(193 days)
Not Found
Yes
The device description explicitly mentions "uAI Vision" as a new feature.
No.
The device is primarily a diagnostic imaging system, designed to produce cross-sectional images for medical diagnosis, including for lung cancer screening and guiding interventional procedures. While it assists in procedures like biopsy, it does not directly treat or cure a disease.
Yes
The device, uCT 760/780, is described as a "computed tomography x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data" and "is intended to be used for low dose CT lung cancer screening for the early detection of lung nodules that may represent cancer." Its function to produce images for the "early detection of lung nodules that may represent cancer" directly indicates its use in diagnosing health conditions. Furthermore, the "CT-Guided Intervention" feature assists in procedures like biopsy, which are diagnostic in nature.
No
The device description clearly states that the submission includes two models of a Computed Tomography X-ray system (uCT 760 and uCT 780), which are hardware devices. While the submission also includes a software package (uWS-CT-Dual Energy Analysis) and new software features, the core device being described and modified is a hardware CT scanner.
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 intended for use in vitro for the examination of specimens, including blood and tissue samples, derived from the human body, solely or principally for the purpose of providing information concerning a physiological or pathological state, or concerning a congenital abnormality, or to determine the safety and compatibility with potential recipients, or to monitor therapeutic measures.
- Device Function: The uCT 760/780 system is a computed tomography x-ray system. Its primary function is to produce cross-sectional images of the body using X-ray transmission data. It does this by scanning the patient directly, not by examining specimens derived from the patient.
- Intended Use: The intended use clearly states it's for producing images of the body for diagnostic purposes (e.g., detecting lung nodules, visualizing anatomical structures). While the images provide information about the patient's physiological state, this information is derived from direct imaging of the body, not from in vitro examination of specimens.
- Dual Energy Analysis: The uWS-CT-Dual Energy Analysis software is a post-processing tool for the CT images. It analyzes the image data to provide additional information about tissue composition, but it still operates on the images generated by the in vivo CT scan, not on in vitro specimens.
- CT-Guided Intervention: This feature assists in minimally invasive procedures by providing real-time imaging guidance during procedures like biopsies or drainage. This is an in vivo application, not an in vitro diagnostic test.
In summary, the uCT 760/780 system and its associated software are imaging devices that operate on the patient's body directly to produce diagnostic images. They do not involve the examination of specimens outside the body, which is the defining characteristic of an IVD.
No
The provided text does not contain explicit language stating that the FDA has reviewed and approved or cleared a Predetermined Change Control Plan (PCCP) for this specific device.
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).
uCT 760/780 is intended to be used for low dose CT lung cancer screening for the early detection of lung nodules that may represent cancer. The screening must be performed within the established inclusion criteria of programs / protocols that have been approved and published by either a governmental body or professional medical society. * Please refer to clinical literature, including the results of the National Lung Screening Trial (N Engl J Med 2011; 365:395-409) and subsequent literature, for further information.
uWS-CT-Dual Energy Analysis is a post-processing software package that accepts UIH CT images acquired using different tube voltages and/or tube currents of the same anatomical location. The various materials of an anatomical region of interest have different attenuation coefficients, which depend on the used energy. These differences provide information on the chemical composition of the scanned body materials and enable images to be generated at multiple energies within the available spectrum. uWS-CT-Dual Energy Analysis software combines images acquired with low and high energy spectra to visualize this information.
Product codes (comma separated list FDA assigned to the subject device)
JAK
Device Description
The uCT Computed Tomography X-ray system is intended to produce crosssectional images of the patient by computer reconstruction of X-ray transmission data taken at different angles and planes. These images may be obtained either with or without contrast.
This proposed device includes two models: uCT 760 and 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 |
The uWS-CT-Dual Energy Analysis is a post-processing software package that accepts UIH CT images acquired using different tube voltages and/or tube currents of the same anatomical location. The various materials of an anatomical region of interest have different attenuation coefficients, which depend on the used energy. These differences provide information on the chemical composition of the scanned body materials. CT dual energy analysis application combines images acquired with low and high energy spectra to visualize this information.
