(231 days)
Not Found
No
The document describes standard CT reconstruction algorithms (filter back-projection, iterative denoising, metal artifact correction) and does not mention AI or ML.
No
The device is described as an imaging system used to produce cross-sectional images for diagnostic purposes, not for treating diseases or conditions.
Yes
The device is a computed tomography x-ray system, and its intended use is to produce "cross-sectional images of the body by computer reconstruction of x-ray transmission data... and indicated for the whole body," which are used by post-processing applications for medical diagnosis. The device's output (images) is used to observe and evaluate abnormal conditions. Therefore, it is a diagnostic device.
No
The device description explicitly lists multiple hardware components including the Gantry, X-ray System, Data Management System, Patient Table, Console, Power Supply Cabinet, Image Processing Computer, and Vital Signal Module. While it includes software, it is an integral part of a larger hardware system.
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 "computed tomography x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles". This describes an imaging device that works by transmitting X-rays through the body and reconstructing images from the data.
- Device Description: The description details the physical components of a CT scanner (Gantry, X-ray System, Patient Table, etc.) and how it operates using X-rays.
- Lack of IVD Characteristics: An IVD device is typically used to examine specimens (like blood, urine, or tissue) outside of the body to provide information about a person's health. This device does not interact with or analyze biological specimens.
The device is a medical imaging device used for diagnostic purposes, but it falls under the category of in vivo imaging, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
uCT 760/780 is a computed tomography x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and indicated for the whole body (including head, neck, cardiac and vascular).
Product codes
JAK
Device Description
The uCT 760/780 is a multi-slice X-ray computed tomography scanner which features a continuously rotating tube-detector system and functions according to the fan beam principle. The system provides the filter back-projection (FBP) algorithm to reconstruct images in DICOM format. which can be used by post-processing applications.
The system consists of the Gantry, X-ray System, Data Management System, Patient Table, Console, Power Supply Cabinet, Image Processing Computer, Vital Signal Module and Software. The system software is a program used for patient management, data management, X-ray scan control, image reconstruction, and image archive.
A motorized patient table moves the patient through a circular opening in the Gantry. As the patient passes through the Gantry, a source of x rays rotates around the inside of the circular opening. Detectors on the exit side of the patient record the X rays exiting the section of the patient's body being irradiated as an X-ray "snapshot". Many different "snapshots" (angles) are collected during one complete rotation. The data are sent to a computer to reconstruct all of the individual "snapshots" into a crosssectional image (slice) of the internal organs and tissues for each complete rotation of the source of x rays.
There are two features for denoising and reduce metal artifact, which are KARL iterative denoising reconstruction algorithm and MAC Metal artifact correction algorithm.
This proposed device includes two models: uCT 760, uCT 780.The differences between the two models are as follows:
| Spec. Model | HV Power | Rotation speed | Minimum slice thickness | Maximum slices generated per rotation |
|---|---|---|---|---|
| uCT 760 | 80kW | Up to 0.35 sec per 360° rotation | 0.625mm | 128 |
| uCT 780 | 100kW | Up to 0.3 sec per 360° rotation | 0.5mm | 160 |
Mentions image processing
The system consists of the Gantry, X-ray System, Data Management System, Patient Table, Console, Power Supply Cabinet, Image Processing Computer, Vital Signal Module and Software. The system software is a program used for patient management, data management, X-ray scan control, image reconstruction, and image archive.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Computed Tomography X-ray
Anatomical Site
whole body (including head, neck, cardiac and vascular)
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)
Non-Clinical Testing: Non-clinical testing including dosimetry and image performance tests were conducted for the uCT 760/780 during the product development.
Performance Verification: Clinical Evaluation for sample clinical images evaluation; Artifact Evaluation Report for MAC performance study; Iterative Denoising Test Report for KARL performance study; AEC Test Report for AEC performance study.
Clinical Testing: No Clinical Study is included in this submission.
