The Supria True64 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 True64 is a multi-slice computed tomography system designed to perform multi-slice CT scanning supported by 64-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 True64 system uses 64-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 64 slices of data simultaneously. The X-ray 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 True64 system consists of a Gantry, Operator's Workstation, Patient Table, High-Frequency X-ray Generator, and accessories.

AI/ML Overview

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Important Note: This submission is a 510(k) premarket notification for a new version of an existing device (Supria True64 CT system). The primary goal of a 510(k) is to demonstrate substantial equivalence to a previously legally marketed device (predicate device), not necessarily to establish novel clinical efficacy or new performance benchmarks against a specific disease. Therefore, the "acceptance criteria" here are largely focused on maintaining equivalent performance to the predicate and adhering to relevant standards for CT systems. The studies are primarily to confirm this equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a numerical or target-based fashion for all parameters. Instead, it relies heavily on demonstrating that the Supria True64's performance is "similar to" or "comparable to" the predicate device (HITACHI SUPRIA Whole-body X-ray CT System Phase 3, K163528) and complies with relevant industry standards.

Here's a table summarizing the implicit acceptance criteria and reported performance, derived from the "Performance Comparison" and "Technological Characteristic Differences" sections:

Testing Type / Characteristic	Implicit Acceptance Criteria	Reported Device Performance (Supria True64)
Bench Validation Testing	No change / Substantial equivalence to predicate for specified parameters	"No change about the following performance: Dose Profile, Noise, Mean CT number and Uniformity, Spatial Resolution, Tomographic Section Thickness and Sensitivity Profile, Tomographic Plane Location, CT dose index."
Dose Profile	Equivalent to predicate	Equivalent to predicate (implied, as "no change")
Noise	Equivalent to predicate	Equivalent to predicate
Mean CT number & Uniformity	Equivalent to predicate	Equivalent to predicate
Spatial Resolution	Equivalent to predicate; 0.35 mm (high-contrast)	0.35 mm (high-contrast); Equivalent to predicate
Tomographic Section Thickness	Equivalent to predicate	Equivalent to predicate
Sensitivity Profile	Equivalent to predicate	Equivalent to predicate
Tomographic Plane Location	Equivalent to predicate	Equivalent to predicate
CT dose index	Equivalent to predicate	Equivalent to predicate
Low-contrast resolution	2.5 mm @ 0.25% at <4 rads (match predicate)	2.5 mm @ 0.25%
10% MTF	14.7 lp/cm (match predicate)	14.7 lp/cm
50% MTF	12.2 lp/cm (match predicate)	12.2 lp/cm
Clinical Validation Testing	Sufficient to judge clinical usability; low dose & high quality via IR	"3 kinds of clinical image example which we judged to be sufficient to judge a clinical usability." and "images... realized both low dose and high quality through reduction of image noise and artifacts" (via FBP and Iterative Reconstruction comparison).
Technological Characteristics	Maintain equivalence or minor differences that do not impact safety/effectiveness	Mostly "No" difference from the predicate, except for: - Detector: 64 rows added - Image Storage: Raw data disk for 64 slices added (larger capacity) - Helical Beam Pitch: Fine-tuned for 64 lines, new values provided
Standards Conformance	Compliance with specified IEC, AAMI, NEMA standards	Conforms to AAMI/ANSI ES60601-1, IEC 60601-1-2, IEC 60601-1-3, IEC 60601-2-44, NEMA XR 25, NEMA XR26, IEC 62304.

2. Sample Size Used for the Test Set and Data Provenance

Test Set Sample Size: The document does not specify a numerical sample size for the "clinical image examples." It only states "3 kinds of clinical image example."
Data Provenance: The document does not explicitly state the country of origin or if the data was retrospective or prospective. Given the context of a 510(k) submission for a new device model, it's highly likely these "image examples" were selected from internal company testing or possibly from clinical partners, but specifics are not provided.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

Number of Experts: Not specified.
Qualifications of Experts: Not specified. The document only states, "...which we judged to be sufficient to judge a clinical usability." This implies internal judgment, but no details on who made this judgment or their qualifications are given.

