SCENARIA Phase 3 Whole-body X-ray CT System

K150595 · Hitachi Medical Systems America, Inc. · JAK · Oct 30, 2015 · Radiology

Device Facts

• Record ID: K150595
• Device Name: SCENARIA Phase 3 Whole-body X-ray CT System
• Applicant: Hitachi Medical Systems America, Inc.
• Product Code: JAK · Radiology
• Decision Date: Oct 30, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1750
• Device Class: Class 2

Intended Use

The SCENARIA Phase 3 system is indicated for head, whole body, cardiac and vascular X-ray Computed Tomography applications in patients of all ages. The images can be acquired in either axial, helical, gated or dynamic modes. The volume datasets acquired by the SCENARIA Phase 3 can be post processed by the SCENARIA Phase 3 to provide additional information. Post processing capabilities included in the SCENARIA Phase 3 software include CT angiography (CTA), Multi-planar reconstruction (MPR) and volume rendering. Volume datasets acquired by the SCENARIA Phase 3 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 Story

Multi-slice CT system; uses X-ray tube/detector assembly rotating on gantry via slip rings to collect 64-slice data simultaneously; produces cross-sectional images. Operates in axial, helical, gated, or dynamic modes. High-speed reconstruction sub-system processes data into images for display on PC-based workstation. Includes post-processing (CTA, MPR, volume rendering). guideShot option provides remote in-room display/controls for interventional imaging. Used in clinical settings by qualified physicians to aid diagnosis. Features include automatic exposure control (IntelliEC/IntelliEC Plus), iterative reconstruction (Intelli IP), and ECG-gated dose modulation. Output affects clinical decision-making by providing diagnostic-quality anatomical images.

Clinical Evidence

No formal clinical trial; clinical usability demonstrated via five clinical image examples covering general anatomy. Images judged comparable to predicate device anatomy examples.

Technological Characteristics

128-slice CT technology; 750mm gantry aperture; 72kW generator; solid-state detector (64 rows, 888 channels). PC-based workstation (Windows OS). Connectivity via DICOM. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-3, IEC 60601-2-44, NEMA XR-25, NEMA XR-26, IEC 62304.

Indications for Use

Indicated for head, whole body, cardiac, and vascular X-ray CT imaging in patients of all ages. No specific contraindications listed.

Regulatory Classification

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.

Predicate Devices

• SCENARIA Phase 2 Whole-body X-ray CT System (K123509)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with the profiles overlapping and connected by flowing lines.

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

October 30, 2015

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

## Re: K150595

Trade/Device Name: HITACHI SCENARIA Phase 3 Whole-body X-ray CT System Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: October 2, 2015 Received: October 6, 2015

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.

{1}------------------------------------------------

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 [phone] or [phone] 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 [phone] or [phone] or at its Internet address

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

Sincerely yours,

Robert Oaks

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}------------------------------------------------

#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

### Indications for Use

510(k) Number (if known) K150595

Device Name

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

#### Indications for Use (Describe)

The SCENARIA Phase 3 system is indicated for head, whole body, cardiac and vascular X-ray Computed Tomography applications in patients of all ages. The images can be acquired in either axial, helical, gated or dynamic modes.

The volume datasets acquired by the SCENARIA Phase 3 can be post processed by the SCENARIA Phase 3 to provide additional information. Post processing capabilities included in the SCENARIA Phase 3 software include CT angiography (CTA), Multi-planar reconstruction (MPR) and volume rendering.

Volume datasets acquired by the SCENARIA Phase 3 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)

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

{3}------------------------------------------------

Section 5

510(k) Summary

{4}------------------------------------------------

| Submitter: | Hitachi Medical Systems America, Inc.<br>1959 Summit Commerce Park<br>Twinsburg, Ohio 44087-2371 |
|-------------------|--------------------------------------------------------------------------------------------------|
| Contact: | Douglas J. Thistlethwaite |
| Telephone number: | 330-425-1313 |
| Telephone number: | 330-963-0749 |
| E-mail: | [e-mail] |
| Date: | February 26, 2015 |

## Submitter Information

## Device Name

| 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 |
| Trade/Proprietary Name: | SCENARIA Phase 3 Whole-body X-ray CT System |
| Predicate Device(s): | SCENARIA Phase 2 Whole-body X-ray CT System (K123509) |

# Device Intended Use

The SCENARIA Phase 3 system is indicated for head, whole body, cardiac and vascular X-ray Computed Tomography applications in patients of all ages. The images can be acquired in either axial, helical, gated or dynamic modes,

The volume datasets acquired by the SCENARIA Phase 3 can be post processed by the SCENARIA Phase 3 to provide additional information. Post processing capabilities included in the SCENARIA Phase 3 software include CT angiography (CTA), Multi-planar reconstruction (MPR) and volume rendering.