Summary: The features described in this premarket submission are supported with the results of the testing mentioned above, the uCT 760/780 was found to have a safety and effectiveness profile that is similar to the predicate device.
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
§ 892.1750 Computed tomography x-ray system.
(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue.
Shanghai United Imaging Healthcare Co., Ltd. Shumei Wang Qm&ra VP No. 2258 Chengbei Rd., Jiading Industrial District Shanghai, 201807 Cn
March 12, 2018
Re: K172135
Trade/Device Name: uCT 760, uCT 780 Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: Class II Product Code: JAK Dated: July 3, 2017 Received: July 14, 2017
Dear Shumei Wang:
This letter corrects our substantially equivalent letter of March 2, 2018.
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good
1
manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) K172135
Device Name uCT 760, uCT 780
Indications for Use (Describe)
uCT 760/780 is a computed tomography x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and indicated for the whole body (including head, neck, cardiac and vascular).
| 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 word "UNITED" stacked on top of the word "IMAGING" in a bold, sans-serif font. To the right of the text is a stylized symbol that resembles the letter "U" with a horizontal line through the top portion. The color scheme is a muted teal or gray-blue.
SECTION 2
510(k) Summary
SECTION 2 - 1 of 12
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Image /page/4/Picture/1 description: The image contains the logo for United Imaging. The logo consists of the word "UNITED" stacked on top of the word "IMAGING", both in a bold, sans-serif font. To the right of the text is a stylized "U" symbol, which is formed by two vertical lines and a horizontal line in the middle, creating a shape that resembles a "U" with a crossbar. The color of the text and the "U" symbol appears to be a dark gray or blue-gray.
510 (k) SUMMARY
- Date of Preparation 1. January 19, 2018
2. Sponsor Identification
Shanghai United Imaging Healthcare Co.,Ltd. No.2258 Chengbei Rd. Jiading District, 201807, Shanghai, China
Contact Person: Shumei Wang Position: QM&RA VP Tel: +86-021-67076888-6776 Fax: +86-021-67076889 Email: shumei.wang@united-imaging.com
3. Identification of Proposed Device
Trade Name: uCT 760, uCT 780 Common Name: Computed Tomography X-ray System Model(s): uCT 760. uCT 780
Regulatory Information Regulation Number: 21 CFR 892.1750 Regulation Name: Computed Tomography X-ray System Regulatory Class: II Product Code: JAK Review Panel: Radiology
Identification of Predicate Device(s) 4.
Predicate Device
510(k) Number: K033326 Device Name: "Philips Plus" CT scanner Model(s): Brilliance 40, Brilliance 64
Regulatory Information Regulation Number: 21 CFR 892.1750 Regulation Name: Computed Tomography X-ray System Regulatory Class: II Product Code: JAK Review Panel: Radiology
SECTION 2 - 2 of 12
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Image /page/5/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, also in a bold font. The logo is simple and modern in design.
5. Device Description:
The uCT 760/780 is a multi-slice X-ray computed tomography scanner which features a continuously rotating tube-detector system and functions according to the fan beam principle. The system provides the filter back-projection (FBP) algorithm to reconstruct images in DICOM format. which can be used by post-processing applications.
The system consists of the Gantry, X-ray System, Data Management System, Patient Table, Console, Power Supply Cabinet, Image Processing Computer, Vital Signal Module and Software. The system software is a program used for patient management, data management, X-ray scan control, image reconstruction, and image archive.
A motorized patient table moves the patient through a circular opening in the Gantry. As the patient passes through the Gantry, a source of x rays rotates around the inside of the circular opening. Detectors on the exit side of the patient record the X rays exiting the section of the patient's body being irradiated as an X-ray "snapshot". Many different "snapshots" (angles) are collected during one complete rotation. The data are sent to a computer to reconstruct all of the individual "snapshots" into a crosssectional image (slice) of the internal organs and tissues for each complete rotation of the source of x rays.
