The Supria system is indicated for head, whole body, and vascular X-ray Computed Tomography applications in patients of all ages. The images can be acquired in either axial, helical, or dynamic modes.

The volume datasets acquired by the Supria can be post processed by the system to provide additional information. Post processing capabilities included in the Supria software include CT angiography (CTA), Multi-planar reconstruction (MPR) and volume rendering.

Volume datasets acquired by the Supria can be transferred to external devices via a DICOM standard interface.

The guideShot Option adds a remote in-room display and controls to support interventional imaging. The device output can provide an aid to diagnosis when used by a qualified physician.

Device Description

The Supria is a multi-slice computed tomography system designed to perform multi-slice CT scanning supported by 16-detector technology. The system allows optimum clinical applications ranging from routine exams in response to the diversified circumstances in imaging whole body regions.

The Supria system uses 16-slice CT technology, where the X-ray tube and detector assemblies are mounted on a frame that rotates continuously around the patient using slip ring technology. The solid-state detector assembly design collects up to 16 slices of data simultaneously. The Xray sub-system features a high frequency generator. X-ray tube, and collimation system that produces a fan beam X-ray output. The system can operate in a helical (spiral) scan mode where the patient table moves during scanning. As the X-ray tube/detector assembly rotates around the patient, data is collected at multiple angles.

The collected data is then reconstructed into cross-sectional images by a high-speed reconstruction sub-system. The images are displayed on a Computer Workstation, stored, printed, and archived as required. The workstation is based on current PC technology using the Windows™ operating system.

The Supria system consists of a Gantry, Operator's Workstation, Patient Table, High-Frequency X-ray Generator, and accessories.

AI/ML Overview

The provided text is a 510(k) Pre-market Notification for a medical device, specifically the HITACHI Supria Whole-body X-ray CT System Phase 3. It compares the new device to a predicate device (HITACHI SUPRIA w/guideShot Option K161748) to demonstrate substantial equivalence, rather than providing a detailed study proving the device meets acceptance criteria in the sense of a performance study with specific metrics and statistical analysis.

The document states that the new device has two new features: "Intelli IP Quick" (a faster noise reduction technique) and "HiMAR" (reduces artifacts caused by metal). The "Performance Testing - Clinical" section briefly mentions that "clinical images were collected and analyzed" for these new features to "ensure that images constructed by the Supria Whole-body X-ray CT System meet user needs." It also notes that "Hitachi has provided clinical images demonstrating the image quality of Intelli IP Quick and HiMAR features and validated by a physician."

Therefore, it is important to note that the provided text does NOT contain the detailed information typically found in a clinical study report that defines and proves specific acceptance criteria for performance metrics (like sensitivity, specificity, accuracy) using a rigorous methodology. Instead, it relies on demonstrating comparable performance to a predicate device and physician validation of image quality for new features.

Based on the provided text, here's what can be extracted and what remains unknown:

Acceptance Criteria and Device Performance (Based on provided text)

Since direct quantitative acceptance criteria and performance metrics are not explicitly stated in a table format for the new features or overall device, we can infer the "acceptance" is primarily based on substantial equivalence to the predicate device and subjective physician validation of image quality for the new features.

Acceptance Criterion (Inferred from 510(k) context)	Reported Device Performance (From text)
Overall substantial equivalence to predicate device (SUPRIA w/guideShot Option K161748) in terms of:	"The analysis confirms the performance characteristics of the Supria Whole-body X-ray CT System Phase 3 are comparable to the predicate device and support our conclusion that the Phase 3 system is substantially equivalent." "Hitachi believes that, based on the information included in the submission, Supria Whole-body X-ray CT System Phase 3 is substantially equivalent with respect to hardware, base elements of the software, safety, effectiveness, and functionality to the SUPRIA w/guideShot Option (K161748)."
- Hardware	No differences identified (e.g., Gantry, Detector, X-ray Tube, X-ray Generator, Patient Table, Display, Image Storage parameters are identical to predicate).
- Base elements of software	Most software features are identical to the predicate. Key differences (Intelli IP Quick, HiMAR, Orbit synchronization scan, Off-time mode, On-time standby, Shutter Scan Reduction) are described as improvements or additional functionalities.
- Safety	"The technological characteristics do not impact safety and effectiveness." (Stated for the differences in Table 3). Compliance with applicable safety standards (e.g., IEC 60601 series, NEMA XR 25, NEMA XR26) is declared.
- Effectiveness	"The technological characteristics do not impact safety and effectiveness." (Stated for the differences in Table 3). Clinical images demonstrating the image quality of Intelli IP Quick and HiMAR features were "collected and analyzed" and "validated by a physician" to "ensure that images constructed by the Supria Whole-body X-ray CT System meet user needs." The overall "Performance Comparison" section also states "A clinical evaluation comparison was conducted with the Supria Phase 3 system and the SUPRIA w/guideShot Option (K161748) and found to be substantially equivalent."
- Functionality	Detailed comparison in Table 2 shows identical functionality for many parameters, with new features (Intelli IP Quick, HiMAR etc.) presented as enhancements that do not negatively impact core functionality.
Image Quality with new features (Intelli IP Quick, HiMAR)	"clinical images demonstrating the image quality of Intelli IP Quick and HiMAR features and validated by a physician." The images were collected and analyzed "to ensure that images constructed by the Supria Whole-body X-ray CT System meet user needs."