Volume datasets acquired by the SCENARIA Phase 3 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

The SCENARIA Phase 3 is a multi-slice computed tomography system that uses x-ray data to produce cross-sectional images of the body at various angles.

## Scientific Concepts

The SCENARIA Phase 3 system uses 128-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.

{5}------------------------------------------------

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.

## Physical and Performance Characteristics

The SCENARIA Phase 3 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

Evaluations were conducted for dose profile, image noise, Modulation Transfer Function (MTF), slice thickness and sensitivity profile, slice plane location, and CT dose index and also found to be substantially equivalent.

A clinical evaluation comparison was conducted with the SCENARIA Phase 3 system and the SCENARIA Phase 2 System (K123509) and found to be substantially equivalent.

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

| Testing Type | Rationale Analysis |
|--------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Performance Testing - Bench | We generated bench data based on IEC61223-3-5.<br>We confirmed that the items (Dose Profile, Noise, Mean CT number and Uniformity, Sparial Resolution, Tomographic Section Thickness and Sensitivity Profile, Tomographic Plane Location, CT dose index) which we tested met the conditions of 21 CFR 1020.33(c) or (g).<br>This shows that SCENARIA Phase3 has equivalent basic performance as the predicate device, SCENARIA Phase2. |
| Performance Testing - Clinical | We provide five clinical image examples which we judged to be sufficient to judge a clinical usability. The five covered the general anatomy outlined in the indications for use and are comparable to the anatomy examples provided for the predicate. |

#### Table 1 Performance Comparison Analysis

The analysis confirms the performance characteristics of the SCENARIA Phase 3 system are comparable to the predicate device and support our conclusion that the SCENARIA Phase 3 system is substantially equivalent.

# Device Technological Characteristics

The technological characteristics of the SCENARIA Phase 3 and the predicate device are listed in Table 2.

