Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The description mentions standard image reconstruction algorithms (filter back-projection) and iterative denoising/metal artifact correction algorithms, but does not explicitly mention or imply the use of AI or ML.

Therapeutic

No
The device is described as an imaging system (CT scanner) used to produce images of the body for diagnostic purposes, not to treat or alleviate a medical condition.

Diagnostic

Yes.
The device is a Computed Tomography X-ray System intended to produce cross-sectional images of the body, which are used for diagnostic purposes by recreating internal images from X-ray data.

SaMD (Software as a Medical Device)

No

The device description explicitly lists multiple hardware components including the Gantry, X-ray System, Data Management System, Patient Table, Console, Power Supply Cabinet, and Image Processing Computer, in addition to the software. This indicates it is a hardware system with integrated software, not a software-only medical device.

IVD (In Vitro Diagnostic)

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. They are used to provide information for diagnosis, monitoring, or screening.
Device Function: The description clearly states that the uCT Computed Tomography X-ray System uCT 530/550 is an imaging system that uses X-rays to produce cross-sectional images of the body. It works by reconstructing data from X-ray transmission through the body.
No Sample Analysis: The device does not analyze any samples taken from the body. It directly interacts with the body using X-rays.

Therefore, this device falls under the category of medical imaging devices, not in vitro diagnostics.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for 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, 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, Xray 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 crosssectional 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.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

X-ray transmission data

Anatomical Site

whole body (including head, neck, 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 for the uCT 530/uCT 550 during the product development.
A Clinical Evaluation for sample clinical images evaluation;
A AEC Test Report for AEC performance study.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K172135

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font size below that.

Shanghai United Imaging Healthcare Co., Ltd. % Shumei Wang OM & RA Director No. 2258 Chengbei Rd., Jiading Industrial District Shanghai. 201807 CHINA

August 14th, 2018

Re: K181414

Trade/Device Name: uCT 530, uCT 550 Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: May 28, 2018 Received: May 30, 2018

Dear Shumei Wang:

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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Jeff Rodgers

for Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

2

Indications for Use

510(k) Number (if known) K181414

Device Name uCT 530, uCT 550

Indications for Use (Describe)

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).

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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510 (k) SUMMARY

Date of Preparation 1. May 28, 2018

2. Sponsor Identification

Shanghai United Imaging Healthcare Co.,Ltd. No.2258 Chengbei Rd. Jiading District, 201807, Shanghai, China

Contact Person: Shumei Wang Position: QM&RA VP Tel: +86-021-67076888-6776 Fax: +86-021-67076889 Email: shumei.wang@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

Identification of Predicate Device(s) 4.

Predicate Device

510(k) Number: K172135 Device Name: uCT Computed Tomography X-Ray System Model(s): uCT 760, uCT 780

Regulatory Information

Regulation Number: 21 CFR 892.1750 Regulation Name: Computed Tomography X-ray System Regulatory Class: II Product Code: JAK Review Panel: Radiology

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Image /page/4/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" shape, which is also in a bold font. The logo is simple and modern, and the colors are muted.

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, Xray 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 crosssectional 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:

Indications for Use 6.

The uCT Computed Tomography X-ray System uCT 530/uCT 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).

7. Comparison of Technological Characteristics with the Predicate Devices

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Image /page/5/Picture/1 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, which is also in a bold font. The logo is simple and modern, and the colors are muted.

The uCT 530/uCT 550 Computed Tomography X-ray system has the same indications for use as the predicate device uCT 760/uCT 780. The fundamental scientific technology of the proposed device is same as the predicate device.

Table 1 below provides a comparison of the technological characteristics of the proposed device in comparison to the predicate device.

