(190 days)
No
The document describes standard CT imaging and post-processing techniques (dual energy analysis) and does not mention AI or ML.
No
The device is described as a diagnostic imaging system, specifically a computed tomography x-ray system, intended to produce cross-sectional images and for screening. It focuses on providing information for diagnosis, not on treatment or therapy.
Yes
Explanation: The device is a computed tomography x-ray system intended to produce cross-sectional images of the whole body and is explicitly stated to be used for low dose CT lung cancer screening for the early detection of lung nodules that may represent cancer, which are diagnostic purposes. The post-processing software also provides information on the chemical composition of scanned body materials, aiding in diagnosis.
No
The device description explicitly states that the proposed device includes "image acquisition hardware" and is a "CT system," indicating it is not solely software.
Based on the provided text, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the human body (like blood, urine, tissue). The description clearly states that this device is a computed tomography x-ray system that produces images of the inside of the body by using x-rays.
- The intended use is for imaging and diagnosis based on those images. The text describes producing cross-sectional images, screening for lung nodules, and analyzing image data. This is consistent with an in vivo imaging device, not an in vitro diagnostic device.
The device is an imaging system used to visualize structures within the body, not to analyze biological samples.
N/A
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.
uCT ATLAS 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 is applicable to head, whole body, cardiac, and vascular x-ray Computed Tomography.
uCT ATLAS has the capability to image a whole organ in a single rotation. Organs include, but not limited to head, heart, liver, kidney, pancreas, joints, etc.
uCT ATLAS 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 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 proposed device CT system with uWS-CT-Dual Energy Analysis includes image acquisition hardware, image acquisition, reconstruction and dual energy analysis software, and associated accessories.
The proposed CT system 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 computer system delivered with the CT scanner is able to run post processing applications optionally.
The Computed Tomography System family scanners referenced in this submission are comparable in indications for use, and are substantially equivalent in design, material, functionality, technology, energy source and are substantially equivalent to the predicate devices. The reason for this submission is to support the following additional function:
CT intervention provides real-time CT fluoroscopy at 12 IPS with in-room view and in-room X-ray control. It allows the user to adjust the scan parameters during operation, and scan modes can be switched according to technician's operation requirements. Entry path planning based on 2D and 3D images.
The CT guided intervention will be applicable for the UIH qualified CT systems. This indication will also be applicable for future qualified UIH CT systems.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT
Anatomical Site
whole body, head, cardiac, vascular, heart, liver, kidney, pancreas, joints
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 ATLAS Astound with uWS-CT Dual Energy Analysis and uCT ATLAS 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.
Summary:
The features described in this premarket submission are supported with the results of the testing mentioned above, the proposed device was found to have a safety and effectiveness profile that is similar to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): 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.
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.
0
November 29, 2023
Shanghai United Imaging Healthcare Co., Ltd. % Xin Gao Regulatory Affairs Manager No. 2258 Chengbei Rd., Jiading Industrial District SHANGHAI, SHANGHAI 201807 CHINA
Re: K231482
Trade/Device Name: uCT ATLAS Astound with uWS-CT-Dual Energy Analysis, uCT ATLAS 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: November 1, 2023 Received: November 1, 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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Radiologic Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
2
Indications for Use
510(k) Number (if known) K231482
Device Name
uCT ATLAS Astound with uWS-CT-Dual Energy Analysis, uCT ATLAS with uWS-CT-Dual Energy Analysis
Indications for Use (Describe)
uuCT 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.
uCT ATLAS 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 is applicable to head, whole body, cardiac, and vascular x-ray Computed Tomography.
uCT ATLAS has the capability to image a whole organ in a single rotation. Organs include, but not limited to head, heart, liver, kidney, pancreas, joints, etc.
uCT ATLAS 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 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
3
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4
Image /page/4/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.
K231482
510(k) SUMMARY
- Date of Preparation 1. November 1, 2023
-
- Sponsor Identification
Shanghai United Imaging Healthcare Co.,Ltd.
No.2258 Chengbei Rd. Jiading District, 201807, Shanghai, China Contact Person: Xin GAO Position: Regulatory Affairs Manager Tel: +86-021-67076888-5386 Fax: +86-021-67076889 Email: xin.gao@united-imaging.com
3. Identification of Subject Device
Device Name: uCT ATLAS Astound with uWS-CT-Dual Energy Analysis, uCT ATLAS with uWS-CT-Dual Energy Analysis Common Name: Computed Tomography X-ray System Model(s): uCT ATLAS Astound; uCT ATLAS Regulation Name: Computed Tomography X-ray System Regulation Number: 21 CFR 892.1750 Regulatory Class: II Product Code: JAK Review Panel: Radiology
4. Identification of Predicate/Reference Device(s)
Predicate Device(s) Device Name: uCT ATLAS Astound with uWS-CT-Dual Energy Analysis 510(k) Number: K223028 Regulation Name: Computed Tomography X-ray System Regulation Number: 21 CFR 892.1750 Regulatory Class: II Product Code: JAK Review Panel: Radiology
5
Image /page/5/Picture/1 description: The image contains the logo for United Imaging. The text "UNITED IMAGING" is in bold, dark teal font. To the right of the text is a stylized "U" shape, also in dark teal. The logo is simple and modern.
