← Product Code [JAK](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/JAK) · K190841
# SCENARIA View (K190841)
_Hitachi Healthcare Americas · JAK · Sep 13, 2019 · Radiology · SESE_
**Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/JAK/K190841
## Device Facts
- **Applicant:** Hitachi Healthcare Americas
- **Product Code:** [JAK](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/JAK.md)
- **Decision Date:** Sep 13, 2019
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 892.1750
- **Device Class:** Class 2
- **Review Panel:** Radiology
## Intended Use
The SCENARIA View system is indicated to acquire axial volumes of the whole body including the head. Images can be acquired in axial, helical, or dynamic modes. The SCENARIA View system can also be used for interventional needle guidance. Volume datasets acquired by a SCENARIA View system can be post-processed in the SCENARIA View system to provide additional information. Post-processing capabilities of the SCENARIA View software include, multi-planar reconstruction (MPR), and volume rendering. Volume datasets acquired by a SCENARIA View system can be transferred to external devices via a DICOM standard interface. The Low Dose CT Lung Cancer Screening Option for the SCENARIA View system is indicated for using low dose CT for lung cancer screening must be conducted with the established program criteria and protocols that have been approved and published by a governmental body, a professional medical society, and/or Hitachi.
## Device Story
Multi-slice CT system; uses 128-slice technology with rotating X-ray tube/detector assembly; collects 64 slices simultaneously; produces cross-sectional images. Used in clinical settings by trained operators. Inputs: X-ray data. Processing: High-speed reconstruction sub-system; iterative reconstruction (Intelli IPV); metal artifact reduction (HiMAR); multi-planar reconstruction (MPR); volume rendering. Outputs: Cross-sectional images displayed on PC-based workstation; stored/archived via DICOM. Benefits: Diagnostic imaging for whole-body assessment and lung cancer screening; interventional guidance support.
## Clinical Evidence
Clinical image study conducted on head, chest, abdomen, and shoulder. Additional clinical evaluation performed for Intelli IPV, FBP, and HiMAR features. Results deemed diagnostic and meeting user needs.
## Technological Characteristics
128-slice CT; 800mm gantry aperture; high-frequency generator; solid-state detector; PC-based workstation (Windows OS). Features: Intelli IPV (iterative reconstruction), HiMAR (metal artifact reduction), Axial Shuttle Scan, Dual Energy Scan. Connectivity: DICOM interface. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-3, IEC 60601-1-6, IEC 60601-2-44, IEC 62304, IEC 62366, NEMA XR 25, NEMA XR 29.
## Regulatory 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 3 Whole-Body X-ray CT System ([K150595](/device/K150595.md))
## Reference Devices
- Supria True 64 ([K171738](/device/K171738.md))
- SCENARIA View Whole-body X-ray CT System ([K180901](/device/K180901.md))
## Submission Summary (Full Text)
> This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com.
>
> Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/).
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image shows 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 the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath in a smaller font.
September 13, 2019
Hitachi Healthcare Americas % Mr. Aaron Pierce Director, RA/QA 1959 Summit Commerce Park TWINSBURG OH 44087
Re: K190841
Trade/Device Name: SCENARIA View Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: Class II Product Code: JAK Dated: August 9, 2019 Received: August 12, 2019
Dear Mr. Pierce:
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
{1}------------------------------------------------
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
### Indications for Use
510(k) Number (if known)
#### K190841
Device Name SCENARIA View
#### Indications for Use (Describe)
The SCENARIA View system is indicated to acquire axial volumes of the whole body including the head. Images can be acquired in axial, helical, or dynamic modes. The SCENARIA View system can also be used for interventional needle guidance.
Volume datasets acquired by a SCENARIA View system can be post-processed in the SCENARIA View system to provide additional information. Post-processing capabilities of the SCENARIA View software include, multi-planar reconstruction (MPR), and volume rendering.
Volume datasets acquired by a SCENARIA View system can be transferred to external devices via a DICOM standard interface.
The Low Dose CT Lung Cancer Screening Option for the SCENARIA View system is indicated for using low dose CT for lung cancer screening must be conducted with the established program criteria and protocols that have been approved and published by a governmental body, a professional medical society, and/or Hitachi.
