(140 days)
Not Found
Yes
The device description explicitly mentions "Deep IR (also named AIIR), which combines the model-based iterative reconstruction and deep learning technology together". Deep learning is a subset of machine learning.
No
The device is a diagnostic imaging system (CT scanner) used to produce images for diagnosis, not to provide therapy or treatment. Its primary function is to detect and visualize conditions, such as lung nodules, rather than to treat them.
Yes
The device is a Computed Tomography (CT) x-ray system intended to produce cross-sectional images of the whole body. It is also specifically intended for low dose CT lung cancer screening for the early detection of lung nodules that may represent cancer. These functions are inherently diagnostic as they provide information used to identify or monitor diseases or conditions. The post-processing software also aids in providing information on the chemical composition of scanned body materials, which is also for diagnostic purposes.
No
The device description explicitly states that the proposed device includes "image acquisition hardware" in addition to software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The uCT ATLAS Astound is a computed tomography x-ray system. It produces images of the inside of the body using x-rays. This is an in vivo imaging technique, meaning it is performed on a living organism.
- Intended Use: The intended use describes producing cross-sectional images of the whole body and specifically for low dose CT lung cancer screening. This involves imaging the patient directly, not analyzing samples taken from the patient.
- Device Description: The description focuses on the hardware and software for acquiring and processing x-ray images of the body.
While the device is used for diagnostic purposes (identifying potential medical conditions through imaging), it does so by directly interacting with the patient's body using x-rays, not by analyzing samples in a laboratory setting. Therefore, it falls under the category of medical imaging devices, not In Vitro Diagnostics.
No
The letter does not mention that the FDA has reviewed and approved or cleared a Predetermined Change Control Plan (PCCP) for this specific device. The input explicitly states "Control Plan Authorized (PCCP) and relevant text: Not Found".
Intended Use / Indications for Use
uCT ATLAS Astound is a computed tomography x-ray system, which is intended to produce cross-sectional images of the whole body by computer reconstruction of x-ray transmission data taken at different angles and planes. uCT ATLAS Astound is applicable to head, whole body, cardiac, and vascular x-ray Computed Tomography.
uCT ATLAS Astound 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
JAK
Device Description
The proposed device uCT ATLAS Astound with uWS-CT-Dual Energy Analysis includes image acquisition hardware, image acquisition, reconstruction and dual energy analysis software, and associated accessories.
The uCT ATLAS Astound is a multi-slice computed tomography scanner that features the following specification and technologies.
- 40 mm z-coverage in a single axial exposure with a 80-row 0.5 mm-slice Z-● Detector
- . 0.25 s rotation speed for high temporal resolution, and maximum 310 mm/s fast helical scanning capability
- 82 cm bore size, 318 kg (700 lbs) maximum table load capacity allows flexible . positioning and access for all patients
- . The new generation reconstruction method, Deep IR (also named AIIR), which combines the model-based iterative reconstruction and deep learning technology together, in order to reduce image noise and artifacts, while at the same time improving low contrast detectability and spatial resolution
- The uAI Vision patient positioning assistance
Built upon these technologies, the uCT ATLAS Astound is designed to use less radiation dose. Further, the fast scanning capability benefits the clinical applications, especially for cardiac imaging, dynamic whole organ imaging and fast body and vascular imaging.
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Yes
Input Imaging Modality
Computed Tomography X-ray
Anatomical Site
whole body, head, cardiac, and vascular, lung
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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:
Dosimetry and image performance tests were conducted for the uCT ATLAS Astound with uWS-CT Dual Energy Analysis to verify that the proposed device met all design specifications.
Clinical Image Evaluation:
The clinical image evaluation was performed under the proposed device. Sample image of head, neck, chest, abdomen, spine, hip, knee, pelvis and so on were provided with a board certified radiologist to evaluate the image quality in this submission. Each image was reviewed with a statement indicating that image quality are sufficient for clinical diagnosis.