The modification performed on the uCT 760 & 780 in this submission is mainly due to the following new features:
- Low Dose CT Lung Cancer Screening Protocol
- uAI Vision
- Auto ALARA kVp
- Organ-Based Auto ALARA mA
- CT-Guided Intervention
- Injector Linkage
- Dual Energy Analysis
CT-Guided Intervention is a medical tool for assisting a minimally invasive procedure. CT-Guided Intervention in uCT 760/780 is to provide CT-imaging guidance for interventional procedures. During the CT-Guided Intervention procedure, CT images can help the user guide the needle entry path before operating a minimally invasive procedure and display the placement of the needle during a minimally invasive procedure based on the four scan modes: Single Axial, Continuous, Fluoro and Single helical. In this case, cells or tissue can be taken for biopsy, or minimally invasive surgeries such as drainage and ablation can be performed.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Yes
Input Imaging Modality
Computed Tomography (CT)
Anatomical Site
Whole body (including head, neck, cardiac and vascular), lung, kidney, joint
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 and uCT 780 to verify that the proposed device met all design specifications as it is Substantially Equivalent (SE) to the predicate device.
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
§ 892.1750 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.
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August 1, 2023
Shanghai United Imaging Healthcare Co., Ltd. % Xin Gao Regulatory Affairs Manager No. 2258 Chengbei Rd., Jiading Industrial District SHANGHAI 201807 CHINA
Re: K230162
Trade/Device Name: uCT 760 with uWS-CT-Dual Energy Analysis, uCT 780 with uWS-CT-Dual Energy Analysis Regulation Number: 21 CFR 892.1750 Regulation Name: Computed Tomography X-Ray System Regulatory Class: Class II Product Code: JAK Dated: July 7, 2023 Received: July 10, 2023
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
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
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,
Lu Jiang
Lu Jiang, Ph.D. Assistant Director Diagnostic X-Ray Systems Team DHT8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health Page 2
Enclosure
2
Indications for Use
510(k) Number (if known) K230162
Device Name
uCT 760 with uWS-CT-Dual Energy Analysis, uCT 780 with uWS-CT-Dual Energy Analysis
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).
uCT 760/780 is intended to be used for low dose CT lung cancer screening for the early detection of lung nodules that may represent cancer. The screening must be performed within the established inclusion criteria of programs / protocols that have been approved and published by either a governmental body or professional medical society. * Please refer to clinical literature, including the results of the National Lung Screening Trial (N Engl J Med 2011; 365:395-409) and subsequent literature, for further information.
uWS-CT-Dual Energy Analysis is a post-processing software package that accepts UIH CT images acquired using different tube voltages and/or tube currents of the same anatomical location. The various materials of an anatomical region of interest have different attenuation coefficients, which depend on the used energy. These differences provide information on the chemical composition of the scanned body materials and enable images to be generated at multiple energies within the available spectrum. uWS-CT-Dual Energy Analysis software combines images acquired with low and high energy spectra to visualize this information.
Type of Use ( Select one or both, as applicable ) | ||
---|---|---|
X Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) | X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
X 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 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, with a horizontal line running through the middle of the U. The logo is a dark gray color.
510 (K) SUMMARY K230162
-
- Date of Preparation July 31, 2023
2. Sponsor Identification
Shanghai United Imaging Healthcare Co.,Ltd. No.2258 Chengbei Rd. Jiading District, 201807, Shanghai, China
Contact Person: Xin GAO Position: Regulatory Affair Manager Tel: +86-021-67076888-5386 Fax: +86-021-67076889 Email: xin.gao@united-imaging.com
Identification of Proposed Device 3.
| Trade Name | uCT 760 with uWS-CT-Dual
Energy Analysis | uCT 780 with uWS-CT-Dual
Energy Analysis |
|-------------|---------------------------------------------|---------------------------------------------|
| 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.