There are two features for denoising and reduce metal artifact, which are KARL iterative denoising reconstruction algorithm and MAC Metal artifact correction algorithm.
This proposed device includes two models: uCT 760, uCT 780.The differences between the two models are as follows:
| Spec.
Model | HV Power | Rotation speed | Minimum
slice thickness | Maximum slices
generated per rotation |
|----------------|----------|-------------------------------------|----------------------------|------------------------------------------|
| uCT 760 | 80kW | Up to 0.35 sec per
360° rotation | 0.625mm | 128 |
| uCT 780 | 100kW | Up to 0.3 sec per
360° rotation | 0.5mm | 160 |
6. Indications for Use
uCT 760/780 is a computed tomography X-ray system intended to produce crosssectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes and indicated for the whole body (including head, neck, cardiac and vascular).
- Comparison of Technological Characteristics with the Predicate Devices 7.
SECTION 2 - 3 of 12
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Image /page/6/Picture/1 description: The image contains the logo for United Imaging. The text "UNITED IMAGING" is displayed in bold, sans-serif font. To the right of the text is a stylized "U" shape, which is dark teal in color and has a white vertical line running through the center.
The uCT 760/780 Computed Tomography X-ray system has the same indications for use as the predicate device "Philips Plus" CT scanner. The fundamental scientific technology of the proposed device is same as the predicate device.
Table 1 below provides a comparison of the technological characteristics of the proposed device in comparison to the predicate device.
| ITEM | Proposed Device
uCT 760, uCT 780 | Predicate Device
Brilliance 40, Brilliance 64 | Remark | |
|--------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------|---------------|
| General | | | | |
| Product Code | JAK | JAK | Same | |
| Regulation No. | 21 CFR 892.1750 | 21 CFR 892.1750 | Same | |
| Class | II | II | Same | |
| Intended Use | The uCT Computed
Tomography X-ray System is a
computed tomography x-ray
system intended to produce
cross-sectional images of the
body by computer
reconstruction of x-ray
transmission data taken at
different angles and planes and
indicated for the whole body
(including head, neck, cardiac
and vascular). | The "Philips Plus" is a Whole
Body Computed Tomography
X-Ray System intended to
produce cross-sectional
images of the body by
computer reconstruction of x-
ray transmission data taken at
different angles and planes. | Same | |
| Specifications | | | | |
| Scan Regime | Continuous Rotation | Continuous Rotation | Same | |
| Scan Modes | Scout
Axial Scan
Helical Scan | Surview
Axial Scan
Helical Scan | Same | |
| Detector
Material | Solid-state GOS | Solid-state GOS | Same | |
| Z-plane
coverage | 40mm | 40mm | Same | |
| Size of detector
element in Z-
plane | 0.5mm | 0.625mm | Note
No.1 | |
| Number of
element per row | 936 | 672 | Note
No.2 | |
| Number of
detector row | 80 | 40 for Brilliance 40
64 for Brilliance 64 | Note
No.3 | |
| Maximum slices
generated per | 128 for uCT 760
160 for uCT 780 | 40 for Brilliance 40
64 for Brilliance 64 | Note
No.4 | |
| rotation (multi-slice capability) | | | | |
| Minimum slice thickness | 0.625mm for uCT 760
0.5mm for uCT 780 | 0.625mm | Same | |
| Maximum sampling rate | Up to 4800 views per 360° | Up to 4640 views per 360° | Note No.5 | |
| Tube anode storage capacity | 7.5MHU | 8.0MHU | Note No.6 | |
| Maximum cooling rate | 1386 kHU/min | 1608kHU/min | Note No.7 | |
