SCENARIA View Phase 6.0

{0} **FDA** U.S. FOOD & DRUG ADMINISTRATION September 18, 2026 Fujifilm Corporation % Chaitrali Kulkarni Sr. Regulatory Affairs Specialist FUJIFILM Healthcare Americas Corporation 81 HARTWELL AVE. SUITE 100 LEXINGTON, MA 02421 Re: K261229 Trade/Device Name: SCENARIA View Phase 6.0 Regulation Number: 21 CFR 892.1750 Regulation Name: Computed Tomography X-Ray System Regulatory Class: Class II Product Code: JAK Dated: April 14, 2026 Received: August 17, 2026 Dear Chaitrali Kulkarni: 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 (the 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 available 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. U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov {1} K261229 - Chaitrali Kulkarni Page 2 Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). Your device is also subject to, among other requirements, the Quality Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3). 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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/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-devices/device-advice-comprehensive-regulatory- {2} K261229 - Chaitrali Kulkarni Page 3 assistance/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, Lu Jiang, Ph.D. Assistant Director DHT8B: Division of Radiologic Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {3} DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration # **Indications for Use** Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below. 510(k) Number (if known) K261229 Device Name SCENARIA View Phase 6.0 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. The 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 FUJIFILM Corporation. AI/ML algorithms are used for Intelli IPV, AutoPose, AutoPositioning, DLR and Automatic Head Slice Setting. Intelli IPV is developed using machine learning as AI technology to the iterative practical reconstruction automatically. AutoPose is developed using deep learning as AI technology to detect landmarks or regions from a scanogram image. When using AutoPose, be sure to visually check the scan range and adjust it if necessary. AutoPositioning is developed using deep learning as AI technology to detect the patient's feature points. This function assists in patient positioning operations. Therefore, after completing the positioning operation, be sure to visually check the patient's positioning and the table position by using the light localizer. DLR Focus is developed using deep learning as AI technology to reduce image noise through convolutional processing based on a model obtained by deep learning. Automatic Head Slice Setting is developed using deep learning as AI technology to perform brain region segmentation, brain centroid calculation, and feature point extraction from head volume data. AutoPose, AutoPositioning, DLR Focus and Automatic Head Slice Setting are for adult use only. 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) **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 FDA 3881 (8/23) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF {4} **FUJIFILM** Value from Innovation K261229 ## 510(k) Summary ### Contact Details | Applicant Name | Fujifilm Corporation | | --- | --- | | Applicant Address | 81 Hartwell Ave. Suite 100, Lexington, Massachusetts, 02421, USA | | Applicant Contact: | Chaitrali Kulkarni, Sr Regulatory Affairs Specialist | | Applicant Contact Telephone | (704)-517-4886 | | Applicant Contact Email | hcusregulatoryaffairs@fujifilm.com | | Applicant Date | March 25, 2026 | ### Subject Device Name | Device Trade Name | SCENARIA View Phase 6.0 | | --- | --- | | Common Name | System, x-ray, tomography, computed | | Classification Name | Computed Tomography X-ray System | | Regulation Number | 892.1750 | | Product Code(s) | JAK | ### Predicate Device Name | Predicate # | K250370 | | --- | --- | | Device Trade Name | SCENARIA View Phase 5.0 | | Common Name | System, x-ray, tomography, computed | | Classification Name | Computed tomography x-ray system | | Regulation Number | 892.1750 | | Product Code(s) | JAK | Page | 1 of 7 {5} **FUJIFILM** Value from Innovation ## Device Description Summary The SCENARIA View Phase 6.0 is a multi-slice computed tomography system that uses x-ray data to produce cross-sectional images of the body at various angles. The SCENARIA View Phase 6.0 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. The subject device SCENARIA View Phase 6.0 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 SCENARIA View Phase 5.0 system. The subject device has added the following modifications from predicate device SCENARIA View Phase 5.0 system: - • guideShot has been improved. - - A continuous fluoroscopy scan method has been added. The continuous fluoroscopy scan method uses the same technology as the existing continuous dynamic scan. - - For the one-shot scan method, a function to display and save MPR cross-sectional images after each scan has been added. - • IntelliODM has been added. - - This feature utilizes IntelliEC technology to reduce X-ray exposure to the patient's head and chest, thereby lowering the direct