FCT iStream Phase 2
Device Facts
| Record ID | K253836 |
|---|---|
| Device Name | FCT iStream Phase 2 |
| Applicant | Fujifilm Corporation |
| Product Code | JAK · Radiology |
| Decision Date | Sep 4, 2026 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1750 |
| Device Class | Class 2 |
| Attributes | AI/ML, Real-World Evidence |
Real-World Evidence
| Submission | Device | Sponsor | RWD Sources | RWE Use Summary | Key Tags |
|---|---|---|---|---|---|
| K253836 · Sep 4, 2026 | FCT iStream Phase 2 | Fujifilm Corporation | Routine clinical care medical records/images | Retrospective clinical image evaluation of three patients undergoing routine chest CT examinations to assess the performance of the Body StillShot motion-correction feature. | Body StillShot; Routine clinical care; Retrospective image evaluation |
Clinical Evidence
| Study Design | Population | Comparator | Key Endpoints |
|---|---|---|---|
| Clinical image evaluation for Body StillShot; Retrospective clinical image evaluation | Three adult patients undergoing chest CT examinations; Sample Size: 3 | Images reconstructed without Body StillShot | Visual assessment of motion artifacts and visualization of anatomical structures (heart, aorta, blood vessels, bronchi) |
AI Performance
| Output | Algorithm | Acceptance | Observed | Dev DS | Dev Readers | Test DS | Test Readers |
|---|---|---|---|---|---|---|---|
| Scan range planning | Deep learning | Reduction in manual adjustment operations > 90% | 98.9% | — | — | 84 unique adult subjects and 415 unique scanogram images | 3 (US-certified radiologic technologists) |
| Patient positioning | Deep learning | No manual adjustment or adjustment of only one parameter > 90% | 97.2% | — | — | 39 unique adult healthy volunteers and 1,092 unique evaluation cases | 5 (US-certified radiologic technologists) |
Indications for Use
The FCT iStream 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 FCT iStream system can also be used for interventional needle guidance. Volume datasets acquired by an FCT iStream system can be post-processed in the FCT iStream system to provide additional information. Post-processing capabilities of the FCT iStream software include multi-planar reconstruction (MPR), and volume rendering. Volume datasets acquired by an FCT iStream system can be transferred to external devices via a DICOM standard interface. The Low Dose CT Lung Cancer Screening Option for the FCT iStream 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.
Device Story
Multi-slice CT system; acquires x-ray data for cross-sectional body imaging. Inputs: x-ray projections; scanogram images; 3D camera data for patient positioning. Processing: iterative reconstruction (Intelli IPV); deep learning-based AI for landmark detection (AutoPose) and patient feature point detection (AutoPositioning); motion-correction algorithms (Cardio StillShot, Body StillShot) using GPU-enabled console. Outputs: cross-sectional images; MPR; volume rendering. Used in clinical settings by radiologic technologists/physicians. AI functions assist scan planning and patient positioning; operators must verify and manually adjust outputs. Benefits: reduced manual adjustment, improved workflow efficiency, and motion artifact reduction for cardiac/chest exams.
Clinical Evidence
Bench testing per IEC 61223-3-5; phantom studies for Cardio/Body StillShot. AutoPose evaluated on 84 subjects/415 scanograms; 98.9% reduction in manual adjustments. AutoPositioning evaluated on 39 volunteers/1,092 cases; 97.2% required minimal/no adjustment. Body StillShot supported by clinical image evaluation of 3 patients showing reduced motion artifacts. No clinical trials required for substantial equivalence.
Technological Characteristics
Multi-slice CT system; gantry; patient table (up to 300kg); GPU-enabled operator console. AI/ML algorithms: Intelli IPV (iterative reconstruction), AutoPose, AutoPositioning (deep learning). Connectivity: DICOM standard interface. Accessories: Headrest 3, Flap Sheet, Armrest HF. Standards: IEC 61223-3-5, 21 CFR 1020.33.
Indications for Use
Indicated for adult patients requiring whole-body CT imaging, including head, in axial, helical, or dynamic modes; interventional needle guidance; and low-dose lung cancer screening per established protocols. AutoPose and AutoPositioning features are restricted to adult use only.
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 View Phase 5.0 (K250370)
Reference Devices
- FCT iStream Phase 1 (K233583)
Submission Summary (Full Text)
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**FDA** U.S. FOOD & DRUG
ADMINISTRATION
September 4, 2026
FUJIFILM Corporation
% Chaitrali Kulkarni
Sr. Regulatory Affairs Specialist
Fujifilm Healthcare Americas Corporation
81 Hartwell Ave. Suite 100
LEXINGTON, MA 02421
Re: K253836
Trade/Device Name: FCT iStream Phase 2
Regulation Number: 21 CFR 892.1750
Regulation Name: Computed Tomography X-Ray System
Regulatory Class: Class II
Product Code: JAK
Dated: August 7, 2026
Received: August 7, 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.
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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-
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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
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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)
K253836
Device Name
FCT iStream Phase 2
Indications for Use (Describe)
The FCT iStream 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 FCT iStream system can also be used for interventional needle guidance. Volume datasets acquired by an FCT iStream system can be post-processed in the FCT iStream system to provide additional information. Post-processing capabilities of the FCT iStream software include multi-planar reconstruction (MPR), and volume rendering. Volume datasets acquired by an FCT iStream system can be transferred to external devices via a DICOM standard interface.