4. Adjudication Method for the Test Set

Adjudication Method: Not specified. The phrase "we judged to be sufficient" suggests an internal decision, but no formal adjudication process (like 2+1, 3+1 consensus) is outlined.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

MRMC Study: No, a formal MRMC comparative effectiveness study is not mentioned. The clinical evaluation focuses on qualitative judgment of "clinical usability" and a comparison of FBP vs. Iterative Reconstruction for image quality, not on human reader performance with or without AI assistance.

6. Standalone Performance Study (Algorithm Only)

Standalone Performance Study: Not explicitly. The device itself is an imaging system, not an AI algorithm performing a specific diagnostic task. The performance evaluation is for the imaging system's inherent capabilities (e.g., spatial resolution, noise, dose). The "Iterative Reconstruction" is an image processing algorithm, and its effect on image quality was evaluated, but not necessarily in a standalone study assessing its diagnostic accuracy independently.

7. Type of Ground Truth Used

Type of Ground Truth: For the "clinical image examples," the ground truth establishment method is not detailed beyond "we judged to be sufficient to judge a clinical usability." For the bench testing, the ground truth is based on physical phantom measurements and established engineering metrics for CT performance (e.g., measuring noise in a uniform phantom, spatial resolution using a line pair phantom).

8. Sample Size for the Training Set

Training Set Sample Size: Not applicable. This document describes a CT scanner (hardware and its integrated software for image acquisition and reconstruction), not a machine learning model that requires a "training set" in the conventional sense of AI/ML. The iterative reconstruction algorithms would have been developed and "trained" (in a broader sense of algorithm development and tuning) using various datasets, but these details are not provided in this 510(k) summary.

9. How the Ground Truth for the Training Set Was Established

Ground Truth for Training Set: Not applicable, as explained above. The development of the CT system's underlying physics models and reconstruction algorithms would rely on established scientific principles and engineering validation, rather than a "ground truth" derived from expert consensus on medical images that is typical for AI models.

Summary

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with flowing lines representing hair or movement.

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

August 18, 2017

Hitachi Healthcare Americas Corporation % Mr. Douglas J. Thistlethwaite Manager of Regulatory Affairs 1959 Summit Commerce Park TWINSBURG OH 44087

Re: K171738

Trade/Device Name: Supria True64 Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: July 26, 2017 Received: July 28, 2017

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 of medical device

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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.

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/ResourcesforYou/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,

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)

K171738

Device Name Supria True64 Form Approved: OMB No. 0910-0120

Expiration Date: January 31, 2017

See PRA Statement below.

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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510(k) Summary

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Submitter Information

Submitter:	Hitachi Healthcare Americas1959 Summit Commerce ParkTwinsburg, Ohio 44087-2371
Contact:	Douglas J. Thistlethwaite
Telephone number:	330-425-1313
Telephone number:	330-963-0749
E-mail:	thistlethwaited@hitachihealthcare.com
Date:	April 18, 2017

Subject Device Name

Trade/Proprietary Name:	Supria True64
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 Whole-body X-ray CT System Phase 3 (K163528)
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 True64 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

As part of our design validation performance comparison analysis was conducted to demonstrate continued conformance with a special control or recognized standard.

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

Testing Type	Rationale Analysis
Validation Testing - Bench	There is no change about the following performance.Dose Profile, Noise, Mean CT number and Uniformity, Spatial Resolution, Tomographic Section Thickness and SensitivityProfile, Tomographic Plane Location, CT dose indexTherefore, we judged that Supria is substantially equivalent to the predicate.
Validation Testing - Clinical	We provide 3 kinds of clinical image example which we judged to be sufficient to judge a clinical usability.

Table 1 Performance Comparison Analysis

The analysis confirms the performance characteristics of the Supria True64 are comparable to the predicate device and support our conclusion that the subject system is substantially equivalent.

Device Technological Characteristics

The technological characteristics of the Supria True64 and the predicate device are listed in Table 2.