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."
{3}------------------------------------------------
# Section 5 510(k) Statement or Summary
### Submitter Information
| Submitter: | Hitachi Healthcare Americas
1959 Summit Commerce Park
Twinsburg, Ohio 44087-2371 |
|-------------------------|----------------------------------------------------------------------------------------|
| Contact: | Aaron Pierce |
| Telephone number: | 330-425-1313 |
| Telephone number: | 330-963-0749 |
| E-mail: | piercea@hitachihealthcare.com |
| Date: | November 20, 2018 |
| Subject Device Name | |
| Trade/Proprietary Name: | SCENARIA View |
| 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): | SCENARIA Phase 3 Whole-Body X-ray CT System (K150595) |
| 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 |
## Indications for Use
The SCENARIA View system is indicated to acquire axial volumes of the whole body including the head. Images can be acquired in axial, helical, or dynamic modes. The SCENARIA View system can also be used for interventional needle quidance.
Volume datasets acquired by a SCENARIA View system can be post-processed in the SCENARIA View system to provide additional information. Post-processing capabilities of the SCENARIA View software include, multi-planar reconstruction (MPR), and volume rendering.
Volume datasets acquired by a SCENARIA View system can be transferred to external devices via a DICOM standard interface.
The Low Dose CT Lung Cancer Screening Option for the SCENARIA View system is indicated for using low dose CT for lung cancer screening must be conducted with the established program criteria and protocols that have been approved and published by a governmental body, a professional medical society, and/or Hitachi.
## Device Description
### Function
The SCENARIA View is a multi-slice computed tomography system that uses x-ray data to produce cross-sectional images of the body at various angles.
{4}------------------------------------------------
### Scientific Concepts
The SCENARIA View 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,
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 View 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 SCENARIA View system and the SCENARIA Phase 3 System (K150595) and found to be substantially equivalent.
In addition, evaluations were conducted for dose profile, image noise, Modulation Transfer Function (MTF), slice thickness and sensitivity profile, slice plane location, and CT dose index. These tests and results support inclusion of the Lung Screening Option on the SCENARIA View.
The evaluation results confirm the performance characteristics of the SCENARIA View are comparable to the predicate device and support our conclusion that the subject system is substantially equivalent.
## Device Technological Characteristics
| Systems | SCENARIA View
Subject Device | SCENARIA Phase 3 (K150595)
Predicate Device |
|--------------------------|--------------------------------------------------------------------|------------------------------------------------|
| Physical characteristics | | |
| Gantry | The gantry aperture is expanded to 850 mm by gantry design change. | |
| • Gantry Aperture | 800 [mm] | 750 [mm] |
| Detector | There are not differences between the two systems. | |
| X-ray Tube | There are not differences between the two systems. | |
A summary of the differences is listed in the following table.
{5}------------------------------------------------
Image /page/5/Picture/0 description: The image shows the logo for Hitachi. The word "HITACHI" is written in large, bold, black letters. Below it, in a smaller font, is the phrase "Inspire the Next" also in black, except for a small red accent mark above the letter 't' in "Next".
| Systems | SCENARIA View
Subject Device | SCENARIA Phase 3 (K150595)
Predicate Device |
|-------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------|
| X-ray Generator | There are not differences between the two systems. | |
| Patient Table | Patient Table specifications was revised with the expansion of Gantry aperture. | |
| • Range of Movement, Vertical | 490 to 970 [mm] (CT-WT-23)
490 to 970 [mm] (CT-WT-22) | 465 to 1,050 [mm] (CT-WT-19)
150 to 1,050 [mm] (CT-WT-18L) |
| • Range of Movement, Lateral | 1,750 [mm]
2,000 [mm] (Extended Op.) | 1,750 [mm]
2,000 [mm] (Extended Op.) |
| Display | There are not differences between the two systems. | |
| Image Storage | The hard disk capacity and image storage was increased. | |
| • Hard Disk | 1 [TB] (Image)
3 [TB] (Raw Data) | 250 [GB] (Image)
750 [GB] (Raw Data) |
| • Storage Images | 600,000 | 200,000 |
| Scanning, Reconstruction | The 15 mm collimation was eliminated. | |
| • Collimation | 1.25, 5, 10, 20, 40 [mm] | 1.25, 5, 10, 15, 20, 40 [mm] |
| Performance | There are not differences between the two systems. | |
| Dose Controls | The new iterative reconstruction technique, Intelli IPV was added. | |
| • Iterative Reconstruction | Yes (Intelli IP Advanced, Intelli IPV) | Yes (Intelli IP Advanced) |
| Dose Displays | There are not differences between the two systems. | |
| Features | The new Axial Shuttle Scan and Dual Energy Scan features have been added. HiMAR (metal
artifact reduction technique) has been added which was cleared on the Supria True 64
(K171738).