Primary Predicate Device
510(k) Number: K172135 Device Name: uCT 760, uCT 780 Regulation Name: Computed Tomography X-ray System
4
Image /page/4/Picture/1 description: The image contains the logo for United Imaging. The logo consists of the words "UNITED IMAGING" stacked on top of each other in a bold, sans-serif font. To the right of the text is a stylized "U" symbol, 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.
Regulatory Class: II Product Code: JAK Review Panel: Radiology
Secondary Predicate Device 1
510(k) Number: K203448 Device Name: uCT ATLAS with uWS-CT-Dual Energy Analysis Regulation Name: Computed Tomography X-ray System Regulatory Class: II Product Code: JAK Review Panel: Radiology
Secondary Predicate Device 2
510(k) Number: K211373
Device Name: SOMATOM go.Now, SOMATOM go.Up, SOMATOM go.All, SOMATOM go.Top, SOMATOM go.Sim, SOMATOM go.Open Pro, SOMATOM X.cite SOMATOM X.ceed, Scan&GO Software Regulation Name: Computed Tomography X-ray System Regulatory Class: II Product Code: JAK Review Panel: Radiology
5. Device Description:
The uCT Computed Tomography X-ray system is intended to produce crosssectional images of the patient by computer reconstruction of X-ray transmission data taken at different angles and planes. These images may be obtained either with or without contrast.
This proposed device includes two models: uCT 760 and 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 |
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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 a bold, sans-serif font, stacked on top of each other. To the right of the text is a stylized "U" symbol, which is dark gray and has a white horizontal line through the middle. The overall design is clean and modern.
The uWS-CT-Dual Energy Analysis is a post-processing software package that accepts UIH CT images acquired using different tube voltages and/or tube currents of the same anatomical location. The various materials of an anatomical region of interest have different attenuation coefficients, which depend on the used energy. These differences provide information on the chemical composition of the scanned body materials. CT dual energy analysis application combines images acquired with low and high energy spectra to visualize this information.
The modification performed on the uCT 760 & 780 in this submission is mainly due to the following new features:
- Low Dose CT Lung Cancer Screening Protocol .
- . uAI Vision
- . Auto ALARA kVp
- Organ-Based Auto ALARA mA
- CT-Guided Intervention
- Injector Linkage
- . Dual Energy Analysis
CT-Guided Intervention is a medical tool for assisting a minimally invasive procedure. CT-Guided Intervention in uCT 760/780 is to provide CT-imaging guidance for interventional procedures. During the CT-Guided Intervention procedure, CT images can help the user guide the needle entry path before operating a minimally invasive procedure and display the placement of the needle during a minimally invasive procedure based on the four scan modes: Single Axial, Continuous, Fluoro and Single helical. In this case, cells or tissue can be taken for biopsy, or minimally invasive surgeries such as drainage and ablation can be performed.
Comparison details are shown in Section 7.
Indications for Use 6.
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).
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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" stacked on top of each other in a bold, sans-serif font. To the right of the text is a stylized symbol that resembles a shield or a rounded square with a vertical line running down the center and a horizontal line across the top, forming a "T" shape within the shield.
uCT 760/780 is intended to be used for low dose CT lung cancer screening for the early detection of lung nodules that may represent cancer. The screening must be performed within the established inclusion criteria of programs / protocols that have been approved and published by either a governmental body or professional medical society.
- Please refer to clinical literature, including the results of the National Lung Screening Trial (N Engl J Med 2011; 365:395-409) and subsequent literature, for further information.
uWS-CT-Dual Energy Analysis is a post-processing software package that accepts UIH CT images acquired using different tube voltages and/or tube currents of the same anatomical location. The various materials of an anatomical region of interest have different attenuation coefficients, which depend on the used energy. These differences provide information on the chemical composition of the scanned body materials and enable images to be generated at multiple energies within the available spectrum. uWS-CT-Dual Energy Analysis software combines images acquired with low and high energy spectra to visualize this information.
