulation Number: 21 CFR 892.1650 Review Panel: Radiology Reference Device
- Identification of Predicate Device(s)
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Image /page/4/Picture/1 description: The image shows 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, which is also in a bold, sans-serif font. The logo is simple and modern, and the use of bold fonts gives it a strong and confident look.
510(k) Number: K181560 Device Name: Cios Alpha Manufacturer: Siemens AG
Regulatory Information
Classification Name: Image-intensified fluoroscopic x-ray system Classification: II Product Code: OWB. OXO Regulation Number: 21 CFR 892. 1650 Review Panel: Radiology
5. Device Description
uMC 560i is the first mobile C-arm X-ray system developed and produced by UIH Medical XR Business Unit. It is designed to meet medical institutions' demands. To cover the most surgical imaging needs, it's X-ray imaging of the anatomical structures of patient during clinical applications may include, but are not limited to: orthopedic, pain therapy, neurological, pediatric examinations and critical care. uMC 560i consists of C-arm, Monoblock, Anti-scatter Grid, CMOS flat panel detector, Collimator system, Exposure handswitch, Exposure footswitch, Connects cables for Monitor cart and C-arm mobiles stand. Monitor cart, Touchable control panel, HD monitor, Examination workstation. The powerful system performance brings a safe, fluent and efficient operation experience.
6. Indications for Use
The uMC 560i is intended to provide digital imaging of patients during diagnostic and surgical procedures. Examples of clinical application may include, but are not limited to: orthopedic, pain therapy, neurological, pediatric examinations and critical care. The visualization of such anatomical structures assists the clinician with clinical decisions. This device does not support direct radiographic film exposures and is not intended for use in performing mammography.
7. Performance Data
Non-Clinical Test Conclusion
Non clinical tests were conducted to verify that the proposed device met all design specifications as it is Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
- A ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 (Consolidated Text) Medical electric for basic safety and essential performance (IEC 60601-1:2005, MOD).
-
IEC 60601-1-3 Edition 2.1 2013-04 Medical electrical equipment - Part 1-3: General requirements for basic safety and essential performance - Collateral
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Image /page/5/Picture/1 description: The image shows the logo for United Imaging. The words "UNITED IMAGING" are in bold, sans-serif font, stacked on top of each other. To the right of the words is a stylized letter "U" that is split in the middle by a vertical line. The logo is simple and modern.
Standard: Radiation protection in diagnostic X-ray equipment.
-
IEC 60601-1-6 Edition 3.1 2013-10 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability.
-
IEC 60601-2-28 Edition 2.0 2010-03 Medical electrical equipment -Part 2-28: Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis.
-
IEC 60601-2-43 Edition 2.1 2017-05 CONSOLIDATED VERSION Medical electrical equipment - Part 2-43: Particular requirements for the safety and essential performance of X-ray equipment for interventional procedures.
- A IEC 60601-2-54 CONSOLIDATED VERSION Edition 1.1 2015-04 Medical electrical equipment - Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy.
-
IEC 62304 Edition 1.1 2015-06 Medical device software - Software life cvcle processes.
- A IEC 60601-1-2 Edition 4.0 2014-02 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests.
Clinical Test Conclusion
The fluoroscopy sequences images and static images produced by the uMC 560i in clinical environment accompanied by exposure mode, exposure parameters and anatomical regions were provided in the clinical evaluation. Both dynamic and static images were reviewed by a board-certified clinical reviewer with a statement indicating that images are of diagnostic quality.
8. Substantially Equivalent (SE) Comparison
| Table 1 Comparison of Device Functionality and Specification | |||
|---|---|---|---|
| ITEM | Proposed Device | ||
| uMC 560i | Predicate Device | ||
| Siemens Cios Fusion | |||
| (K153244) | Remark | ||
| General | |||
| Mobile | |||
| Fluoroscopic | |||
| C-arm | Yes | Yes | Same |
| Product Code | OWB, OXO | OWB, OXO | Same |
| Class | II | II | Same |
| Indications for | |||
| Use | The uMC 560i is intended to | ||
| provide digital imaging of | |||
| patients during diagnostic and | |||
| surgical procedures. | |||
| Examples of clinical | |||
| application may include, but | The Cios Fusion is a mobile X- | ||
| Ray System designed to | |||
| provide X-ray imaging of the | |||
| anatomical structures of patient | |||
| during clinical applications. | |||
| Clinical applications may | Note 1 | ||
| are not limited to: orthopedic, pain therapy, neurological, pediatric examinations and critical care. The visualization of such anatomical structures assists the clinician with clinical decisions. This device does not support direct radiographic film exposures and is not intended for use in performing mammography. | include but are not limited to: interventional fluoroscopic, gastrointestinal, endoscopic, urologic, pain management, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures. The patient population may include pediatric patients. | ||
| Specifications | |||
| Imaging Modes | Pulsed Fluoroscopy Spot Fluoroscopy Digital Radiography | Pulsed Fluoroscopy Continuous Fluoroscopy Digital Radiography | Note 2 |
| X-ray Tube | Stationary Anode | Stationary Anode | Same |
| X-ray Generator and Tube Housing Assembly Monoblock Technology | Yes | Yes | Same |
| KV Range | 40 kV – 110 kV | 40 kV – 110 kV | Same |
| Max Power Output | 3.5 kW | 2.3 kW | Note 3 |
| Pulsed Fluoroscopy Current | 0.1 mA – 30 mA | 3 mA - 25 mA | Note 4 |
| Displays | 34" TFT Flat Screen Color Display Panel | 19" TFT Flat Screen Color Display Panels | Note 5 |
| Collimator | Yes, Pd, Rectangular and Slot Collimator | Yes, Pd, Rectangular and Slot Collimator | Same |
| SID | 107.5 cm | 102 cm | Note 6 |
| Removable Anti-scatter Grid | Yes | Yes | Same |
| Dose Area Product | Yes | Yes | Same |
| Monitor Cart | Mandatory Monitor Cart | Mandatory Monitor Cart | Same |
| User Interface | Yes, Touch Panel | Yes, Touch Panel | Same |
| Dose Optimization | uFree Dose Management Technology | Siemens CARE Program | Note 7 |
| DICOM Function | Yes | Yes | Same |
| 2D Image Post | |||
| Processing | Yes | Yes | Same |
| Safety | |||
| Electrical | |||
| Safety | AAMI ANSI ES60601- | ||
| 1:C1:2009/(R)2012 and | |||
| A2:2010/(R)2012 | Comply with AAMI/ANSI ES | ||
| 60601-1(IEC 60601-1:2005) | Same | ||
| EMC | Comply with IEC60601-1-2 | Comply with IEC60601-1-2 | Same |
| Biocompatibili | |||
| ty | Comply with ISO10993-5, | ||
| ISO10993-10 | Comply with ISO10993-5, | ||
| ISO10993-10 | Same |
Table 1 Comparison of Device Functionality and Specification
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Image /page/7/Picture/1 description: The image contains 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" symbol, which is also in a bold, sans-serif font.