Device Name: uCT ATLAS with uWS-CT-Dual Energy Analysis 510(k) Number: K203448 Regulation Name: Computed Tomography X-ray System Regulation Number: 21 CFR 892.1750 Regulatory Class: II Product Code: JAK Review Panel: Radiology
Reference device(s): Device Name: uCT 760, uCT780 510(k) Number: K230162 Regulation Name: Computed Tomography X-ray System Regulation Number: 21 CFR 892.1750 Regulatory Class: II Product Code: JAK Review Panel: Radiology
5. Device Description:
The proposed device CT system with uWS-CT-Dual Energy Analysis includes image acquisition hardware, image acquisition, reconstruction and dual energy analysis software, and associated accessories.
The proposed CT system 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 computer system delivered with the CT scanner is able to run post processing applications optionally.
The Computed Tomography System family scanners referenced in this submission are comparable in indications for use, and are substantially equivalent in design, material, functionality, technology, energy source and are substantially equivalent to the predicate devices. The reason for this submission is to support the following additional function:
CT intervention provides real-time CT fluoroscopy at 12 IPS with in-room view and in-room X-ray control. It allows the user to adjust the scan parameters during operation, and scan modes can be switched according to technician's operation requirements. Entry path planning based on 2D and 3D images.
The CT guided intervention will be applicable for the UIH qualified CT systems. This indication will also be applicable for future qualified UIH CT systems.
6
Image /page/6/Picture/1 description: The image shows the logo for United Imaging. The logo consists of the words "UNITED IMAGING" in a bold, sans-serif font, stacked on top of each other. To the right of the words is a stylized "U" shape, which is dark gray and has a white line running vertically through the center. The logo is simple and modern, and the use of bold font and dark gray color gives it a strong and professional look.
Indications for Use 6.
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.
uCT ATLAS 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 is applicable to head, whole body, cardiac, and vascular x-ray Computed Tomography.
uCT ATLAS has the capability to image a whole organ in a single rotation. Organs include, but not limited to head, heart, liver, kidney, pancreas, joints, etc.
uCT ATLAS 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.
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Image /page/7/Picture/1 description: The image contains the logo for United Imaging. The logo consists of the words "UNITED IMAGING" in a bold, sans-serif font, stacked on top of each other. To the right of the text is a stylized "U" shape, which is divided vertically into two halves by a white line. The logo is simple and modern in design.
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
There is no change between the proposed device and the predicate device except CT-Guided Intervention function. Below is the comparison table between the proposed device, predicate device, and the reference device related to CT Guided Intervention function and the Hardware modifications due to the CT Guided Intervention:
| Software functions | Subject
devices | Predicate devices
(K223028 and
K203448) | Reference device
#1 (K230162) | Discussion |
|--------------------------|--------------------|-----------------------------------------------|----------------------------------|------------|
| Single Axial Scan | Yes | -- | Yes | Same |
| Single Helical Scan | Yes | -- | Yes | Same |
| Fluoro Mode | Yes | -- | Yes | Same |
| Continuous Mode | Yes | -- | Yes | Same |
| 2D & 3D path
planning | Yes | -- | Yes | Same |
| 3D image Guidance | Yes | -- | Yes | Same |
| Hardware addition | Subject
devices | Predicate devices
(K223028 and
K203448) | Reference device
#1 (K230162) | Discussion |
| Scanning room
monitor | Yes | -- | Yes | Same |
| Exposure Foot Pedal | Yes | -- | Yes | Same |
| Hand Cart | Yes | -- | Yes | Same |
| Suspension Gear | Yes | -- | Yes | Same |
| Couch Side Controller | Yes | -- | Yes | Same |
8. Performance Data
Non-Clinical Testing
8
Image /page/8/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 words is a stylized "U" symbol. The symbol is made up of two vertical bars with a horizontal bar connecting them at the top.
Non-clinical testing including dosimetry and image performance tests were conducted for the uCT ATLAS Astound with uWS-CT Dual Energy Analysis and uCT ATLAS 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)
-
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 ANSI AAMI IEC 60601-1-2:2014 [Including AMD 1:2021] Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances -Requirements and tests [Including Amendment 1 (2021)]
- 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
- A IEC 60825-1: 2014, Edition 3.0, Safety of laser products - Part 1: Equipment classification and requirements.
-
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.
-
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
- A NEMA XR 29-2013, Standard Attributes on CT Equipment Related to Dose Optimization and Management
- A IEC 61223-3-5:2019 Evaluation and routine testing in medical imaging departments - Part 3-5: Acceptance and constancy tests - Imaging performance of computed tomography X-ray equipment
Software
- A NEMA PS 3.1-3.20(2016): Digital Imaging and Communications in Medicine (DICOM)
-
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
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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 also in bold. The color of the logo is a dark teal.
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 Guidance
- A ISO 14971: 2019, Edition 3.0, Medical Devices - Application of risk management to medical devices
- Code of Federal Regulations, Title 21, Part 820 Quality System Regulation A
- 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
In this submission, following reports related to image quality metrics and CT Guided Intervention function are renewed and submitted:
- A Biocompatibility Report
- A IEC 61223-3-5 Test Report
-
Performance Evaluation for CT Guided Intervention
Summarv
The features described in this premarket submission are supported with the results of the testing mentioned above, the proposed device 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. The proposed device is determined to be Substantially Equivalent (SE) to the predicate device.