| ITEM | HITACHI SCENARIA PHASE 3 | HITACHI SCENARIA PHASE 2 (K123509) | Difference Analysis |
|------------------------------------------------------------------------------------|---------------------------------------------------------|---------------------------------------------------------|---------------------|
| Gantry | | | |
| Geometry | Rotate-rotate with offset detector system,<br>slip ring | Rotate-rotate with offset detector system,<br>slip ring | No |
| Scan Time | 0.35, 0.4, 0.5, 0.75, 1.0, 2.0 [s] | 0.35, 0.4, 0.5, 0.75, 1.0, 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 | 2350 x 880 x 2030 [mm] | 2350 x 880 x 2030 [mm] | No |
| Gantry Weight | 2235 [kg] | 2235 [kg] | No |
| Scan Localizer | Laser | Laser | No |
| ITEM | HITACHI SCENARIA PHASE 3 | HITACHI SCENARIA PHASE 2 (K123509) | Difference Analysis |
| Detector | | | |
| Type | Solid state | Solid state | No |
| Number of Channels | 888 [ch] (8ch reference) | 888 [ch] (8ch reference) | No |
| Number of Rows | 64 | 64 | No |
| Number of Slices | 64, 128 [slice/scan] (Axial) | 64, 128 [slice/scan] (Axial) | No |
| X-ray Tube | | | |
| Anode Heat Storage | 7.5 [MHU] | 7.5 [MHU] | No |
| Dissipation Rate | 1,386 [kHU/min] | 1,386 [kHU/min] | No |
| Tube cooling | Cooling Fluid/air | Cooling Fluid/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 | 72 [kW] | 72 [kW] | No |
| Max. Power Input | 100 [kVA] | 100 [kVA] | No |
| kVp Range | 80, 100, 120, 140 [kVp] | 80, 100, 120, 140 [kVp] | No |
| mA Range | 10 to 600 [mA] @120kV, 72kW | 10 to 600 [mA] @120kV, 72kW | No |
| Patient Table | | | |
| Range of Movement, Vertical | 465 to 1050 [mm] (CT-WT-19) | 465 to 1050 [mm] (CT-WT-19) | No |
| Range of Movement, Longitudinal | 2110 [mm] | 2110 [mm] | No |
| Range of Movement, Lateral | -80 to +80 [mm] (CT-WT-19) | -80 to +80 [mm] (CT-WT-19) | No |
| Scannable Range | 175 cm | 175 cm | No |
| Maximum Load Capacity | 230 [kg] | 230 [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 | 250 [GB] (images), | 250 [GB] (images), | No |
| | 750 [GB] (raw data) | 750 [GB] (raw data) | |
| Storage Images | 200,000 | 200,000 | No |
| Archival Storage (Media) | DVD-RAM, DVD-R/RW, | DVD-RAM, DVD-R/RW, | No |
| | CD-R/RW | CD-R/RW | |
| Scanning, Reconstruction | | | |
| Localization Scan | Real time | Real time | No |
| Localization Scan Length | 150, 250, 350, 500, 750, | 150, 250, 350, 500, 750, | No |
| | 1000, 1250, 1500, 1750 [mm] | 1000, 1250, 1500, 1750 [mm] | |
| Max. Scan Time | 100 [s] | 100 [s] | No |
| Helical Beam Pitch | 0.58, 0.83, 1.08, 1.33, 1.58 | 0.58, 0.83, 1.08, 1.33, 1.58 | No |
| | @40mm Collimation | @40mm Collimation | |
| Collimation | 1.25, 5, 10, 15, 20, 40 [mm] | 1.25, 5, 10, 15, 20, 40 [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,<br>5.0, 7.5, 10.0 [mm] | 0.625, 1.0, 1.25, 2.5, 3.75,<br>5.0, 7.5, 10.0 [mm] | No |
| Range of CT numbers | -2000 to +4000 (13bit) | -2000 to +4000 (13bit) | No |
| | -32768 to +32767 (16bit) | -32768 to +32767 (16bit) | |
| Reconstruction Time | 0.056 seconds per image or less | 0.056 seconds per image or less | See 01 |
| Performance | | | |
| High-contrast spatial resolution | 0.35 [mm] | 0.35 [mm] | No |
| Low-contrast resolution mm at % | 2.5 [mm] @ 0.25% | 2.5 [mm] @ 0.25% | No |
| at <4 rads | | | |
| 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. Small / Normal | Yes. Small / Normal | No |
| Automatic Exposure Control | Yes. IntelliEC, IntelliEC Plus | Yes. IntelliEC | See 02 |
| | | | |
| ITEM | HITACHI SCENARIA PHASE 3 | HITACHI SCENARIA PHASE 2 (K123509) | Difference Analysis |
| Longitudinal Modulation | Yes | Yes | No |
| Angular Modulation | Yes | Yes | No |
| Iterative Reconstruction | Yes. Intelli IP Advanced Mode. | Yes. Intelli IP Advanced Mode | No |
| Maximum possible pitch with full<br>image quality | 1.58 | 1.58 | 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<br>(Helical) | Yes | Yes | No |
| ECG Prospective Scan<br>(Axial) | Yes | Yes | No |
| guideShot Scan | Yes | Yes | No |
| Automatic Exposure Control | Yes. IntelliEC | Yes. IntelliEC | No |
| Automatic Exposure Control<br>considering the level of Iterative<br>Reconstruction | Yes. IntelliEC Plus | No. | See 03 |
| ECG Dose Modulation | Yes. IntelliEC Cardiac | No. | See 04 |
| Adaptive Filter | Yes. Intelli IP Normal | Yes. Intelli IP Normal | No |
| Iterative Reconstruction | Yes. Intelli IP Advanced | Yes. Intelli IP Advanced | No |
| Injector Synchronization | Yes | Yes | No |
| Dose Check | Yes | Yes | No |
| Access Control | Yes | No | See 05 |
| Automatic Cardiac Phase Search | Yes. CardioHarmony | Yes. CardioHarmony | No |
| Preview Scan | Yes | No | See 06 |
| Double Slice at Axial Scan | Yes. Fine Recon | Yes. Fine Recon | No |
| Priority Recon. | Yes | No | See 07 |
| Dose Report | Yes. Simple Dose Report | Yes. Simple Dose Report | No |
| DICOM | Yes | Yes | No |
| ID Reader | No | No | No |
| Exam Split | Yes | No | See 08 |
| 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 | No | See 09 |