Table 2 Comparison of Flat Panel Detector Specification
| ITEM | Proposed Device | Reference Device | Remark |
|---|---|---|---|
| uMC 560i | Siemens Cios Alpha (K181560) | ||
| Specifications of Flat Panel Detector | |||
| Image Receptor | CMOS Flat Panel Detector | ||
| XINEOS 2222HS | CMOS Flat Panel Detector | ||
| XINEOS 3030HS or XINEOS 2222HS | Same | ||
| DQE | 75% | 75% (XINEOS 2222HS) | |
| 72% (XINEOS 3030HS) | Same | ||
| Dynamic Range | 96dB | 96dB | Same |
| Modulation Transfer Function (MTF) | 60% @1lp/mm | 60% @1lp/mm(XINEOS 2222HS) | |
| 58% @1lp/mm(XINEOS 3030HS) | Same | ||
| Digitization Depth | 16bit | 16bit | Same |
| Field of View | Square, 21.5 cm ×21.5 cm | Square, 20 cm ×20 cm (XINEOS 2222HS) | |
| Square, 30 cm ×30 cm (XINEOS 3030HS) | Note 8 | ||
| Pixel Size | 151.8 μm | 152 μm | Same |
| Matrix Size | 1416 × 1420 | 1416 × 1420 (XINEOS 2222HS) | |
| 1952×1952 (XINEOS 3030HS) | Same |
Table 3 Justifications of Differences
| Note ID | Justification |
|---|---|
| Note 1 | uMC 560i and the predicate devices are all used for providing digital |
| imaging of adults and pediatric during diagnostic and surgical procedures. | |
| The difference is that uMC 560i is not intended to be used during | |
| interventional, which does not affect the clinical application of uMC 560i. | |
| The difference does not affect safety and effectiveness. |
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Image /page/8/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" symbol, which is dark blue and appears to be made up of two vertical lines and a curved base.
| Note 2 | Compared to predicate devices Siemens Cios Fusion (K153244),
uMC 560i does not provide continuous fluoroscopy, whose fundamental principle and clinical application are the same with pulsed fluoroscopy. The difference does not affect safety and effectiveness. uMC 560i also provides spot fluoroscopy, whose fundamental principle is the same with pulsed fluoroscopy. The difference between spot fluoroscopy and pulsed fluoroscopy is that radiation stops automatically when meeting target grey level, but the image quality is the same with LIH of pulsed fluoroscopy. The difference does not affect safety and effectiveness. |
|--------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Note 3 | 3.5 kW has the ability to provide higher mA at lower kV levels allowing shorter pulse widths at variable frame rates to increase the image quality of moving objects by reducing or eliminating the movement during each single pulse. The difference in maximum power output does not affect safety and effectiveness. |
| Note 4 | The pulsed fluoroscopy current of predicate devices can be covered by uMC 560i's in clinical application. And the maximum current of uMC 560i is larger than predicate devices, which will improve the image quality of large patient. The difference in pulsed fluoroscopy current does not affect safety and effectiveness. |
| Note 5 | The display with larger size will improve user experience, which does not affect safety and effectiveness. |
| Note 6 | The slight difference of SID does not affect clinical application. The difference does not affect safety and effectiveness. |
| Note 7 | uMC 560i and the predicate devices all provide dose optimization method. Even though the principle is different, the effectiveness of uFree can be proven by Section 21 Software Design Description (Chapter 3.3.8). The difference does not affect safety and effectiveness. |
| Note 8 | uMC 560i and the reference device (K181560) both use the same flat panel detector. uMC 560i has a larger effective imaging area than Cios Alpha. The slight difference of Field of View does not affect clinical application. The difference does not affect safety and effectiveness. |
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Image /page/9/Picture/1 description: The image contains the logo for United Imaging. The words "UNITED IMAGING" are stacked on top of each other in bold, sans-serif font. To the right of the words is a stylized "U" shape, which is also in bold. The color of the text and the "U" shape is a dark teal.
9. Substantially Equivalent (SE) Conclusion
Based on the comparison and analysis above, the proposed device has same intended use, similar performance, equivalence safety and effectiveness 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.
The proposed device is determined to be Substantially Equivalent (SE) to the predicate device.