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.

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.

AI/ML Overview

It appears that the provided document is a 510(k) summary for a medical device (uCT ATLAS Astound with uWS-CT-Dual Energy Analysis) being submitted to the FDA. While it discusses the device's indications for use, technological characteristics compared to a predicate device, and various non-clinical performance data (electrical safety, EMC, software, biocompatibility, etc.), it does not contain detailed information about a specific clinical study aimed at proving the device meets quantitative acceptance criteria related to its performance in terms of diagnostic accuracy or reader improvement.

The section titled "Clinical Image Evaluation" mentions that "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." This describes a qualitative assessment of image quality by a radiologist, rather than a rigorous study with predefined acceptance criteria, statistical analysis, and a detailed breakdown of test set characteristics as requested.

Therefore,Based on the provided document, the specific details required to answer your request regarding acceptance criteria and the study that proves the device meets them (especially in the context of diagnostic performance or human reader improvement with AI assistance) are not present. The document focuses on showing substantial equivalence to a predicate device primarily through technical comparisons and non-clinical testing, along with a high-level, qualitative statement about clinical image evaluation.

To directly answer your questions based only on the provided text:

1. A table of acceptance criteria and the reported device performance:

Not provided. The document does not list quantitative acceptance criteria for diagnostic performance or reported performance metrics against such criteria. It states that non-clinical tests (dosimetry, image performance) verified the device met design specifications and that image quality was "sufficient for clinical diagnosis" based on a radiologist's review.

2. Sample size used for the test set and the data provenance:

Sample size: Not specified for the "Clinical Image Evaluation" or any other diagnostic performance test.
Data provenance: Not specified (e.g., country of origin, retrospective/prospective). The general statement "Sample image of head, neck, chest, abdomen, spine, hip, knee, pelvis and so on were provided" does not offer these details.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Number of experts: Singular ("a board certified radiologist").
Qualifications: "board certified radiologist." No mention of years of experience.
Ground Truth Establishment: Not described. The radiologist "evaluate[d] the image quality" and provided "a statement indicating that image quality are sufficient for clinical diagnosis." This is an evaluation of image quality, not the establishment of a ground truth for a specific diagnostic task from a test set.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

None described. Given only one radiologist is mentioned for image quality evaluation, formal adjudication is not implied.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

No, an MRMC comparative effectiveness study was not explicitly mentioned or detailed. The device is a CT system with dual-energy analysis software; the document does not describe AI assistance for human readers or a study evaluating reader improvement.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

No standalone diagnostic performance study by the algorithm is described. The software performs image post-processing and analysis (e.g., generating mono-energetic images, material base pairs, virtual non-contrast images), but there's no mention of a study where the algorithm itself made a diagnosis or provided a quantitative output that was evaluated against ground truth without human input.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Not explicitly stated for diagnostic performance. The "Clinical Image Evaluation" relied on a radiologist's qualitative judgment of "image quality" and its sufficiency for "clinical diagnosis," which isn't a direct ground truth for disease presence/absence.

8. The sample size for the training set:

Not applicable/Not provided. The document describes a CT scanner and post-processing software. While the device incorporates "Deep IR (also named AIIR)" which is described as combining "model-based iterative reconstruction and deep learning technology," there is no mention of a separate "training set" in the context of device performance claims or a diagnostic AI component being evaluated. This deep learning component appears to be part of the image reconstruction process, not necessarily a diagnostic AI algorithm that is trained on a specific dataset with ground truth labels for a clinical condition.

9. How the ground truth for the training set was established:

Not applicable/Not provided. (See point 8).

In summary, the provided FDA 510(k) summary focuses on demonstrating substantial equivalence to a predicate device through technical specifications, non-clinical tests, and a qualitative clinical image evaluation. It does not present the type of detailed clinical study data, acceptance criteria, or ground truth establishment relevant to evaluating diagnostic AI performance or human reader improvement with AI assistance as requested in your prompt.