| Focal spot size | 0.7x0.7mm
1.0x1.0mm | 0.5x1.0mm
1.0x1.0mm | Note No.8 | |
| Power | 80kW for uCT 760
100 kW for uCT 780 | 60 kW | Note No.9 | |
| mA Range | 6-667mA for uCT 760
6-833mA for uCT 780 | 30-500mA for Brilliance 40
20-500mA for Brilliance 64 | Note No.10 | |
| kV Settings | 70, 80, 100, 120, 140 | 80, 120, 140 | Note No.11 | |
| Aperture | 700mm | 700mm | Same | |
| Rotation speed | Up to 0.35 sec per 360° rotation for uCT 760
Up to 0.3 sec per 360° rotation for uCT 780 | Up to 0.42 sec per 360° rotation for Brilliance 40
Up to 0.4 sec per 360° rotation for Brilliance 64 | Note No.12 | |
| Temporal resolution | As low as 35ms | As low as 42ms | Note No.13 | |
| Gantry Tilt | ± 30°with 0.5 increment | ± 30°with 0.5 increment | Same | |
| Scannable range | 1700 mm | 1750mm | Note No.14 | |
| Horizontal motion range | 2180 mm | 1900mm | Note No.15 | |
| Table Horizontal Speed | Up to 200mm/sec | Up to 143mm/sec | Note No.16 | |
| Vertical motion range | 480 mm-950 mm from the floor | 578-1028mm | Note No.17 | |
| Vertical speed | Up to 40 mm/sec | Up to 50mm/sec | Note No.18 | |
| Table Horizontal Position accuracy | ±0.25mm | ±0.25mm | Same | |
| Table Maximum table load | 205kg | 204kg | Note No.19 | |
| Image Spatial Resolution | High mode:
20 lp/cm @ MTF 0% | High mode:
16.0lp/cm 0% | Note No.20 | |
| | | | | |
| | 16.5 lp/cm @ MTF10%
11.5 lp/cm @ MTF50% | 12.0 lp/cm @ MTF10%
6.0 lp/cm @ MTF50% | | |
| Image Noise | 3.0 HU at 120 kV, 5 mm slice thickness, CTDIvol 29.1mGy | 4.0 HU at 120 kV, 5 mm slice thickness, CTDIvol 27.3mGy | Note
No.21 | |
| CT Number
Display Range | -1024 +8191 HU | -1024 1.5 | Note+3072 HU | Note2.0 | 0.13
No.22 | |
| Scan Field of
View | Up to 500 mm
600mm with extend FOV | Up to 500 mm | Same | |
| Reconstruction
Field of View | 40mm-500mm
40mm-600mm with extend FOV | 50mm-500mm
25mm-250mm (Ultra High mode) | Note
No.23 | |
| Maximum
scannable length | 1700mm | 1750mm | Note
No.24 | |
| Image Matrix | Up to 1024 x 1024 | Up to 1024 x 1024 | Same | |
| Reconstructed
slice thickness | uCT 760:
0.625mm,1.25mm,2.5mm,5mm,10mm (axial)
0.625-10mm(helical)
uCT 780:
0.5mm,0.625mm,1.25mm,2.5mm,5mm,10mm (axial)
0.5-10mm(helical) | Spiral mode:0.67 -7.5mm
Axial mode:0.5-12mm | Note
No.25 | |
| | Pitch | 0.1
No.26 |
| | Maximum
continuous
exposure time | Up to 100seconds | Up to 100seconds | Same |
| | Slip ring | 6.25 Gbps transfer rate | Up to 5.3 Gbps transfer rate | Note
No.27 |
| | RAM | 24GB for console PC
32GB for Recon PC | 2.0GB
4.0GB (optional ) | Note
No.28 |
| | Display | 24inch, 1200 x 1920 | 19inch, 1024 x 1280 | Note
No.29 |
| | Safety | | | |
| Electrical Safety | Comply with ES60601-1 | Comply with IEC60601-1 | Same | |
| EMC | Comply with IEC60601-1-2 | Comply with IEC60601-1-2 | Same | |
| Biocompatibility | Patient Contact Materials were
tested and demonstrated no
cytotoxicity (ISO 10993-5), no
evidence for irritation and
sensitization (ISO 10993-10). | Comply with ISO10993-5,
ISO10993-10 | Same | |
| | Clinical | Sample clinical image for both proposed and predicate devices are
provided in Section 15 Clinical Evaluation. Electronic file for each image
are provide in MISC Folder. | | |
Table 1 Comparison of Technological Characteristics
SECTION 2 - 4 of 12
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Image /page/7/Picture/1 description: The image shows the logo for United Imaging. The text "UNITED IMAGING" is in bold, dark blue letters. To the right of the text is a stylized, dark blue icon that resembles the letter "U" with a horizontal line through the top portion.