- Comparison of Technological Characteristics with the Predicate Device 7. The indications for use for the proposed device is same as that for the primary predicate device (K172135), except for the addition of the dual-energy functionality and the low dose CT lung cancer screening, which are same as in the indications for use for the secondary predicate device 1 (K203448).
A comparison between the technological characteristics of proposed and predicate devices is provided as below.
7
| ITEM | Proposed Device | Predicate Device
uCT 760, uCT 780
(K172135) | Secondary Predicate Device 1
uCT ATLAS with uWS-CT-
Dual Energy Analysis
(K203448) | Secondary Predicate Device 2
SOMATOM go.Now, SOMATOM go.Up,
SOMATOM go.All, SOMATOM go.Top,
SOMATOM go.Sim, SOMATOM go.Open
Pro, SOMATOM X.cite SOMATOM
X.ceed, Scan&GO Software (K211373) | Discussion
of
Differences |
|---------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------|
| Specifications | | | | | |
| Gantry | Rotation speed: up to
0.35s/rotation for uCT
760; 0.3s/rotation for
uCT 780
70cm bore | Rotation speed up to
0.35s/rotation for uCT
760; 0.3s/rotation for
uCT 780
70cm bore | -- | -- | Same |
| Detector | 40mm Detector
Material: Solid-state
GOS
80 rows,
936 channels/row
Size of detector
element in Z-plane:
0.5mm | 40mm Detector
Material: Solid-state
GOS
80 rows,
936 channels/row
Size of detector
element in Z-plane:
0.5mm | -- | -- | Same |
| X-ray Tube | 70, 80, 100, 120, 140
kV
mA range: 10mA-
667mA for uCT 760;10
mA-667mA, 10mA-
833mA(option) for
uCT 780
Anode heat capacity:
7.5MHU | 70, 80, 100, 120, 140
kV
mA range: 10mA-
667mA for uCT 760;10
mA-667mA, 10mA-
833mA(option) for
uCT 780
Anode heat capacity:
7.5MHU | -- | -- | Same |
| | Maximum anode heat
dissipation:
1386kHU/min
Focal spot size:
$0.7mm \times 0.7mm$
$1.0mm \times 1.0mm$ | Maximum anode heat
dissipation:
1386kHU/min
Focal spot size:
$0.7mm \times 0.7mm$
$1.0mm \times 1.0mm$ | | | |
| High Voltage Generator | 80kW for uCT 760;
80kW, 100kW(option)
for uCT 780
70, 80, 100, 120, 140
kV | 80kW for uCT 760;
80kW, 100kW(option)
for uCT 780
70, 80, 100, 120, 140
kV | -- | -- | Same |
| Patient Table | Max load capacity
205kg(Standard
Configuration);
318kg(High
Configuration) | Max load capacity
205kg | -- | -- | Note 1 |
| Maximum Slices | 128 for uCT 760 | 128 for uCT 760 | -- | -- | Same |
| Generated per Rotation | 160 for uCT 780 | 160 for uCT 780 | | | |
| Reconstruction Field of
View | 40-500mm
40-600mm with
extended FOV | 40-500mm
40-600mm with
extended FOV | -- | -- | Same |
| Functions | | | | | |
| KARL 3D | Yes | Yes | -- | -- | Same |
| Metal Artifact
Correction (MAC) | Yes | Yes | -- | -- | Same |
| Reconstruction
Field of View | 40mm-500mm
40mm-600mm with
extend FOV | 40mm-500mm
40mm-600mm with
extend FOV | -- | -- | Same |
| Auto ALARA mA | Yes | Yes | -- | -- | Same |
| CardioXphase | Yes | -- | Yes | -- | Same |
| | | | | | |
| Deep Recon (DELTA) | Yes | Yes | -- | -- | Same |
| Low Dose CT Lung
Cancer Screening
Protocol | Yes | -- | Yes | -- | Same |
| uAI Vision-
EasyPositioning-
EasyISO | Yes | -- | Yes | -- | Same |