The Lung Screening Option is available on the SCENARIA View, which was cleared in
K180901. The bench testing was conducted to demonstrate that the SCENARIA View is
substantially equivalent to the predicate evaluated in K180901 (in terms of image quality
metrics such as CT number accuracy, uniformity, noise, etc...) for the task of lung cancer
screening. | |
Therefore, based on a thorough analysis and comparison of subject device (SCENARIA View) and the predicate device, the technological characteristics do not impact safety and effectiveness.
{6}------------------------------------------------
Image /page/6/Picture/0 description: The image contains the logo for Hitachi. The word "HITACHI" is written in large, bold, black letters. Below the company name is the slogan "Inspire the Next" in a smaller font, also in black. The letter "t" in the word "Next" has a small red accent mark.
## Substantial Equivalence
A summary decision was based on a thorough analysis and comparison of the functions, scientific concepts, physical and performance characteristics, performance comparison and technological characteristics.
| ITEM | Overall Rationale Analysis |
|-----------------|-----------------------------------------------------------------------------------------------------------------------------|
| Gantry | There are no significant changes in the SCENARIA View from the predicate device which would affect safety or effectiveness. |
| Detector | |
| X-ray Tube | |
| X-ray Generator | |
| Patient Table | |
| Display | |
| Image Storage | |
| Scanning, | |
| Reconstruction | |
| Performance | |
| Dose Controls | |
| Dose Displays | |
| Features | |
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 View Whole-body X-ray CT System is considered substantially equivalent to the currently marketed predicate device (SCENARIA View Wholebody X-ray CT System (K171738)) in terms of design features, fundamental scientific technology, indications for use, and safety and effectiveness.
{7}------------------------------------------------
Image /page/7/Picture/0 description: The image contains the logo for Hitachi. The word "HITACHI" is written in large, bold, black letters. Below the company name is the slogan "Inspire the Next" in a smaller font size, also in black. The logo is simple and modern, with a focus on the company name and its message of innovation.
## 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.
In addition, the SCENARIA View 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 4.0 .
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 2.1 .
Medical electrical equipment - Part 1-3: General requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment
- IEC 60601-1-6 Edition 3.1
Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
- IEC 60601-2-44 Edition 3.1 Medical electrical equipment Part 2-44: particular requirements for the basic safety and essential performance of x-ray equipment for computed tomography.
- . IEC 62304 Edition 1.1
Medical device software - Software life cycle processes
- IEC 62366 Edition 1.1
Medical devices - Application of usability engineering to medical devices
- NEMA XR 25 Computed Tomography Dose Check
- . NEMA XR29 Standard Attributes on CT Equipment Related to Dose Optimization and Manaqement
## Summary of Clinical Testing
Hitachi has conducted a clinical image study of the head, chest, abdomen, and shoulder that includes an evaluation. In addition, a clinical study was conducted with the Intelli IPV, FBP, and HiMAR features which also includes evaluations. Therefore, based on a thorough analysis and of the clinical images Hitachi believes the SCENARIA View is diagnostic and meet the user needs.
### Conclusions
Hitachi believes that, based on the information included in the submission, SCENARIA View 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 3 Whole-Body X-ray CT System (K150595).
---
**Source:** [https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/JAK/K190841](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/JAK/K190841)
**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).
**Cite:** Innolitics at https://innolitics.com