ITEM	Proposed Device	Predicate Device	Remark
	uCT 530, uCT 550	uCT 760, uCT 780
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
uCT530/uCT550 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).	The uCT Computed
Tomography X-ray System 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 and vascular).	Note
No.1
Specifications
Scan Regime	Continuous Rotation	Continuous Rotation	Same
Scan Modes	Scout
Axial Scan
Helical Scan	Scout
Axial Scan
Helical Scan	Same
Detector
Material	Solid-state GOS	Solid-state GOS	Same
Z-plane
coverage	22mm	40mm	Note
No.2
Size of detector
element in Z-
plane	0.55mm	0.5mm	Note
No.3
Number of
element per row	864	936	Note
No.4
Number of
detector row	40	80	Note
No.5
Maximum slices
generated per
rotation (multi-
slice capability)	40 for uCT 530
80 for uCT 550	128 for uCT 760
160 for uCT 780	Note
No.6
Minimum slice
thickness	0.55mm	0.625mm for uCT 760
0.5mm for uCT 780	Note No.7
Maximum
sampling rate	Up to 4800 views per 360 °	Up to 4800 views per 360 °	Same
Tube anode
storage capacity	5.3MHU	7.5MHU	Note No.8
Maximum
cooling rate	815 kHU/min	1386 kHU/min	Note No.9
Focal spot size	0.5x1.0mm
1.0x1.0mm	0.7x0.7mm
1.0x1.0mm	Note No.10
Power	50kW	80kW for uCT 760
100 kW for uCT 780	Note No.11
mA Range	10-420mA	6-667mA for uCT 760
6-833mA for uCT 780	Note No.12
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 0.35 sec per 360 °
rotation for uCT 760
Up to 0.3 sec per 360 °
rotation for uCT 780	Note No.13
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%
16.5 $\pm$ 1.7 lp/cm @ MTF10%
11.5 $\pm$ 1.2 lp/cm @ MTF50% | High mode:
20 lp/cm @ MTF 0%
16.5 $\pm$ 1.7 lp/cm @ MTF10%
11.5 $\pm$ 1.2 lp/cm @ MTF50% | Same |
| 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
29.1mGy | Note No.14 |
| CT Number
Display Range | -1024 +8191 HU | -1024 +8191 HU | Same |
| Scan Field of View | Up to 500 mm
600mm with extend FOV | Up to 500 mm
600mm with extend FOV | Same |
| 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
0.55mm,1.1mm,2.2mm,5.5mm
,11mm (axial)
0.55-10mm(helical) | Up to 1024 x 1024 | Same |
| Reconstructed
slice thickness | | uCT 760:
0.625mm,1.25mm,2.5mm,5mm,10mm (axial)
0.625-10mm(helical)
uCT 780:
0.5mm,0.625mm,1.25mm,2.5mm,5mm,10mm (axial)
0.5-10mm (helical) | Note
No.15 |
| Pitch | 0.12.0 | 0.12.0 | Same |
| Maximum
continuous
exposure time | Up to 100seconds | Up to 100seconds | Same |
| Safety | | | |
| Electrical Safety | Comply with ES60601-1 | Comply with ES60601-1 | Same |
| EMC | Comply with IEC60601-1-2 | Comply with IEC60601-1-2 | Same |
| Biocompatibility | Patient Contact Materials were
tested and demonstrated no
cytotoxicity (ISO 10993-5), no
evidence for irritation and
sensitization (ISO 10993-10). | Patient Contact Materials
were tested and demonstrated
no cytotoxicity (ISO 10993-
5), no evidence for irritation
and sensitization (ISO 10993-
10). | Same |
| Clinical | Sample clinical images for proposed devices are provided in Section 36
Clinical Evaluation. Electronic file for each image are provide in MISC
Folder. | | |
| Justification | | | |
| Note ID | Justification | | |
| Note 1 | The uCT 530 and uCT550 is indicated for computed tomography of the
whole body including head, neck, and vascular but not including cardiac
which does not affect safety and effectiveness the computed tomography
system. | | |
| Note 2 | Provides the shorter detector Z-plane coverage induces longer scanning
time for CT imaging, which does not affect safety and effectiveness. | | |
| Note 3 | Provides the bigger minimum detector element size that induces lower z-
plane spatial resolution for CT imaging, which does not affect safety and
effectiveness. | | |

Table 1 Comparison of Technological Characteristics

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Image /page/6/Picture/1 description: The image contains the words "UNITED IMAGING" in bold, sans-serif font. To the right of the words is a stylized logo. The logo is a dark blue color and appears to be a stylized letter U.

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Image /page/7/Picture/1 description: The image shows the logo for United Imaging. The text "UNITED IMAGING" is in bold, sans-serif font. To the right of the text is a stylized letter "U" that is split in the middle by a vertical white line. There is also a horizontal white line in the middle of the "U".

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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" 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 logo is a dark teal.