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
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February 16, 2023
Shanghai United Imaging Healthcare Co., Ltd. % Xin Gao Regulatory Affairs Manager No. 2258 Chengbei Rd., Jiading Industrial District SHANGHAI, SHANGHAI 201807 CHINA
Re: K223028
Trade/Device Name: uCT ATLAS Astound 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: January 11, 2023 Received: January 17, 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 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,
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
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name
uCT ATLAS Astound with uWS-CT-Dual Energy Analysis
Indications for Use (Describe)
uCT ATLAS Astound is a computed tomography x-ray system, which is intended to produce cross-sectional images of the whole body by computer reconstruction of x-ray transmission data taken at different angles and planes. uCT ATLAS Astound is applicable to head, whole body, cardiac, and vascular x-ray Computed Tomography.
uCT ATLAS Astound 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) | |
|---|---|
| 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 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 bold and appears to be a dark teal color. The logo is simple and modern in design.
510 (K) SUMMARY
-
- Date of Preparation September 29, 2022
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
3. Identification of Proposed Device
Device Name: uCT ATLAS Astound with uWS-CT-Dual Energy Analysis Common Name: Computed Tomography X-ray System Model(s): uCT ATLAS Astound
Regulatory Information
Regulation Number: 21 CFR 892.1750 Regulation Name: Computed Tomography X-ray System Regulatory Class: II Product Code: JAK Review Panel: Radiology
4. Identification of Predicate/Reference Device(s)
Predicate Device
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
-
- Device Description:
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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" shape, which is also in a bold, sans-serif font. The color of the logo is a dark gray.
The proposed device uCT ATLAS Astound with uWS-CT-Dual Energy Analysis includes image acquisition hardware, image acquisition, reconstruction and dual energy analysis software, and associated accessories.
The uCT ATLAS Astound is a multi-slice computed tomography scanner that features the following specification and technologies.
- 40 mm z-coverage in a single axial exposure with a 80-row 0.5 mm-slice Z-● Detector
- . 0.25 s rotation speed for high temporal resolution, and maximum 310 mm/s fast helical scanning capability
- 82 cm bore size, 318 kg (700 lbs) maximum table load capacity allows flexible . positioning and access for all patients
- . The new generation reconstruction method, Deep IR (also named AIIR), which combines the model-based iterative reconstruction and deep learning technology together, in order to reduce image noise and artifacts, while at the same time improving low contrast detectability and spatial resolution
- The uAI Vision patient positioning assistance
Built upon these technologies, the uCT ATLAS Astound is designed to use less radiation dose. Further, the fast scanning capability benefits the clinical applications, especially for cardiac imaging, dynamic whole organ imaging and fast body and vascular imaging.
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.
6. Indications for Use
uCT ATLAS Astound is a computed tomography x-ray system, which is intended to produce cross-sectional images of the whole body by computer reconstruction of x-ray transmission data taken at different angles and planes. uCT ATLAS Astound is applicable to head, whole body, cardiac, and vascular x-ray Computed Tomography.
uCT ATLAS Astound 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.
5
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" shape, also in a bold font, with a horizontal line running through the middle of the "U". The color of the logo is a dark teal.
- 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.
7. Comparison of Technological Characteristics with the Predicate Device
The uCT ATLAS Astound with uWS-CT-Dual Energy Analysis has the same indications for use as the predicate device uCT ATLAS with uWS-CT-Dual Energy Analysis.
