(53 days)
No
The description mentions traditional image reconstruction algorithms (filter back-projection, iterative denoising) and artifact correction algorithms, but does not mention AI or ML.
No
Explanation: The device is described as a diagnostic imaging system (Computed Tomography X-ray System) that produces images for assessment, not for direct treatment or therapy.
Yes
Explanation: The device is a computed tomography X-ray system that produces cross-sectional images of the body for diagnostic purposes, as indicated by its intended use to reconstruct images to be used by post-processing applications and the mention of "diagnostic quality" in performance studies. CT scans are a primary diagnostic tool in medicine.
No
The device description clearly outlines multiple hardware components including a Gantry, X-ray System, Data Management System, Patient Table, Console, Power Supply Cabinet, and Image Processing Computer, in addition to the software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the system is for producing cross-sectional images of the body using X-ray transmission data. This is a diagnostic imaging device, not a device used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.
- Device Description: The description details a CT scanner, which is an imaging modality. It describes the physical components and how it generates images from X-ray data. This aligns with an imaging device, not an IVD.
- Input Imaging Modality: The input is Computed Tomography X-ray, which is an imaging technique, not a method for analyzing biological specimens.
IVD devices are specifically designed to perform tests on samples taken from the body to provide diagnostic information. This device is designed to create images of the inside of the body using external energy (X-rays).
N/A
Intended Use / Indications for Use
The uCT Computed Tomography X-ray System uCT530/550 is a computed tomography X-ray system intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes and indicated for the whole body, including head, neck, cardiac (calcium scoring) and vascular.
Product codes
JAK
Device Description
The uCT 530/uCT 550 is a multi-slice X-ray computed tomography scanner which features a continuously rotating tube-detector system and functions according to the fan beam principle. The system provides the filter back-projection (FBP) algorithm to reconstruct images in DICOM format, which can be used by post-processing applications.
The system consists of the Gantry, X-ray System, Data Management System, Patient Table, Console, Power Supply Cabinet, Image Processing Computer, and Software. The system software is a program used for patient management, data management, X-ray scan control, image reconstruction, and image archive.
A motorized patient table moves the patient through a circular opening in the Gantry. As the patient passes through the Gantry, a source of x rays rotates around the inside of the circular opening. Detectors on the exit side of the patient record the X rays exiting the section of the patient's body being irradiated as an X-ray "snapshot". Many different "snapshots" (angles) are collected during one complete rotation. The data are sent to a computer to reconstruct all of the individual "snapshots" into a cross-sectional image (slice) of the internal organs and tissues for each complete rotation of the source of x rays.
There are two features for denoising and reduce metal artifact, which are KARL iterative denoising reconstruction algorithm and MAC Metal artifact correction algorithm.
This proposed device includes two models: uCT 530. uCT 550.The differences between the two models are as follows:
The uCT 530, uCT 550 have been previously cleared by FDA via K181414. The modifications performed on the uCT 530, uCT 550 (K181414) in this submission are due to the addition of the calcium scoring scan function. Meanwhile some component descriptions have been updated. The modifications are listed as follows:
- Indications for use: cardiac (calcium scoring) is stated in this submission.
- Hardware: Vital Signal Module (VSM) hardware is added to the system.
- Software: workflow of Calcium scoring scan is added to the system.
- Component Descriptions:
- Update the description of DMS frame and detector building block = (DBB).
- Update the description of the console PC' CPU.
- . Update the description of the gantry control PC' CPU.
- Update the description of the monitor's size.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Computed Tomography X-ray
Anatomical Site
Body, including head, neck, cardiac, and vascular.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Testing including dosimetry and image performance tests were conducted.
Performance Verification included:
- Clinical Evaluation for sample clinical images evaluation
- AEC Test Report for AEC performance study
- MAC Performance Evaluation Report
- ECG R-Wave Detection Algorithm Performance Evaluation Report
The 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.
No Clinical Study is included in this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1750 Computed tomography x-ray system.