Note 4	Provides the smaller detector element number per row that induces less data sampling for CT imaging but provides sufficient data sampling for reconstruction which does not affect safety and effectiveness.
Note 5	The number of detector rows is determined by Z-plane coverage and size of detector element in Z-plane, which does not affect safety and effectiveness.
Note 6	With a reconstruction process, 40 slices or 80 slices can be achieved from the 40 rows detector. Provides the smaller slice number in one rotation induces longer scanning time for CT imaging, which does not affect safety and effectiveness.
Note 7	Minimum slice thickness is determined by size of detector element in Z-plane, which does not affect safety and effectiveness.
Note 8	Tube anode storage capacity is a kind of measurement about the maximum throughput of CT scanner. When an independent scan is implemented, the tube is heated and if the time interval between two independent scans is long enough, the heat can be dissipated timely but for short scan time interval, the heat which has not been dissipated timely should be stored within tube device and thus for the continuous scans (for short scan time intervals), higher storage capacity means that more continuous scan numbers can be supported. However, tube anode storage capacity has no effect on each independent scan.
Note 9	Maximum cooling rate is a kind of measurement about the maximum throughput of CT scanner. For the continuous scans, higher maximum cooling rate means that the tube heat can be dissipated faster and thus shorter scan time interval and more continuous scan numbers can be supported. However, it has no effect on each independent scan.
Note 10	Focus spot size has effect on image spatial resolution and smaller size is helpful for resolution improvement. However, the image spatial resolution between the two kinds of devices is equivalent substantially.
Note 11	Provides the smaller power output that induces lower ability of x-ray penetration when scanning the object with high BMI with higher possibility of photon starvation, and the safety has been evaluated by the related testing and verification.
Note 12	Provides the smaller mA output that induces lower ability of x-ray penetration when scanning the object with high BMI with higher possibility of photon starvation, and the safety has been evaluated by the related testing and verification.
Note 13	Provides slower rotation speed that induces longer scan time for examination which does not affect safety and effectiveness.
Note 14	With 120 kV and 5mm slice thickness, the image noise for typical head is 3HU on CTDIvol 28.9 mGy. The image noise level is equivalent substantially considering the proposed device has measured its noise based on the smaller CTDIvol than the Predicate Device.
Note 15	Provides the more slice thickness that induce more choice for various clinical scan situations and thinner slice thickness should bring higher
spatial resolution in z-plane, which does not affect safety and
effectiveness.

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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 letter "U" that is split into two parts by a horizontal line. The logo is simple and modern, and the color is a dark teal.

The proposed device and the predicate device are the same in regard to most of application features, except for cardiac.

Table 2 below provides a comparison of the application features of the proposed device in comparison to the predicate device.

| ITEM | Proposed Device
uCT 530, uCT 550 | Predicate Device
uCT 760, uCT 780 | Remark |
|---------------------------|-------------------------------------|--------------------------------------|--------|
| Application Features | | | |
| Iterative noise reduction | KARL 3D | KARL 3D | Same |
| Adaptive Filter | Adaptive Filter | Same | Same |
| Metal artifact reduction | MAC | MAC | Same |

Table 2 Comparison of Application Features

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 530/uCT 550 during the product development.

UNITED IMAGING HEALTHCARE claims conformance to the following standards and guidance:

Electrical Safety and Electromagnetic Compatibility (EMC)

Electrical Safety and Electromagnetic Compatibility (EMC) testing were conducted on the uCT 530/550 in accordance with the following standards:

A ES 60601-1:2005(R)2012+A1:2012+C1:2009/(R)2012+A2:2010/(R)2012 Medical electrical equipment Part 1: General requirements for basic safety and essential performance
A IEC 60601-2-44 Edition 3.0 2009, Medical Electrical Equipment - Part 2-44: Particular Requirements For The Basic Safety And Essential Performance Of Xray Equipment For Computed Tomography
A 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

NEMA XR 25-2010, Computed Tomography Dose Check A
A NEMA XR 28-2013, Supplemental Requirements For User Information And

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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: A General Requirements For Basic Safety And Essential Performance - Collateral Standard: Radiation Protection In Diagnostic X-ray Equipment
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

Performance Verification

A Clinical Evaluation for sample clinical images evaluation;
A AEC Test Report for AEC performance study.

Software

A NEMA PS 3.1-3.20(2011): Digital Imaging and Communications in Medicine (DICOM)
A 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 A
Code of Federal Regulations, Title 21, Subchapter J - Radiological Health
Laser Products - Conformance with IEC 60825-1 and IEC 60601-2-22; Guidance for Industry and FDA Staff (Laser Notice No. 50)
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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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.

Summarv

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.

9. Conclusions

Based on the comparison and analysis above, the proposed device has same intended use, similar performance, equivalence safety and effeteness 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.