ITEM	Supria True64	HITACHI Supria PHASE 3 (K163528)	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	Supria True64	HITACHI Supria PHASE 3 (K163528)	Difference
Detector
Type	Solid state	Solid state	No
Number of Channels	880 [ch] (16 slice)888 [ch] (64 slice)	880 [ch] (8ch reference)	No
Number of Rows	16 (16 slice)64 (64 slice)	16	See 01
Number of Slices	16 [slice/scan] (Axial) (16 slice)64 [slice/scan] (Axial) (64 slice)	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) (16 slice)800 [GB] (raw data) (64 slice)	110 [GB] (images),200 [GB] (raw data)	See 02
Storage Images	200,000	200,000	No
Archival Storage (Media)	DVD-R/RW, CD-R/RW	DVD-R/RW, CD-R/RW	No
ITEM	Supria True64	HITACHI Supria PHASE 3 (K163528)	Difference
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 (16 slice)0.58, 0.83, 1.08, 1.33, 1.58 (64 slice)	0.56, 0.81, 1.06, 1.31, 1.56	See 03
Collimation	1.25, 5, 10, 15, 20 [mm]	1.25, 5, 10, 15, 20 [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
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 spatial resolution	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
Iterative Reconstruction	Yes. Intelli IP Advanced, Intelli IP Quick	Yes. Intelli IP Advanced, Intelli IP Quick	No
Maximum possible pitch with fullimage quality	1.56 (16 slice)1.58 (64 slice)	1.56	See 03
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	Yes	Yes	No
ITEM	Supria True64	HITACHI Supria PHASE 3 (K163528)	Difference
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 Advanced, Intelli IP Quick	Yes. Intelli IP Advanced, Intelli IP Quick	No
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
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
HiMAR	Yes	Yes	No
Orbit synchronization scan	Yes	Yes	No
Off-time mode	Yes	Yes	No
On-time standby	Yes	Yes	No
Shutter Scan Reduction	Yes	Yes	No

Table 2 Technological Characteristic Differences

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The differences from the predicate device to Supria 64 are explained below table.

Detector
01	The 64 lines detector is added.
Image Storage
02	Raw data disk for 64 slices is added because the data amount for each raw data of 64 slices is .bigger than 16 slices.
Dose Controls
03	Helical Beam Pitch is fine-tuned for 64 lines.

Therefore, based on a thorough analysis and comparison of Supra 64 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 3.

ITEM	Overall Rationale Analysis
Gantry	There are no significant changes in technology characteristics, hardware, and software from the predicate device, HITACHI Supria PHASE 3 (K163528).
Detector
X-ray Tube
X-ray Generator
Patient Table
Display
Image Storage
Scanning,Reconstruction
Performance
Dose Controls
Dose Displays
Features

Table 3 Rationale Analysis: Supria vs. Predicate

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 True64 Whole-body X-ray CT System is considered substantially equivalent to the currently marketed predicate device (SUPRIA Whole-body X-ray CT System (K163528)) in terms of design features, fundamental scientific technology, indications for use, and safety and effectiveness.

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Summary of Non-Clinical Testing

This 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.

Noise, Mean CT number, Uniformity and Spatial Resolution test results for the Supria True64 were compared to results from the Supria PHASE 3 (K163528. Our findings determined the systems to be equivalent. The summary report on these findings is provided in this submission.

In addition, the Supria True64 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 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 cvcle processes .

Summary of Clinical Testing

As part of design validation, Hitachi has provided 3 kinds of clinical image examples which we judged to be sufficient to judge a clinical usability.

In addition, a comparative evaluation was conducted of via FBP and Iterative Reconstruction. It resulted in finding the images from the Supria True64 realized both low dose and high quality through reduction of image noise and artifacts.

Conclusions

Hitachi believes that, based on the information included in the submission, Supria True64 Whole-body X-ray CT System is substantially equivalent with respect to hardware, base elements of the software, safety, effectiveness, and functionality to the SUPRIA Whole-body Xray System Phase 3 (K163528).

Regulation Number and Section

N/A