Study Details:

Sample sizes used for the test set and data provenance:
- Test Set Sample Size: Not specified. The document only mentions that "clinical images were collected and analyzed" for the new features. No specific number of images or patients is provided.
- Data Provenance: Not specified regarding country of origin. The study is described as "clinical images were collected," implying real patient data. It is a retrospective or prospective study is not specified, but the phrasing "were collected" could suggest a collection from existing or newly acquired cases.
Number of experts used to establish the ground truth for the test set and their qualifications:
- Number of Experts: Not specified. The document states the image quality was "validated by a physician." It does not specify if this was one physician or a panel.
- Qualifications of Experts: The qualification is generally stated as "a physician." Specific specialties (e.g., Radiologist) or years of experience are not mentioned.
Adjudication method for the test set:
- Not specified. Given the limited detail ("validated by a physician"), it's unlikely a formal adjudication method (like 2+1 or 3+1) was employed and documented in this 510(k) submission.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
- Not explicitly stated or described. The document refers to a "clinical evaluation comparison" but does not detail it as a formal MRMC study. It states the comparison "found to be substantially equivalent" and that clinical images were "validated by a physician." There is no mention of multiple human readers, a comparative effectiveness study design, or an effect size for human readers' improvement with AI assistance. The new features (Intelli IP Quick, HiMAR) are signal processing techniques within the CT system, not an AI assistance tool for human interpretation in the sense of a CAD system.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- The "performance comparison" section mentions "Performance Testing - Bench" with a rationale analysis indicating "Hitachi judged that Supria Whole-body X-ray CT System Phase 3 is substantially equivalent to the predicate." It also notes that the device complies with "all applicable requirements for Dose Profile, Noise, Mean CT number and Uniformity, Spatial Resolution, Tomographic Section Thickness and Sensitivity Profile, Tomographic Plane Location, and CT dose index." This sounds like standalone technical performance testing, but not necessarily a clinical "algorithm only" performance evaluation akin to an AI diagnostic tool. The device itself is a CT scanner, not an AI algorithm intended for standalone diagnosis.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the clinical evaluation of the new features (Intelli IP Quick, HiMAR), the ground truth appears to be based on "physician validation" of "image quality" and ensuring that the images "meet user needs." This is a subjective assessment, not pathology or outcomes data. For the comparison to the predicate, it's about comparable physical and performance characteristics.
The sample size for the training set:
- Not applicable / Not specified. The document describes a CT system and its new image processing features. It does not mention a "training set" in the context of machine learning. The "Intelli IP Quick" and "HiMAR" are described as "processing techniques" that reduce noise or reduce metal artifacts, implying algorithms that might have been developed and tuned, but the text does not detail any "training data" or "training set" as would be seen for a deep learning model.
How the ground truth for the training set was established:
- Not applicable / Not specified. As no training set or machine learning model is explicitly described, there is no information on how a ground truth for such a set would have been established.

Summary

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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the edge. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines extending from the heads.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 3, 2017

Hitachi Medical Systems America, Inc. % Mr. Doug Thistlethwaite Manager of Regulatory Affairs 1959 Summit Commerce Park TWINSBURG OH 44087

Re: K163528

Trade/Device Name: HITACHI Supria Whole-body X-rav CT System Phase 3 Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: December 9, 2016 Received: December 16, 2016

Dear Mr. Thistlethwaite:

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. 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Michael D'Hara

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

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Indications for Use

510(k) Number (if known)

K163528

Device Name

HITACHI Supria Whole-body X-ray CT System Phase 3

Indications for Use (Describe)

Volume datasets acquired by the Supria can be transferred to external devices via a DICOM standard interface. The guideShot Option adds a remote in-room display and controls to support interventional imaging. The device output can provide an aid to diagnosis when used by a qualified physician.