(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Shanghai United Imaging Healthcare Co., Ltd. % Xin Gao RA Manager No. 2258 Chengbei Rd., Jiading Industrial District Shanghai, 201807 CHINA
February 25, 2020
Re: K200016
Trade/Device Name: uCT 530, uCT 550 Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: Class II Product Code: JAK Dated: January 2, 2020 Received: January 3, 2020
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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
1
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 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.
For
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and 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 530, uCT 550
Indications for Use (Describe)
The uCT Computed Tomography X-ray System uCT530/550 is a computed tomography X-ray system intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes and indicated for the whole body, including head, neck, cardiac (calcium scoring) and vascular.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/2 description: The image contains the logo for United Imaging. The text "UNITED IMAGING" is stacked on top of each other and is in a bold, sans-serif font. To the right of the text is a stylized "U" shape that is dark gray. The logo is simple and modern.
510 (k) SUMMARY
-
- Date of Preparation February 15, 2020
2. Sponsor Identification
Shanghai United Imaging Healthcare Co.,Ltd.
No.2258 Chengbei Rd. Jiading District, 201807, Shanghai, China
Contact Person: Xin Gao Position: RA Manager Tel: +86-021-67076888-5386 Fax: +86-021-67076889 Email: xin.gao@united-imaging.com
3. Identification of Proposed Device
Trade Name: uCT 530, uCT 550 Common Name: Computed Tomography X-ray System Model(s): uCT 530, uCT 550
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 Device(s)
Primary Predicate Device:
510(k) Number: K181414 Device Name: uCT Computed Tomography X-Ray System Model(s): uCT 530, uCT 550
Regulatory Information Regulation Number: 21 CFR 892.1750 Regulation Name: Computed Tomography X-ray System Regulatory Class: II Product Code: JAK Review Panel: Radiology
Secondary Predicate Device:
510(k) Number: K172135 Device Name: uCT Computed Tomography X-Ray System Model(s): uCT 760, uCT 780
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Image /page/4/Picture/1 description: The image shows the logo for United Imaging. The words "UNITED IMAGING" are stacked on top of each other in a bold, sans-serif font. To the right of the words is a stylized "U" shape, which is also in a bold font. The logo is simple and modern, and the colors are muted.
Regulatory Information Regulation Number: 21 CFR 892.1750 Regulation Name: Computed Tomography X-ray System Regulatory Class: II Product Code: JAK Review Panel: Radiology
5. Device Description:
The uCT 530/uCT 550 is a multi-slice X-ray computed tomography scanner which features a continuously rotating tube-detector system and functions according to the fan beam principle. The system provides the filter back-projection (FBP) algorithm to reconstruct images in DICOM format, which can be used by post-processing applications.
The system consists of the Gantry, X-ray System, Data Management System, Patient Table, Console, Power Supply Cabinet, Image Processing Computer, and Software. The system software is a program used for patient management, data management, X-ray scan control, image reconstruction, and image archive.
A motorized patient table moves the patient through a circular opening in the Gantry. As the patient passes through the Gantry, a source of x rays rotates around the inside of the circular opening. Detectors on the exit side of the patient record the X rays exiting the section of the patient's body being irradiated as an X-ray "snapshot". Many different "snapshots" (angles) are collected during one complete rotation. The data are sent to a computer to reconstruct all of the individual "snapshots" into a cross-sectional image (slice) of the internal organs and tissues for each complete rotation of the source of x rays.
There are two features for denoising and reduce metal artifact, which are KARL iterative denoising reconstruction algorithm and MAC Metal artifact correction algorithm.
| Spec.