A comparison between the technological characteristics of proposed and predicate devices is provided as below.
| ITEM | Proposed Device | Predicate Device | Discussion |
|---|---|---|---|
| Specifications | |||
| Gantry | Rotation speed: up to | ||
| 0.25s/rotation | |||
| 82cm bore | Rotation speed: up to | ||
| 0.25s/rotation | |||
| 82cm bore | Same | ||
| Detector | 40mm Detector | ||
| Material: Solid-state GOS | |||
| 80 rows, | |||
| 936 channels/row | |||
| Size of detector element in | |||
| Z-plane: 0.5mm | 160mm Detector | ||
| Material: Solid-state GOS | |||
| 320 rows, | |||
| 936 channels/row | |||
| Size of detector element in | |||
| Z-plane: 0.5mm | Note 1 | ||
| X-ray tube | 60, 70, 80, 100, 120, 140 kV | ||
| mA range: 10mA-667mA, | |||
| 10mA-833mA(option) | 60, 70, 80, 100, 120, 140 kV | ||
| mA range: 10mA-833mA | Note 2 | ||
| ITEM | Proposed Device | Predicate Device | Discussion |
| Anode heat capacity: | |||
| 30MHU equivalently | Anode heat capacity: | ||
| 30MHU equivalently | |||
| Maximum anode heat | |||
| dissipation: | |||
| 20kW(1696kHU/min) | Maximum anode heat | ||
| dissipation: | |||
| 20kW(1696kHU/min) | |||
| Focal spot size: | |||
| 0.4mm × 0.7mm | |||
| 0.6mm × 0.7mm | |||
| 1.1mm × 1.2mm | Focal spot size: | ||
| 0.4mm × 0.8mm | |||
| 0.6mm × 0.8mm | |||
| 1.1mm × 1.2mm | |||
| High Voltage | |||
| Generator | 80kW, 100kW(option) | ||
| 60, 70, 80, 100, 120, 140 kV | 100kW | ||
| 60, 70, 80, 100, 120, 140 kV | Note 3 | ||
| Patient Table | Max load capacity | ||
| 205kg (Standard | |||
| Configuration); | |||
| 318kg (High Configuration) | Max load capacity | ||
| 318kg | Note 4 | ||
| Reconstruction | |||
| Field of View | 40-500mm | ||
| 40-600mm with extended | |||
| FOV | 40-500mm | ||
| 40-600mm with extended | |||
| FOV | Same | ||
| Maximum slices | |||
| generated per | |||
| rotation | 160 | 640 | Note 5 |
| Functions | |||
| Low Dose CT | |||
| Lung Cancer | |||
| Screening | |||
| Protocol | Yes | Yes | Same |
| uAI Vision- | |||
| EasyPositioning | |||
| EasyISO | Yes | Yes | Same |
| Easy Range | Yes | Yes | Same |
| Injector Linkage | Yes | Yes | Same |
| Remote | |||
| Assistance | Yes | Yes | Same |
| ITEM | Proposed Device | Predicate Device | Discussion |
| Auto ALARA | |||
| kVp | Yes | Yes | Same |
| Auto ALARA mA | Yes | Yes | |
| Organ-Based Auto | |||
| ALARA mA | Yes | Yes | Same |
| Deep IR (which is | |||
| also named AIIR) | Yes | Yes | |
| KARL 3D | Yes | Yes | |
| CardioXphase | Yes | Yes | Note 6 |
| CardioCapture | Yes | Yes | Note 7 |
| Metal Artifact | |||
| Correction | Yes | Yes | Same |
Table 1 Comparisons to Predicate Device
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Image /page/6/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 logo is simple and modern, and the colors are muted.
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Image /page/7/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 divided vertically by a white line, creating a visual effect of a "U" and an "I" combined. The logo is simple and modern in design.
Table 2 Dual Energy comparison to Reference Devices
| Item | Proposed device | Predicate Device | Discussion |
|---|---|---|---|
| Dual Energy Scan | |||
| Dual Energy Analysis | Yes | Yes | Same |
| 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 |
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Image /page/8/Picture/1 description: The image shows the logo for United Imaging. The text "UNITED IMAGING" is in 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 bold. The color of the text and the "U" shape is a dark teal.