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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Section 5

510(k) Summary

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Submitter:	Hitachi Medical Systems America, Inc.1959 Summit Commerce ParkTwinsburg, Ohio 44087-2371
Contact:	Douglas J. Thistlethwaite
Telephone number:	330-425-1313
Telephone number:	330-963-0749
E-mail:	thistlethwaited@hitachimed.com
Date:	November 1, 2016

Submitter Information

Subject Device Name

Trade/Proprietary Name:	HITACHI Supria Whole-body X-ray CT System Phase 3
Regulation Number:	21 CFR 892.1750
Regulation Name:	Computed tomography x-ray system
Product Code	JAK, System, X-Ray, Tomography, Computed
Class	II
Panel	Radiology

Predicate Device Name

Predicate Device(s):	HITACHI SUPRIA w/guideShot Option (K161748)
Regulation Number:	21 CFR 892.1750
Regulation Name:	Computed tomography x-ray system
Product Code	JAK, System, X-Ray, Tomography, Computed
Class	II
Panel	Radiology

Device Intended Use

Volume datasets acquired by the Supria can be transferred to external devices via a DICOM standard interface.

The guideShot Option adds a remote in-room display and controls to support interventional imaging. The device output can provide an aid to diagnosis when used by a qualified physician.

Device Description

Function

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Scientific Concepts

Physical and Performance Characteristics

The Supria system consists of a Gantry, Operator's Workstation, Patient Table, High-Frequency X-ray Generator, and accessories. The system performance is similar to the predicate device.

Performance Comparison

A clinical evaluation comparison was conducted with the Supria Phase 3 system and the SUPRIA w/guideShot Option (K161748) and found to be substantially equivalent.

There is no change in the performance of the system in regards to Dose Profile, Noise, Mean CT number and Uniformity, Spatial Resolution, Tomographic Section Thickness and Sensitivity Profile, Tomographic Plane Location, and CT dose index.

A rationale analysis was then conducted and the results are contained in Table 1.

Table 1 Performance Comparison Analysis
Testing Type	Rationale Analysis
Performance Testing - Bench	Hitachi judged that Supria Whole-body X-ray CT System Phase 3is substantially equivalent to the predicate.
Performance Testing - Clinical	Hitachi has provided clinical images demonstrating the image quality of Intelli IP Quick and HiMAR features and validated by a physician.

The analysis confirms the performance characteristics of the Supria Whole-body X-rav CT System Phase 3 are comparable to the predicate device and support our conclusion that the Phase 3 system is substantially equivalent.

Device Technological Characteristics

The technological characteristics of the Supria and the predicate device are listed in Table 2.

Table 2 Technological Characteristic Differences0
-------------------------------------------------------