SECTION 2 - 5 of 12
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Image /page/8/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, geometric symbol that resembles a capital "U" with a horizontal line across the top, creating a shape that also looks like a stylized "H". The color of both the text and the symbol is a dark teal or gray.
SECTION 2 - 6 of 12
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Image /page/9/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 formed by two vertical lines and a horizontal line connecting them at the top. The logo is simple and modern, and the use of bold fonts and geometric shapes gives it a strong and recognizable presence.
| Note ID | Justification | |
|---|---|---|
| Note 1 | Provides the smaller minimum detector element size that induces higher | |
| z-plane spatial resolution for CT imaging, which does not affect safety | ||
| and effectiveness. | ||
| Note 2 | Provides the larger detector element number per row that induces more | |
| data sampling and higher spatial resolution per row for CT imaging, | ||
| which does not affect safety and effectiveness. | ||
| Note 3 | The move to 80 slices is the addition of physical detectors increasing the | |
| total number of slices to 80, which does not affect safety and | ||
| effectiveness. | ||
| Note 4 | With a reconstruction process and reduction in (“windmill”) artifacts, 128 | |
| slices or 160 slices can be achieved from the 80 detectors. Neither of | ||
| these changes affects safety and effectiveness. | ||
| Note 5 | Provides the larger maximum sampling rate based on the full view (360°) | |
| that induces more data sampling and higher spatial resolution for CT | ||
| imaging, which does not affect safety and effectiveness. | ||
| Note 6 | Tube anode storage capacity is a kind of measurement about the | |
| maximum throughput of CT scanner. When an independent scan is | ||
| implemented, the tube is heated and if the time interval between two | ||
| independent scans is long enough, the heat can be dissipated timely but | ||
| for short scan time interval, the heat which has not been dissipated timely | ||
| should be stored within tube device and thus for the continuous scans (for | ||
| short scan time intervals), higher storage capacity means that more | ||
| continuous scan numbers can be supported. However, tube anode storage | ||
| capacity has no effect on each independent scan. | ||
| Note 7 | Similarly with Note 7, maximum cooling rate is a kind of measurement | |
| about the maximum throughput of CT scanner. For the continuous scans, | ||
| higher maximum cooling rate means that the tube heat can be dissipated | ||
| faster and thus shorter scan time interval and more continuous scan | ||
| numbers can be supported. However, it has no effect on each independent | ||
| scan. | ||
| Note 8 | Focus spot size has effect on image spatial resolution and smaller size is | |
| helpful for resolution improvement. However, the image spatial resolution | ||
| between the two kinds of devices is equivalent substantially. | ||
| Note 9 | Provide the larger power output that induces higher ability of x-ray | |
| penetration when scanning the object with high BMI with lower | ||
| possibility of photon starvation, and the safety has been evaluated by the | ||
| related testing and verification. | ||
| Note 10 | Provide the larger mA output that induces higher ability of x-ray | |
| penetration when scanning the object with high BMI with lower | ||
| possibility of photon starvation, and the safety has been evaluated by the | ||
| related testing and verification. | ||
| of photon starvation, and the safety has been evaluated by the related | ||
| testing and verification. | ||
| Note 11 | Provide small kV output such as 70kV that induces lower ability of x-ray | |
| penetration when scanning the object with low BMI with lower possibility | ||
| of photon starvation, and the safety has been evaluated by the related | ||
| testing and verification. | ||
| Provide 100KV output that induces more feasible ability of x-ray penetration when scanning the object with various BMIs, and the safety | ||
| has been evaluated by the related testing and verification. | ||
| Note 12 | Provides the shorter minimum scan time that induces better temporal | |