Model | HV Power | Rotation speed | Minimum
slice thickness | Maximum slices
generated per rotation |
|----------------|----------|------------------------------------|----------------------------|------------------------------------------|
| uCT 530 | 50kW | Up to 0.5 sec per
360° rotation | 0.55mm | 40 |
| uCT 550 | 50kW | Up to 0.5 sec per
360° rotation | 0.55mm | 80 |
This proposed device includes two models: uCT 530. uCT 550.The differences between the two models are as follows:
The uCT 530, uCT 550 have been previously cleared by FDA via K181414. The modifications performed on the uCT 530, uCT 550 (K181414) in this submission are due to the addition of the calcium scoring scan function. Meanwhile some component descriptions have been updated. The modifications are listed as follows:
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Image /page/5/Picture/1 description: The image contains the logo for United Imaging. The text "UNITED" is stacked on top of the text "IMAGING". To the right of the text is a stylized letter "U" that is dark gray. The logo is simple and modern.
- Indications for use: cardiac (calcium scoring) is stated in this submission. >
-
Hardware: Vital Signal Module (VSM) hardware is added to the system.
-
Software: workflow of Calcium scoring scan is added to the system.
-
Component Descriptions:
- Update the description of DMS frame and detector building block = (DBB).
- Update the description of the console PC' CPU.
- . Update the description of the gantry control PC' CPU.
- Update the description of the monitor's size.
Indications for Use 6.
The uCT Computed Tomography X-ray System uCT 530/550 is a computed tomography x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes and indicated for the whole body, including head, neck, cardiac (calcium scoring) and vascular.
7. Comparison of Technological Characteristics with the Predicate Devices
Table 1 below provides a comparison of the technological characteristics of the proposed device in comparison to the Primary Predicate Device:
| ITEM | Proposed Device
uCT 530, uCT 550 | Primary Predicate Device:
uCT 530, uCT 550 (K181414) | Remark |
|----------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|
| General | | | |
| Product Code | JAK | JAK | Same |
| Regulation No. | 21 CFR 892.1750 | 21 CFR 892.1750 | Same |
| Class | II | II | Same |
| Intended Use | The uCT Computed Tomography
X-ray System uCT 530/550 is a
computed tomography x-ray
system intended to produce cross-
sectional images of the body by
computer reconstruction of x-ray
transmission data taken at different
angles and planes and indicated
for the whole body, including
head, neck, cardiac
(calcium scoring) and vascular. | The uCT Computed Tomography
X-ray System uCT 530/550 is a
computed tomography x-ray
system intended to produce cross-
sectional images of the body by
computer reconstruction of x-ray
transmission data taken at
different angles and planes and
indicated for the whole body
(including head, neck, vascular). | Note 1 |
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Image /page/6/Picture/1 description: The image contains the logo for United Imaging. The words "UNITED" and "IMAGING" are stacked on top of each other in a bold, sans-serif font. To the right of the text is a stylized "U" symbol, which is composed of two vertical lines and a horizontal line in the middle, creating a shape that resembles a "U" with a crossbar.
| Specifications | |||
|---|---|---|---|
| Scan Regime | Continuous Rotation | Continuous Rotation | Same |
| Scan Modes | Scout scan | ||
| Axial scan | |||
| Helical scan | |||
| Contrast enhanced scan | |||
| Stationary perfusion scan | |||
| Gating scan | Scout scan | ||
| Axial scan | |||
| Helical scan | |||
| Contrast enhanced scan | |||
| Stationary perfusion scan | Note 2 | ||
| Detector | |||
| Material | Solid-state GOS | Solid-state GOS | Same |
| Z-plane | |||
| coverage | 22mm | 22mm | Same |
| Size of detector | |||
| element in Z- | |||
| plane | 0.55mm | 0.55mm | Same |
| Number of | |||
| element per row | 864 | 864 | Same |
| Number of | |||
| detector row | 40 | 40 | Same |
| Maximum | |||
| slices generated | |||
| per rotation | |||
| (multi-slice | |||
| capability) | 40 for uCT 530 | ||
| 80 for uCT 550 | 40 for uCT 530 | ||
| 80 for uCT 550 | Same | ||
| Minimum slice | |||
| thickness | 0.55mm | 0.55mm | Same |
| Maximum | |||
| sampling rate | Up to 4800 views per 360° | Up to 4800 views per 360° | Same |
| Tube anode | |||
| storage capacity | 5.3MHU | 5.3MHU | Same |
| Maximum | |||
| cooling rate | 815 kHU/min | 815 kHU/min | Same |
| Focal spot size | 0.5x1.0mm | ||
| 1.0x1.0mm | 0.5x1.0mm | ||
| 1.0x1.0mm | Same |
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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 bold, sans-serif font, stacked on top of each other. To the right of the text is a stylized "U" symbol, which is dark blue and has a white line running vertically through the center.