| Auto ALARA kVp | Yes | -- | Yes | -- | Same |
| Organ-Based Auto
ALARA mA | Yes | -- | Yes | -- | Same |
| EasyRange | Yes | -- | Yes | -- | Same |
| Injector Linkage | Yes | -- | Yes | -- | Same |
| Remote Assistance | Yes | -- | Yes | -- | Same |
| Shuttle Perfusion | Yes | -- | Yes | -- | Same |
| Real Time 3D | Yes | -- | Yes | -- | Same |
| Online MPR | Yes | -- | Yes | -- | Same |
| CT-guided Intervention | | | | | |
| CT-guided Intervention | Yes | -- | -- | Yes | Functional
Equivalent |
| Hardware (added due to the CT-Guided Intervention) | | | | | |
| Scanning Room
Monitor | Yes | -- | -- | Yes | Functional
Equivalent |
| Exposure Foot Pedal | Yes | -- | -- | Yes | Functional
Equivalent |
| Hand Cart | Yes | -- | -- | Yes | Functional
Equivalent |
| Suspension Gear | Yes | -- | -- | Yes | Functional
Equivalent |
| Couch Side Controller | Yes | -- | -- | Yes | Functional
Equivalent |
| Scan mode (added due to the CT-Guided Intervention) | | | | | |
| Single Axial Mode | Yes | -- | -- | i-Sequence Functional Equivalent | |
| Single Helical Mode | Yes | -- | -- | i-Spiral Functional Equivalent | |
| Fluoro Mode | Yes | -- | -- | i-Fluoro Functional Equivalent | |
| Continuous Mode | Yes | -- | -- | -- Note 2 | |
| 2D & 3D Path Planning | Yes | -- | -- | Yes Functional Equivalent | |
| 3D Image Guidance | Yes | -- | -- | Yes Functional Equivalent | |
| Dual Energy | | | | | |
| Dual Energy Scan | Yes | -- | Yes | -- Same | |
| Dual Energy Analysis | | | | | |
| Mono Energetic Image | Yes | -- | Yes | -- Same | |
| Mixed Enhanced Image | Yes | -- | Yes | -- Same | |
| CNR(Contrast Noise Ratio) Image | Yes | -- | Yes | -- Same | |
| Water-Iodine Base Material Pair | Yes | -- | Yes | -- Same | |
| Water-Calcium Base Material Pair | Yes | -- | Yes | -- Same | |
| Calcium-Iodine Base Material Pair | Yes | -- | Yes | -- Same | |
| Uric acid-Calcium Base Material Pair | Yes | -- | Yes | -- Same | |
| Image Registration | Yes | -- | Yes | -- Same | |
| Effective Atomic Number Images | Yes | -- | Yes | -- Same | |
| Component analysis of kidney stones, uric acid stones or non-uric acid stones
Component analysis of joint gout, uric acid gout or non-uric acid gout | | | | | |
| Electron Density Image | Yes | -- | Yes | -- | Same |
| Virtual Non Contrast Images | Yes | -- | Yes | -- | Same |
d the Ca Table 1 Ca . na to Dradicato Davias anderri Dradio
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Image /page/8/Picture/1 description: The image contains the logo for United Imaging. The text "UNITED IMAGING" is in bold, sans-serif font. To the right of the text is a stylized icon that appears to be a square with a line through the middle, creating a U-like shape. The logo is simple and modern in design.
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Image /page/9/Picture/1 description: The image contains the logo for United Imaging. The text "UNITED IMAGING" is written in bold, sans-serif font. To the right of the text is a stylized "U" symbol, which is also in a bold font. The logo is simple and modern in design.