| resolution in advanced clinical applications, including cardiac imaging, | ||
| which does not affect safety and effectiveness. | ||
| Note 13 | Provides the shorter temporal resolution that reduces motion artifacts of | |
| cardiac imaging and increase the image quality, which does not affect | ||
| safety and effectiveness. | ||
| Note 14 | Scannable range between the two kinds of devices is equivalent | |
| substantially because both of them can cover all kinds of the height range | ||
| of current humans and they offer helical scanner mode to scan the whole | ||
| body from various human instead. | ||
| Note 15 | Provide the larger horizontal motion range that induces larger scan range, | |
| which does not affect safety and effectiveness. | ||
| Note 16 | Provide the larger table horizontal speed that induces shorter scan time | |
| with the other given scan conditions such as scan range and parameters, | ||
| which does not affect safety and effectiveness. | ||
| Note 17 | Vertical motion range is decided by device gantry and couch design | |
| which does not affect safety and effectiveness. | ||
| Note 18 | Vertical speed between the two kinds of devices is equivalent | |
| substantially and 10mm/sec difference does not affect safety and | ||
| effectiveness. | ||
| Note 19 | The maximum table load between the two kinds of devices is equivalent | |
| substantially because both of them can cover all kinds of the load range of | ||
| current humans. | ||
| Note 20 | Providing the higher image spatial resolution is helpful to distinguish the | |
| smaller structure, which does not affect safety and effectiveness. | ||
| Note 21 | With 120 kV and 5mm slice thickness, the image noise for typical head is | |
| 3HU on CTDIvol 29.1mGy, which is better than 4HU on CTDIvol | ||
| 27.3mGy. But the image noise level is equivalent substantially | ||
| considering the proposed device has measured its noise based on the | ||
| larger CTDIvol than the Predicate Device. | ||
| Note 22 | Provides the large HU range that induces more choice for various clinical | |
| scan situation and show more information in clinical images, which does | ||
| not affect safety and effectiveness. | ||
| Note 23 | Reconstruction Field of View between the two kinds of devices is | |
| equivalent substantially and the difference from lower limits does not | ||
| affect safety and effectiveness. | ||
| Note 24 | Maximum scannable length between the two kinds of devices is equivalent substantially because both of them can cover all kinds of the load range of current humans. | |
| Note 25 | Provides the more slice thickness that induce more choice for various clinical scan situations and thinner slice thickness should bring higher spatial resolution in z-plane, which does not affect safety and effectiveness. | |
| Note 26 | Provides the large pitch range that induces more choice for various clinical scan situations, which does not affect safety and effectiveness. | |
| Note 27 | ||
| Note 28 | ||
| Note 29 |
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Image /page/10/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.
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Image /page/11/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 gray. The logo is simple and modern.
The proposed device and the predicate device are the same in regard to most of application features.
Table 2 below provides a comparison of the application features of the proposed device in comparison to the predicate device.
| ITEM | Proposed Device
uCT 760, uCT 780 | Predicate Device
Brilliance 40, Brilliance 64 | Remark |
|---------------------------|-------------------------------------|--------------------------------------------------|--------------------------|
| Application Features | | | |
| Iterative noise reduction | KARL 3D | iDOSE | Functional
Equivalent |
| | Adaptive Filter | Adaptive Filter | Functional
Equivalent |
| Metal artifact reduction | MAC | MAR | Functional
Equivalent |
Table 2 Comparison of Application Features
Performance Data 8.
The following performance data were provided in support of the substantial equivalence determination.
Non-Clinical Testing
Non-clinical testing including dosimetry and image performance tests were conducted for the uCT 760/780 during the product development.