Virtual Non contrast Images
Yes
Yes
Same
| Justification | |
|---|---|
| Note 1 | The detector dimension of the proposed device is shorter than that of the |
| predicate device. Detector rows of the proposed device is less than those of the | |
| predicate device. The shorter detector Z-plane coverage, the longer scanning | |
| time for CT imaging. The smaller number of rows, the less image information | |
| obtained. | |
| The difference did not raise new safety and effectiveness concerns. | |
| Note 2 | The proposed device is configured with two different ranges of mA ranges. One |
| is same with the predicate device, one is smaller than the predicate device, | |
| based on the x-ray tube hardware. Smaller mA output that induces lower ability | |
| of x-ray penetration when scanning the object with high BMI with higher | |
| possibility of photon starvation. | |
| Focal spot size of the proposed device is smaller than that of the predicate | |
| device. Smaller size is helpful for the improvement of resolution. | |
| The differences did not raise new safety and effectiveness concerns. | |
| Note 3 | The proposed device is configured with two kinds of Maximum Output Power. |
| One is same with the predicate device, one is smaller than the predicate device. | |
| Smaller power, lower mA or kV level in X-ray. | |
| The differences did not raise new safety and effectiveness concerns. | |
| Note 4 | The proposed device is configured with two kinds of patient table. One is same |
| with the predicate device, one is with lower load capacity than the predicate | |
| device. The two tables being a major component of the proposed device | |
| conform to the safety standards such as IEC 60601-1 series and satisfy the | |
| clinical use. | |
| The difference did not raise new safety and effectiveness concerns. | |
| Note 5 | Maximum slices generated per rotation of the proposed device is less than those |
| of the predicate device. The less slices, the longer scanning time for CT | |
| imaging. | |
| The difference did not raise new safety and effectiveness concerns. | |
| Note 6 | The predicate device can use this function both on axial scan mode and helical |
| scan mode. The proposed device only can use this function on helical scan | |
| mode. | |
| The difference did not raise new safety and effectiveness concerns. | |
| Note 7 | The predicate device can use this function both on axial scan mode and helical scan mode. The proposed device only can use this function on helical scan mode. |
| The difference did not raise new safety and effectiveness concerns. |
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Image /page/9/Picture/1 description: The image contains the logo for United Imaging. The logo consists of the words "UNITED IMAGING" in bold, sans-serif font, stacked on top of each other. To the right of the text is a stylized "U" shape, which is dark blue. The logo is simple and modern.
8. Performance Data
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 ATLAS Astound with uWS-CT Dual Energy Analysis 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)].
-
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.
-
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
- 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
-
NEMA XR 28-2018, 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
- 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)]
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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 in bold, dark blue font. To the right of the words is a stylized "U" symbol, also in dark blue, with a vertical line running through the center of the "U".
Software
- NEMA PS 3.1-3.20(2016): Digital Imaging and Communications in Medicine A (DICOM)
- A Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices
-
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 5: Tests for in vitro cytotoxicity.
- ISO 10993-10: 2010, Edition 3.0, Biological evaluation of medical devices Part A 10: Tests for irritation and skin sensitization.
Other Standards and Guidance
- 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
- A Laser Product - Conformance with IEC 60825-1; Guidance for Industry and FDA Staff (Laser Notice No. 56)
Software Verification and Validation
Software Documentation for a Moderate Level of Concern software per FDA's Guidance Document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" is included as 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 Image Evaluation
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The clinical image evaluation was performed under the proposed device. Sample image of head, neck, chest, abdomen, spine, hip, knee, pelvis and so on were provided with a board certified radiologist to evaluate the image quality in this submission. Each image was reviewed with a statement indicating that image quality are sufficient for clinical diagnosis.
Summary
The features described in this premarket submission are supported with the results of the testing mentioned above, the uCT ATLAS Astound with uWS-CT Dual Energy Analysis was found to have a safety and effectiveness profile that is similar to the predicate device.
9. Conclusions
Based on the comparison and analysis above, the proposed device has same intended use, similar performance, safety equivalence, 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.