ITEM	HITACHI Supria Whole-body X-rayCT System Phase 3	HITACHI SUPRIA w/guideShotOption (K161748)	Difference
Gantry
Geometry	Rotate-rotate with offset detector system, slip ring	Rotate-rotate with offset detector system, slip ring	No
Scan Time	0.75, 1.0, 1.5, 2.0 [s]	0.75, 1.0, 1.5, 2.0 [s]	No
X-ray Fan Beam Angle	51 [deg]	51 [deg]	No
Gantry Tilt	-30 to +30 [deg]	-30 to +30 [deg]	No
Gantry Aperture	750 [mm]	750 [mm]	No
Gantry Dimensions	1990 x 920 x 1842.5 [mm]	1990 x 920 x 1842.5 [mm]	No
Gantry Weight	1600 [kg]	1600 [kg]	No
Scan Localizer	Laser	Laser	No
ITEM	HITACHI Supria Whole-body X-rayCT System Phase 3	HITACHI SUPRIA w/guideShotOption (K161748)	Difference
Detector
Type	Solid state	Solid state	No
Number of Channels	880 [ch] (8ch reference)	880 [ch] (8ch reference)	No
Number of Rows	16	16	No
Number of Slices	16 [slice/scan] (Axial)	16 [slice/scan] (Axial)	No
X-ray Tube
Anode Heat Storage	5 [MHU]	5 [MHU]	No
Dissipation Rate	470 [kHU/min]	470 [kHU/min]	No
Tube cooling	Oil/air	Oil/air	No
Tube focal spot	Dual 0.7 x 0.8, 1.2 x 1.4 [mm]	Dual 0.7 x 0.8, 1.2 x 1.4 [mm]	No
X-ray Generator
kW Output	System Maximum 48[kW] /Generator Maximum 51 [kW]	System Maximum 48[kW] /Generator Maximum 51 [kW]	No
Max. Power Input	75 [kVA]	75 [kVA]	No
kVp Range	80, 100, 120, 140 [kVp]	80, 100, 120, 140 [kVp]	No
mA Range	10 to 400 [mA] @120kV, 48kW	10 to 400 [mA] @120kV, 48kW	No
Patient Table
Range of Movement,Vertical	450 to 1000 [mm] (CT-WT-21)	450 to 1000 [mm] (CT-WT-21)	No
Range of Movement,Longitudinal	1910 [mm] (CT-WT-21)	1910 [mm] (CT-WT-21)	No
Range of Movement,Lateral	N/A	N/A	No
Scannable Range	155 cm	155 cm	No
Maximum Load Capacity	227 [kg]	227 [kg]	No
Display
Monitor Type	24" LCD	24" LCD	No
Matrices, Pixels	1920 x 1200	1920 x 1200	No
Image Enlargements	Up to 9.99x	Up to 9.99x	No
Max. Slices Displayed at Once	25	25	No
Image Storage
Hard Disk	110 [GB] (images),200 [GB] (raw data)	110 [GB] (images),200 [GB] (raw data)	No
Storage Images	200,000	200,000	No
Archival Storage (Media)	DVD-R/RW, CD-R/RW	DVD-R/RW, CD-R/RW	No
Scanning, Reconstruction
Localization Scan	Real time	Real time	No
Localization Scan Length	150, 250, 350, 500, 750,1000, 1250, 1500, 1750 [mm]	150, 250, 350, 500, 750,1000, 1250, 1500, 1750 [mm]	No
Max. Scan Time	100 [s]	100 [s]	No
Helical Beam Pitch	0.56, 0.81, 1.06, 1.31, 1.56	0.56, 0.81, 1.06, 1.31, 1.56	No
Collimation	1.25, 5, 10 [mm]	1.25, 5, 10 [mm]	No
Reconstruction Matrix	512 x 512 [pix]	512 x 512 [pix]	No
Reconstruction FOVs	20 to 500 [mm]	20 to 500 [mm]	No
Slice Thickness	0.625, 1.0, 1.25, 2.5, 3.75,5.0, 7.5, 10.0 [mm]	0.625, 1.0, 1.25, 2.5, 3.75,5.0, 7.5, 10.0 [mm]	No
ITEM	HITACHI Supria Whole-body X-rayCT System Phase 3	HITACHI SUPRIA w/guideShotOption (K161748)	Difference
Range of CT numbers	-2000 to +4000 (13bit)-32768 to +32767 (16bit)	-2000 to +4000 (13bit)-32768 to +32767 (16bit)	No
Reconstruction Time	0.1 seconds per image or less	0.1 seconds per image or less	No
Performance
High-contrast spatialresolution	0.35 [mm]	0.35 [mm]	No
Low-contrast resolution mm at% at ≤4 rads	2.5 [mm] @ 0.25%	2.5 [mm] @ 0.25%	No
10% MTF	14.7 [lp/cm]	14.7 [lp/cm]	No
50% MTF	12.2 [lp/cm]	12.2 [lp/cm]	No
Dose Controls
Bow Tie Filter	Yes. Normal	Yes. Normal	No
Automatic Exposure Control	Yes. IntelliEC	Yes. IntelliEC	No
Longitudinal Modulation	Yes	Yes	No
Angular Modulation	Yes	Yes	No
Maximum possible pitch withfull image quality	1.56	1.56	No
Dose Displays
CTDIv	Yes	Yes	No
DLP	Yes	Yes	No
Features
Axial Scan	Yes	Yes	No
Helical Scan	Yes	Yes	No
Dynamic Scan	Yes	Yes	No
Predict Scan	Yes	Yes	No
ECG Retrospective Scan(Helical)	No	No	No
ECG Prospective Scan(Axial)	No	No	No
guideShot Scan (option)	Yes	Yes	No
Automatic Exposure Control	Yes	Yes	No
Automatic Exposure Controlusing Iterative Reconstruction	No	No	No
ECG Dose Modulation	No	No	No
Adaptive Filter	No	No	No
Iterative Reconstruction	Yes. Intelli IP Quick	Yes. Intelli IP Advanced	See 01
Injector Synchronization	Yes	Yes	No
Dose Check	Yes	Yes	No
Access Control	Yes	Yes	No
Automatic Cardiac PhaseSearch	No	No	No
Preview Scan	No	No	No
Double Slice at Axial Scan	No	No	No
Priority Recon.	No	No	No
Dose Report	Yes. Simple Dose Report	Yes. Simple Dose Report	No
DICOM	Yes	Yes	No
ID Reader	Yes	Yes	No
ITEM	HITACHI Supria Whole-body X-rayCT System Phase 3	HITACHI SUPRIA w/guideShotOption (K161748)	Difference
Exam Split	Yes	Yes	No
Multi-Planar Reconstruction(MPR)	Yes	Yes	No
Volume Rendering	Yes	Yes	No
CT Angiography (CTA)	Yes	Yes	No
Segmentation	Yes	Yes	No
Retouch	Yes	Yes	No
Quality Exam	Yes	Yes	No
Iterative Reconstruction	Yes. Intelli IP Quick	Yes. Intelli IP Advanced	See 01
HiMAR	Yes	No	See 02
Orbit synchronization scan	Yes	No	See 03
Off-time mode	Yes	No	See 04
On-time standby	Yes	No	See 05
Shutter Scan Reduction	Yes	No	See 06