| Power | 50kW | 50kW | Same |
|---|---|---|---|
| mA Range | 10-420mA | 10-420mA | Same |
| kV Settings | 70, 80, 100, 120, 140 | 70, 80, 100, 120, 140 | Same |
| Aperture | 700mm | 700mm | Same |
| Rotation speed | Up to 0.5 sec per 360° rotation | Up to 0.5 sec per 360° rotation | Same |
| Gantry Tilt | $\pm$ 30°with 0.5 increment | $\pm$ 30°with 0.5 increment | Same |
| Scannable | |||
| range | 1700 mm | 1700 mm | Same |
| Horizontal | |||
| motion range | 2180 mm | 2180 mm | Same |
| Table | |||
| Horizontal | |||
| Speed | Up to 200mm/sec | Up to 200mm/sec | Same |
| Vertical motion | |||
| range | 480 mm-950 mm from the floor | 480 mm-950 mm from the floor | Same |
| Vertical speed | Up to 40 mm/sec | Up to 40 mm/sec | Same |
| Table | |||
| Horizontal | |||
| Position | |||
| accuracy | $\pm$ 0.25mm | $\pm$ 0.25mm | Same |
| Table | |||
| Maximum table | |||
| load | 205kg | 205kg | Same |
| Image Spatial | |||
| Resolution | High mode: |
20 lp/cm @ MTF 0% | High mode:
20 lp/cm @ MTF 0% | Same |
| | 16.5 $\pm$ 1.7 lp/cm @ MTF10% | 16.5 $\pm$ 1.7 lp/cm @ MTF10% | |
| | 11.5 $\pm$ 1.2 lp/cm @ MTF50% | 11.5 $\pm$ 1.2 lp/cm @ MTF50% | |
| Image Noise | 3.0 $\pm$ 0.5 HU at 120 kV, 5 mm slice
thickness, CTDIvol 28.9 mGy | 3.0 $\pm$ 0.5 HU at 120 kV, 5 mm slice
thickness, CTDIvol 28.9 mGy | Same |
| CT Number
Display Range | -1024 ~+8191 HU | -1024 ~+8191 HU | Same |
| Scan Field of
View | Up to 500 mm | Up to 500 mm | Same |
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Image /page/8/Picture/1 description: The image contains the logo for United Imaging. The logo consists of the words "UNITED IMAGING" in bold, sans-serif font, stacked on top of each other. To the right of the text is a stylized "U" symbol, which is dark blue and has a white vertical line running through the center.