Summary

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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

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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

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Indications for Use

510(k) Number (if known)

K223028

Device Name

uCT ATLAS Astound with uWS-CT-Dual Energy Analysis

Indications for Use (Describe)

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

K223028

1. 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

1. 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 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

6. Indications for Use

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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" 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.

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 to0.25s/rotation82cm bore	Rotation speed: up to0.25s/rotation82cm bore	Same
Detector	40mm DetectorMaterial: Solid-state GOS80 rows,936 channels/rowSize of detector element inZ-plane: 0.5mm	160mm DetectorMaterial: Solid-state GOS320 rows,936 channels/rowSize of detector element inZ-plane: 0.5mm	Note 1
X-ray tube	60, 70, 80, 100, 120, 140 kVmA range: 10mA-667mA,10mA-833mA(option)	60, 70, 80, 100, 120, 140 kVmA range: 10mA-833mA	Note 2
ITEM	Proposed Device	Predicate Device	Discussion
	Anode heat capacity:30MHU equivalently	Anode heat capacity:30MHU equivalently
	Maximum anode heatdissipation:20kW(1696kHU/min)	Maximum anode heatdissipation:20kW(1696kHU/min)
	Focal spot size:0.4mm × 0.7mm0.6mm × 0.7mm1.1mm × 1.2mm	Focal spot size:0.4mm × 0.8mm0.6mm × 0.8mm1.1mm × 1.2mm
High VoltageGenerator	80kW, 100kW(option)60, 70, 80, 100, 120, 140 kV	100kW60, 70, 80, 100, 120, 140 kV	Note 3
Patient Table	Max load capacity205kg (StandardConfiguration);318kg (High Configuration)	Max load capacity318kg	Note 4
ReconstructionField of View	40-500mm40-600mm with extendedFOV	40-500mm40-600mm with extendedFOV	Same
Maximum slicesgenerated perrotation	160	640	Note 5
Functions
Low Dose CTLung CancerScreeningProtocol	Yes	Yes	Same
uAI Vision-EasyPositioningEasyISO	Yes	Yes	Same
Easy Range	Yes	Yes	Same
Injector Linkage	Yes	Yes	Same
RemoteAssistance	Yes	Yes	Same
ITEM	Proposed Device	Predicate Device	Discussion
Auto ALARAkVp	Yes	Yes	Same
	Auto ALARA mA	Yes	Yes
Organ-Based AutoALARA mA	Yes	Yes	Same
	Deep IR (which isalso named AIIR)	Yes	Yes
KARL 3D		Yes	Yes
CardioXphase	Yes	Yes	Note 6
CardioCapture	Yes	Yes	Note 7
Metal ArtifactCorrection	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 ScanDual 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 BaseMaterial Pair	Yes	Yes	Same
Image Registration	Yes	Yes	Same
Effective Atomic Number Images	Yes	Yes	Same
• Component analysis of kidneystones, uric acid stones or non-uric acid stones
• Component analysis of jointgout, uric acid gout or non-uricacid 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

Same

Justification
Note 1	The detector dimension of the proposed device is shorter than that of thepredicate device. Detector rows of the proposed device is less than those of thepredicate device. The shorter detector Z-plane coverage, the longer scanningtime for CT imaging. The smaller number of rows, the less image informationobtained.The difference did not raise new safety and effectiveness concerns.
Note 2	The proposed device is configured with two different ranges of mA ranges. Oneis 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 abilityof x-ray penetration when scanning the object with high BMI with higherpossibility of photon starvation.Focal spot size of the proposed device is smaller than that of the predicatedevice. 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 samewith the predicate device, one is with lower load capacity than the predicatedevice. The two tables being a major component of the proposed deviceconform to the safety standards such as IEC 60601-1 series and satisfy theclinical 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 thoseof the predicate device. The less slices, the longer scanning time for CTimaging.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 helicalscan mode. The proposed device only can use this function on helical scanmode.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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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 symbol that resembles the letter "U" or a shield, with a vertical white line running down the center, dividing the shape into two halves. The overall design is clean and modern.

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.

Regulation Number and Section

§ 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.