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The differences from the predicate device to Supria Whole-body X-ray CT System Phase 3 are explained in Table 3.

Table 3 Analysis of Differences

Features
01	Intelli IP Quick: Intelli IP Quick is a faster noise reduction processing technique as compared to Intelli IP.
02	HIMAR: HIMAR reduces lack of photon caused by X-ray going through a highly absorptive body such as metals and ametal artifact caused by beam hardening.
03	Orbit synchronization scan: By using the orbit synchronization, the orbit of the volume scan multiple sequences canbe combined and differences can be easily extracted by comparing each image together.
04	Off-time mode: The power consumption of the detector system is saved and noise is reduced when the power of theCT system is off. According to the usage of the system, the starting time can be registered.
05	On-time standby: During operation of the CT system, The power consumption under the standby condition is savedand noise is reduced.
06	Shutter Scan Reduction: The number of shutter scans was reduced.

Therefore, based on a thorough analysis and comparison of the Supria Whole-body X-ray CT System Phase 3 and the predicate device, the technological characteristics do not impact safety and effectiveness.

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Substantial Equivalence

A summary decision was based on analysis of Table 4.

Table 4 Rationale Analysis: Supria vs. Predicate
--------------------------------------------------	--	--

ITEM	Overall Rationale Analysis
Gantry	Based on that there are no significant differences from the predicate device,
Detector	Hitachi judges that the Supria Whole-body X-ray CT System Phase 3 device
X-ray Tube	has no additional issues with safety and effectiveness.
X-ray Generator
Patient Table
Display
Image Storage
Scanning,
Reconstruction
Performance
Dose Controls
Dose Displays
Features	Based on results of design inspection as confirmed in the Declaration ofConformity, Hitachi judges that the Supria Whole-body X-ray CT System Phase3 device has no additional issues with safety and effectiveness.

Therefore, based on a thorough analysis and comparison of the functions, scientific concepts, physical and performance characteristics, performance comparison and technological characteristics, the proposed Supria Whole-body X-ray CT System Phase 3 is considered substantially equivalent to the currently marketed predicate device (SUPRIA w/guideShot Option (K161748)) in terms of design features, fundamental scientific technology, indications for use, and safety and effectiveness.

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Summary of Non-Clinical Testing

The Supria system is in conformance with the applicable parts of the following standards:

AAMI ANSI ES60601-1:2005/(R) 2012 and A1:2012, C1:2009/(R)2012 and ● A2:2010/(R)2012
Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD)
IEC 60601-1-2 Edition 3: 2007 . Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests
IEC 60601-1-3 Edition 2.0 2008-01 .

Medical electrical equipment - Part 1-3: General requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment

IEC 60601-2-44 Edition 3.0 2009-02 o Medical electrical equipment Part 2-44: particular requirements for the basic safety and essential performance of x-ray equipment for computed tomography.
NEMA XR 25 Computed Tomography Dose Check
. NEMA XR26

Access Controls for Computer Tomography: Identification, Interlocks, and Logs

IEC 62304 First edition 2006-05, Medical device software Software life cycle processes 0
In addition, the device complies with all applicable requirements for Dose Profile, Noise, Mean CT number and Uniformity, Spatial Resolution, Tomographic Section Thickness and Sensitivity Profile, Tomographic Plane Location, and CT dose index.

Summary of Clinical Testing

Using the 2 new features, clinical images were collected and analyzed, to ensure that images constructed by the Supria Whole-body X-ray CT System meet user needs.

As a result of the analysis:

Testing Type	Rationale Analysis
Performance Testing - Clinical	Hitachi has provided clinical images demonstrating the image quality of Intelli IP Quick and HiMAR features and validated by a physician.

Conclusions

Hitachi believes that, based on the information included in the submission, Supria Whole-body X-ray CT System Phase 3 is substantially equivalent with respect to hardware, base elements of the software, safety, effectiveness, and functionality to the SUPRIA w/quideShot Option (K161748).

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.