radiation dose to sensitive organs. - - IntelliEC is a feature incorporated in the predicate device. - • DLR Focus has been added. - - This feature is the deep-learning reconstruction method that performs denoising. - - This feature can reduce image noise compared to the conventional reconstruction method, CORE Plus, which is used as the predicate device. - • Automatic Head Slice Setting Function has been added. - - This feature has been added as one of the MPR functions. - - This feature automatically adjusts the cross-sectional angle to align with the OM line, rotates the body axis to face directly upward, and sets the normal direction range and FOV to appropriate ranges when setting the MPR image creation range for head data. - - This feature uses a deep learning algorithm as part of the process. - • Body StillShot has been improved. - - This feature has been expanded to include not only chest examinations but also head and abdominal examinations. Page | 2 of 7 {6} **FUJIFILM** Value from Innovation ## Intended Use/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 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. The 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 FUJIFILM Corporation. AI/ML algorithms are used for Intelli IPV, AutoPose, AutoPositioning, DLR and Automatic Head Slice Setting. Intelli IPV is developed using machine learning as AI technology to the iterative practical reconstruction automatically. AutoPose is developed using deep learning as AI technology to detect landmarks or regions from a scanogram image. When using AutoPose, be sure to visually check the scan range and adjust it if necessary. AutoPositioning is developed using deep learning as AI technology to detect the patient's feature points. This function assists in patient positioning operations. Therefore, after completing the positioning operation, be sure to visually check the patient's positioning and the table position by using the light localizer. DLR Focus is developed using deep learning as AI technology to reduce image noise through convolutional processing based on a model obtained by deep learning. Automatic Head Slice Setting is developed using deep learning as AI technology to perform brain region segmentation, brain centroid calculation, and feature point extraction from head volume data. AutoPose, AutoPositioning, DLR Focus and Automatic Head Slice Setting are for adult use only. ## Indications for Use Comparison No difference in indications for use. Page | 3 of 7 {7} **FUJIFILM** Value from Innovation ## Device Technological Characteristics A summary of the differences is listed in the following table. | Systems | SCENARIA View Phase 6.0 Subject Device | SCENARIA View Phase 5.0 (K250370) Predicate Device | | --- | --- | --- | | **Physical characteristics** | | | | **Gantry** | There are no differences between the two systems. | | | **Detector** | There are no differences between the two systems. | | | **X-ray Tube** | There are no differences between the two systems. | | | **X-ray Generator** | There are no differences between the two systems. | | | **Patient Table** | There are no differences between the two systems. | | | **Operator's console** | There are no differences between the two systems. | | | **Scanning** | There are no differences between the two systems. | | | **Reconstruction** | There are no differences between the two systems. | | | **Performance** | There are no differences between the two systems. | | | **Dose Controls** | There are no differences between the two systems. | | | **Dose Displays** | There are no differences between the two systems. | | | **Features** | guideShot Scan was improved by adding the continuous scan. MPR was improved by adding the Automatic Head Slice Setting function. Motion corrected reconstruction was improved by adding the target region. New features of IntelliODM and DLR Focus were added to the subject device. | | Therefore, based on a thorough analysis and comparison of subject device and the predicate device, the technological characteristics do not impact safety and effectiveness. Page | 4 of 7 {8} **FUJIFILM** Value from Innovation ## 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 | No changes | | Detector | No changes | | X-ray Tube | No changes | | X-ray Generator | No changes | | Patient Table | No changes | | Operator's console | No changes | | Scanning | No changes | | Reconstruction | No changes | | Performance | No changes | | Dose Controls | No changes | | Features | Different specifications do not constitute a new intended use. There are no significant changes in technological characteristics and the feature set of the device is generally equivalent to the predicate device. | 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 Phase 6.0 is considered substantially equivalent to the currently marketed predicate device (SCENARIA View Phase 5.0 (K250370)) in terms of design features, fundamental scientific technology, indications for use, and safety and effectiveness. Page | 5 of 7 {9} **FUJIFILM** Value from Innovation ## Summary of Non-Clinical Testing 21 CFR 1020.33(c)(g) 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. (There are no changes in these performance items.) 