10
Image /page/10/Picture/1 description: The image contains the logo for United Imaging. The words "UNITED IMAGING" are stacked on top of each other and are in a bold, sans-serif font. To the right of the text is a stylized "U" symbol. The symbol is made up of two vertical lines and one horizontal line, creating a shape that resembles a "U" with a line through the middle.
11
Image /page/11/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 "U" symbol, which is also in a bold font. The logo is simple and modern in design.
*: The new features that the proposed device compared to predicate device have been highlight in the table.
Note 1: The proposed device is configured with two types of patient table. One is same as the predicate is with higher load capacty than the predicate device. The two tables being a major componed device are conforms to the safety standards such as IEC 60601-1 series and applicable to the performance standards in 21 CFR subchapter J and satisfy with the clinical applications. The difference will not raise new safety and effectiveness concerns.
Note 2: The proposed device adds a scan mode during the inference will not raise new safety and effectiveness concerns.
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Performance Data 8.
● Non-Clinical Testing
Non-clinical testing including dosimetry and image performance tests were conducted for the uCT 760 and uCT 780 to verify that the proposed device met all design specifications as it is Substantially Equivalent (SE) to the predicate device.
UNITED IMAGING HEALTHCARE claims conformance to the following standards and guidance:
● Electrical Safety and Electromagnetic Compatibility (EMC)
- A ANSI AAMI ES60601-1:2005+A1:2012+A2:2021, Medical electric for basic safety and essential performance (IEC 60601-1:2005, MOD) [Including Amendment 2 (2021)].
- A IEC 60601-1-2: 2014, Edition 4.0, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests.
- A IEC 60601-1-3: 2008+AMD1:2013+A2:2021, Edition 2.2, 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 60601-2-44 Edition 3.2: 2016 Medical electrical equipment - Part 2-44: Particular requirements for the basic safety and essential performance of x-ray equipment for computed tomography
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IEC 60825-1: 2014, Edition 3.0, Safety of laser products - Part 1: Equipment classification and requirements.
- A IEC 60601-1-6: 2010+A1:2013+A2:2020, Edition 3.2, Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability.
- A NEMA XR 25-2019, Computed Tomography Dose Check
- A NEMA XR 28-2018, Supplemental Requirements For User Information And System Function Related To Dose In CT
- A NEMA XR 29-2013, Standard Attributes on CT Equipment Related to Dose Optimization and Management
- A IEC 61223-3-5:2004+COR1:2006, Evaluation and routine testing in medical imaging departments - Part 3-5: Acceptance tests - Imaging performance of computed tomography X-ray equipment
- Software
- A NEMA PS 3.1-3.20(2016): Digital Imaging and Communications in Medicine
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Image /page/13/Picture/1 description: The image contains the logo for United Imaging. The logo consists of the words "UNITED IMAGING" stacked on top of each other in a bold, sans-serif font. To the right of the text is a stylized "U" shape, which is also in a bold font. The color of the text and the "U" shape is a dark gray.
(DICOM)
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Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices
- A Content of Premarket Submissions for Management of Cybersecurity in Medical Devices
● Biocompatibility
- ISO 10993-5: 2009, Edition 3.0, Biological evaluation of medical devices Part A 5: Tests for in vitro cytotoxicity.
- A ISO 10993-10: 2010, Edition 3.0, Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization.
● Other Standards and Guidances
- ISO 14971: 2019, Edition 3.0, Medical Devices Application of risk A management to medical devices
- A Code of Federal Regulations, Title 21, Part 820 - Quality System Regulation
- A Code of Federal Regulations, Title 21, Subchapter J - Radiological Health
- A 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
Summarv
The features described in this premarket submission are supported with the results of the testing mentioned above, the uCT 760 and uCT 780 were found to have a safety and effectiveness profile that is similar to the predicate device.
Conclusions 9.
Based on the comparison and analysis above, the proposed device has same intended use, similar performance, safety equivalence, and effectiveness as the predicate devices. The differences above between the proposed device and predicate devices 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 devices.