#### Table 2 Technological Characteristic Differences

{6}------------------------------------------------

{7}------------------------------------------------

The differences from the predicate device to SCENARIA Phase 3 are explained in Table 3. Table 3 Analysis of Differences

| Scanning, Reconstruction | | |
|--------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 01 | Image reconstruction time is reduced by enhancing usage efficiency of the image reconstruction system hardware. | |
| Dose Controls | | |
| 02 | This function had been added to SCENARIA Phase 3 by modifying IntelliEC installed in SCENARIA Phase 2. This<br>function performs IntelliEC with previously factored-in noise reduction rate of Intelli IP Advanced. | |
| Features | | |
| 03 | This new feature function had been added by modifying IntelliEC installed in SCENARIA Phase 2. This function<br>performs IntelliEC with previously factored-in noise reduction rate of Intelli IP Advanced. | |

{8}------------------------------------------------

| 04 | This new feature function had been added to SCENARIA Phase 3. This feature modulates tube current corresponding to cardiac phases in ECG Retrospective Scan. |
|----|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 05 | This new feature function had been added by modifying Data Security installed in SCENARIA Phase 2. This function monitors device performance in accordance with IEC62351-8 and NEMA XR-26. |
| 06 | This new feature displays an image at the scan position while scanning in Volume Scan. The system image performance is not affected, as shown in the results of design validation. |
| 07 | This new feature sets the priority of queue recon registration. The system image performance is not affected, as shown in the results of design validation. |
| 08 | This new feature splits the series of scanned images into multiple series. The system image performance is not affected, as shown in the results of design validation. |
| 09 | This new feature function had been added to SCENARIA Phase 3. This function monitors the system performance in accordance with IEC61223-3-5/IEC61223-2-6. The system image performance is not affected, as shown in the results of design validation. |

Therefore, based on a thorough analysis and comparison of the SCENARIA Phase 3 and the predicate device, the technological characteristics do not impact safety and effectiveness.

# Substantial Equivalence

A summary decision was based on analysis of Table 4

Table 4 Rationale Analysis: SCENARIA Phase 3 vs. Predicate

| ITEM | Overall Rationale Analysis |
|----------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Gantry | |
| Detector | There are no functional differences in this item. |
| X-ray Tube | |
| Patient Table | There are no functional differences in this item. |
| Display | There are no functional differences in this item. |
| Image Storage | |
| Scanning, | There are no functional differences in this item. |
| Reconstruction | |
| Performance | There are no substantial differences in this category based on the performance test results. |
| Dose Controls | Different specifications do not constitute a new intended use. There are no significant changes in technological<br>characteristics. For safety, these items are controlled and tested according to same regulations and/or standards as the<br>Predicate. |
| Dose Displays | There are no functional differences in this item. |
| Features | Different specifications do not constitute a new intended use. There are no significant changes in technological<br>characteristics and the feature set of the device is generally equivalent to the 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 SCENARIA Phase 3 is considered substantially equivalent to the currently marketed predicate device (SCENARIA Phase 2 Whole-body X-ray CT System K123509) in terms of design features, fundamental scientific technology, indications for use, and safety and effectiveness.

{9}------------------------------------------------

# Summary of Non-Clinical Testing

## Non-Clinical Testing

The SCENARIA Phase 3 Whole-body X-ray CT System was subjected to the following laboratory testing:

- 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 cycle processes ●

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

Clinical images were collected and analyzed, to ensure that images constructed by the SCENARIA Phase 3 Whole-body X-ray CT System meet user needs.

As a result of the analysis:

| Testing Type | Rationale Analysis |
|-----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Performance Testing -<br>Clinical | We provide five clinical image examples which we judged to be sufficient to judge a clinical usability. The five<br>covered the general anatomy outlined in the indications for use and are comparable to the anatomy examples<br>provided for the predicate. |

# Conclusions

Hitachi believes that, based on the information included in the submission. SCENARIA Phase 3 Whole-body X-ray CT System is substantially equivalent with respect to hardware, base elements of the software, safety, effectiveness, and functionality to the SCENARIA Phase 2 Whole-body X-ray CT System (K123509).