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 4.1 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 2.2 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 3.2 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 - NEMA XR 25 Computed Tomography Dose Check ### IntelliODM Performance test of IntelliODM was conducted using phantoms. For both the head and chest, the evaluation was performed from the perspectives of image noise and tube current modulation. As a result of the evaluation for image noise, it was confirmed that when the IntelliEC Plus function was not used, the measured SD values were within ±20% of the target SD value or the assumed image SD value, and that when the IntelliEC Plus function was used, the error between the image SD value with CORE Plus and the image SD value with IPV was within the allowable range. In addition, for tube current modulation, it was confirmed that the tube current graphs of the planned values at scan planning and the actual values during scanning matched. ### guideShot Performance test of guideShot was evaluated from the perspectives of MPR display performance and axial image display performance in the Continuous Method. As a result of the evaluation, for MPR display performance, it was confirmed that the time from the start of the X-ray exposure operation to completion of the MPR display was 5 seconds or less, and for axial image display performance in the Continuous Method, it was confirmed that the average refresh rate of axial images during X-ray exposure was 0.1 second per image. Page | 6 of 7 {10} **FUJIFILM** Value from Innovation ## Summary of Clinical Testing The validation results of the new features using machine learning (DLR Focus and MPR(Automatic Head Slice Setting function)) were described below. ### DLR Focus Performance tests of DLR Focus were conducted by using phantoms in terms of image noise reduction, high-contrast spatial resolution, and structural blur. The phantom testing demonstrated that DLR Focus could reduce image noise by using the metric of image SD. The phantom testing also demonstrated that DLR Focus did not degrade the image quality by using the metrics of modulation transfer function (MTF) and structural blur index. In addition, three US board-certified radiologists reviewed the image quality of clinical images reconstructed with DLR Focus in terms of image noise, edge preservation, low contrast visibility, lesion conspicuity, and overall image quality. Images reconstructed with either the conventional method or DLR Focus were randomized, blinded to the reviewers, and compared for image quality metrics (noise level, edge preservation, low contrast visibility, lesion conspicuity, and overall image quality) using a 3-point scale. All images used for this comparison were also evaluated by the reviewers in terms of clinical acceptability. A total of 51 unique patients (35 males, 16 females; age range, 18–87 years; BMI range, 16.5–40.6) who underwent chest CT examinations and 47 unique patients (17 males, 30 females; age range, 18–94 years; BMI range, 14.7–47.8) who underwent abdominal CT examinations were scanned using a FUJIFILM 64-slice multidetector CT scanner (SCENARIA View) to provide the test datasets. The test datasets were independent of the training dataset. The review results indicated that image noise, edge preservation, low contrast visibility, lesion conspicuity, and overall image quality in the images reconstructed with DLR Focus were superior to those in the conventional images with a statistically significant difference ($p<0.05$). All images reconstructed from DLR Focus were evaluated as clinically acceptable by the reviewers. In conclusion, the phantom testing and the clinical image testing demonstrated that DLR Focus could reduce image noise and did not degrade the image quality compared to the conventional method. ### MPR(Automatic Head Slice Setting function) Automatic Head Slice Setting was evaluated by three U.S.-certified radiologic technologists. For each dataset automatically configured by Automatic Head Slice Setting, they reviewed the parameters for rotation, tilt, normal direction range, and FOV to assess whether the manual adjustment work previously required was reduced. As a result of the evaluation, a reduction in adjustment work was judged in 95% of the evaluation datasets, confirming that the acceptance criterion was exceeded. ### Body StillShot Body StillShot was evaluated by Japanese physicians from the standpoint of image quality. Images reconstructed with and without Body StillShot using the SCENARIA View Phase 6.0 system were compared, and the effect of motion artifact reduction was visually assessed. As a result of the evaluation, Body StillShot was judged to be capable of providing images of sufficient quality. ## Conclusions FUJIFILM believes that, based on the information included in the submission, SCENARIA View Phase 6.0 subject device is substantially equivalent with respect to hardware, base elements of the software, safety, effectiveness, and functionality to the SCENARIA View Phase 5.0 (K250370). Page | 7 of 7