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Image /page/12/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, also in a bold font. The color of the logo is a dark teal.
UNITED IMAGING HEALTHCARE claims conformance to the following standards and guidance:
Electrical Safety and Electromagnetic Compatibility (EMC)
Electrical Safety and Electromagnetic Compatibility (EMC) testing were conducted on the uCT 760/780 in accordance with the following standards:
- A ES 60601-1:2005(R)2012+A1:2012+C1:2009/(R)2012+A2:2010/(R)2012 Medical electrical equipment Part 1: General requirements for basic safety and essential performance
- A IEC 60601-2-44 Edition 3.0 2009, Medical Electrical Equipment - Part 2-44: Particular Requirements For The Basic Safety And Essential Performance Of Xray Equipment For Computed Tomography
- A IEC 60601-1-2 Edition 3: 2007-03, Medical Electrical Equipment - Part 1-2: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Compatibility - Requirements And Tests
-
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)]
Product Particular Standards
- NEMA XR 25-2010, Computed Tomography Dose Check A
- A NEMA XR 28-2013, Supplemental Requirements For User Information And System Function Related To Dose In CT
-
NEMA XR 29-2013, Standard Attributes on CT Equipment Related to Dose Optimization and Management
-
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
- A IEC 61223-3-5 First Edition 2004-08, Evaluation And Routine Testing In Medical Imaging Departments - Part 3-5: Acceptance Tests - Imaging Performance Of Computed Tomography X-ray Equipment [Including: Technical Corrigendum 1 (2006)]
Performance Verification
- A Clinical Evaluation for sample clinical images evaluation;
- A Artifact Evaluation Report for MAC performance study;
- A Iterative Denoising Test Report for KARL performance study;
-
AEC Test Report for AEC performance study.
Software
- A NEMA PS 3.1-3.20(2011): Digital Imaging and Communications in Medicine (DICOM)
- A IEC 62304: Medical Device Software - software life cycle process
-
Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices
-
Content of Premarket Submissions for Management of Cybersecurity in
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Medical Devices
Biocompatibility
- A ISO 10993-5 Third Edition 2009-06-01, Biological Evaluation Of Medical Devices - Part 5: Tests For In Vitro Cytotoxicity
-
ISO 10993-10 Third Edition 2010-08-01, Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization
Other Standards and Guidances
- ISO 14971: Medical Devices Application of risk management to medical A devices
-
Code of Federal Regulations, Title 21. Part 820 - Quality System Regulation
- A Code of Federal Regulations, Title 21, Subchapter J - Radiological Health
-
Laser Products - Conformance with IEC 60825-1 and IEC 60601-2-22; Guidance for Industry and FDA Staff (Laser Notice No. 50)
-
Provision for Alternate Measure of the Computed Tomography Dose Index (CTDI) to Assure Compliance with the Dose Information Requirements of the Federal Performance Standard for Computed Tomography
Software Verification and Validation
Software documentation for a Moderate Level of Concern software per FDA' Guidance Document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" is included as a part of this submission.
The risk analysis was completed and risk control was implemented to mitigate identified hazards. The testing results show that all the software specifications have met the acceptance criteria. Verification and validation testing of the proposed device was found acceptable to support the claim of substantial equivalence.
UNITED IMAGING HEALTHCARE conforms to the Cybersecurity requirements by implementing a process of preventing unauthorized access, modification, misuse or denial of use, or unauthorized use of information that is stored, accessed, or transferred from a medical device to an external recipient. Cybersecurity information in accordance with guidance document "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices" is included in this submission.
Clinical Testing
No Clinical Study is included in this submission.
Summarv
The features described in this premarket submission are supported with the results of the testing mentioned above, the uCT 760/780 was found to have a safety and effectiveness profile that is similar to the predicate device.
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9. Conclusions
Based on the comparison and analysis above, the proposed device has same intended use, similar performance, equivalence safety and effeteness 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.