| 600mm with extend FOV | 600mm with extend FOV | ||
|---|---|---|---|
| Reconstruction | |||
| Field of View | 40mm-500mm | ||
| 40mm-600mm with extend FOV | 40mm-500mm | ||
| 40mm-600mm with extend FOV | Same | ||
| Maximum | |||
| scannable | |||
| length | 1700mm | 1700mm | Same |
| Image Matrix | Up to 1024 x 1024 | Up to 1024 x 1024 | Same |
| Reconstructed | |||
| slice thickness | 0.55mm,1.1mm,2.2mm,5.5mm,11 | ||
| mm (axial) | |||
| 0.55-10mm(helical) | 0.55mm,1.1mm,2.2mm,5.5mm,11 | ||
| mm (axial) | |||
| 0.55-10mm(helical) | Same | ||
| Pitch | 0.1~2.0 | 0.1~2.0 | Same |
| Maximum | |||
| continuous | |||
| exposure time | Up to 100seconds | Up to 100seconds | Same |
| VSM | Operating voltage: 3.7V DC | ||
| Common-mode rejection [allowed | |||
| 10V(rms) line-frequency noise]: | |||
| ≤1mV (p-v RTI) | |||
| Signal reduction of the injected | |||
| frequency: 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 |
-
IEC 60601-1-2:2014, Medical Electrical Equipment - Part 1-2: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Compatibility - Requirements And Tests
-
IEC 60825-1 Edition 2.0 2007-03, Safety Of Laser Products - Part 1: Equipment Classification, And Requirements
Product Particular Standards
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Image /page/12/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 font. The color of the text and the "U" shape is a dark teal.
- NEMA XR 25-2010, Computed Tomography Dose Check >
- A NEMA XR 28-2013, 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
- IEC 60601-1-3 Edition 2.1 2013-04, Medical Electrical Equipment Part 1-3: > General Requirements For Basic Safety And Essential Performance -Collateral Standard: Radiation Protection In Diagnostic X-ray Equipment
-
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
Performance Verification
- Clinical Evaluation for sample clinical images evaluation A
- A AEC Test Report for AEC performance study
- A MAC Performance Evaluation Report
-
ECG R-Wave Detection Algorithm Performance Evaluation Report
Software
-
NEMA PS 3.1-3.20(2011): Digital Imaging and Communications in Medicine (DICOM)
-
IEC 62304: Medical Device Software - software life cycle process
-
Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices
-
Content of Premarket Submissions for Management of Cybersecurity in Medical Devices
Biocompatibility
- ISO 10993-5 Third Edition 2009-06-01, Biological Evaluation Of Medical A Devices - Part 5: Tests For In Vitro Cytotoxicity
- A ISO 10993-10 Third Edition 2010-08-01, Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization
Other Standards and Guidances
- ISO 14971: Medical Devices Application of risk management to medical A devices
-
Code of Federal Regulations, Title 21, Part 820 - Quality System Regulation
- Code of Federal Regulations, Title 21, Subchapter J Radiological Health A
- A Laser Products - Conformance with IEC 60825-1 and IEC 60601-2-22; Guidance for Industry and FDA Staff (Laser Notice No. 50)
- 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
Software Verification and Validation
Software documentation for a Moderate Level of Concern software per FDA' Guidance Document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" is included as a part of this submission.
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Image /page/13/Picture/1 description: The image contains the logo for United Imaging. The logo consists of the words "UNITED IMAGING" stacked on top of each other in a bold, sans-serif font. To the right of the text is a stylized "U" shape, which is also in a bold font. The color of the text and the "U" shape is a dark gray.
The risk analysis was completed and risk control was implemented to mitigate identified hazards. The testing results show that all the software specifications have met the acceptance criteria. Verification and validation testing of the proposed device was found acceptable to support the claim of substantial equivalence.
UNITED IMAGING HEALTHCARE conforms to the Cybersecurity requirements by implementing a process of preventing unauthorized access, modification, misuse or denial of use, or unauthorized use of information that is stored, accessed, or transferred from a medical device to an external recipient. Cybersecurity information in accordance with guidance document "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices" is included in this submission.
Clinical Testing
No Clinical Study is included in this submission.
Summary
The features described in this premarket submission are supported with the results of the testing mentioned above, the uCT 530/uCT 550 was found to have a safety and effectiveness profile that is similar to the predicate device.
Conclusions 9.
Based on the comparison and analysis above, the proposed device has same intended use, same performance, equivalence safety and effeteness as the predicate devices. The differences above between the proposed device and predicate devices do not affect the intended use, the technology characteristics, safety and effectiveness. And no issues are raised regarding to safety and effectiveness. The proposed device is determined to be Substantially Equivalent (SE) to the predicate devices.