The Low Dose CT Lung Cancer Screening Option for the FCT iStream 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 and AutoPositioning.
Intelli IPV is an iterative image reconstruction function incorporating machine learning-based AI technology.
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.
AutoPose and AutoPositioning 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.
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*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*
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FORM FDA 3881 (8/23)
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PSC Publishing Services (301) 443-6740 EF
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**FUJIFILM**
Value from Innovation
K253836
## 510(k) Summary
### Contact Details
| Applicant Name | FUJIFILM Corporation |
| --- | --- |
| Applicant Address | 26-30, Nishiazabu 2-chome, Minato-ku, Tokyo 106-8620, JAPAN |
| Applicant Contact Telephone | (704)-517-4886 |
| Applicant Contact | Chaitrali Kulkarni, Senior Regulatory Affairs Specialist |
| Applicant Contact Email | hcusregulatoryaffairs@fujifilm.com |
| Applicant Date: | November 26, 2025 |
### Device Name
| Device Trade Name | FCT iStream Phase 2 |
| --- | --- |
| Common Name | System, x-ray, tomography, computed |
| Classification Name | Computed tomography x-ray system |
| Regulation Number | 892.1750 |
| Product Code(s) | JAK |
### Legally Marketed Predicate Device and Reference Device
#### Primary Predicate Device
| 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 |
#### Reference Device
| Reference Device # | K233583 |
| --- | --- |
| Device Trade Name | FCT iStream Phase 1 |
| Common Name | System, x-ray, tomography, computed |
| Classification Name | Computed tomography x-ray system |
| Regulation Number | 892.1750 |
| Product Code(s) | JAK |
The Reference Device is used only to provide supplementary information regarding the FCT iStream platform and is not used as the predicate device for the substantial equivalence determination.
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Value from Innovation
K253836
# Device Description Summary
# [Device Functions]
The subject device FCT iStream Phase 2 is a multi-slice CT system that uses x-ray data to produce cross-sectional images of the body at various angles.
# [FCT iStream Phase 2 Modifications]
The following functions and configurations have been added or modified from FCT iStream Phase 1 (K233583) (Reference Device):
- AutoPose has been expanded to support 14 anatomical regions using the same AI-based technology as the Primary Predicate Device.
- AutoPositioning, intended to assist in positioning the patient using a camera, has been added using the same AI-based technology as the Primary Predicate Device.
- Cardio StillShot, intended to reduce motion artifacts caused by cardiac motion in cardiac examinations, has been added.
- Body StillShot, intended to reduce motion artifacts caused by body motion in chest examinations, has been added.
- A new operator's console configuration incorporating a GPU has been added to support Cardio StillShot and Body StillShot.
- A patient table configuration with a maximum load capacity of 300 kg has been added.
- The Flap Sheet and Armrest HF have been improved.
- Headrest 3 has been added.
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K253836
## Intended Use/Indications for Use
The FCT iStream 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 FCT iStream system can also be used for interventional needle guidance. Volume datasets acquired by an FCT iStream system can be post-processed in the FCT iStream system to provide additional information. Post-processing capabilities of the FCT iStream software include multi-planar reconstruction (MPR), and volume rendering. Volume datasets acquired by an FCT iStream system can be transferred to external devices via a DICOM standard interface.
The Low Dose CT Lung Cancer Screening Option for the FCT iStream 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 and AutoPositioning.
Intelli IPV is an iterative image reconstruction function incorporating machine learning-based AI technology.
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.
AutoPose and AutoPositioning are for adult use only.
## Indications for Use Comparison
No difference in indications for use.
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Value from Innovation
K253836
## Technological Characteristics Comparison
FCT iStream Phase 2 and the Primary Predicate Device, SCENARIA View Phase 5.0 (K250370), have the same intended use and the same fundamental scientific technology as multi-slice CT systems.
| Category | Supporting Device | Comparison Summary |
| --- | --- | --- |
| CT System | SCENARIA View Phase 5.0 (K250370) | Both devices are multi-slice CT systems with axial, helical, and dynamic scan capabilities and have the same intended use and fundamental scientific technology. |
| CT Acquisition Components | FCT iStream Phase 1 (K233583) | The subject device uses established FCT iStream CT acquisition components. Differences from the Primary Predicate Device are supported by comparison to the Reference Device and applicable performance testing. |
| Gantry | FCT iStream Phase 1 (K233583) | The subject-device gantry configuration is the same as the Reference Device. Differences from the Primary Predicate Device do not alter the intended use. |
| Patient Table | FCT iStream Phase 1 (K233583); SCENARIA View Phase 5.0 (K250370) | The established patient-table configuration is supported by the Reference Device. The subject device also includes a patient-table configuration with a maximum load capacity of 300 kg, which is also available in the Primary Predicate Device. Differences from the Primary Predicate Device do not alter the intended use and are supported by applicable performance testing. |
| Operator's Console | FCT iStream Phase 1 (K233583); SCENARIA View Phase 5.0 (K250370) | The established operator's console configuration is supported by the Reference Device. The subject device also includes a GPU-enabled operator's console configuration to support Cardio StillShot and Body StillShot; a corresponding GPU-enabled operator's console configuration is included in the Primary Predicate Device. |
| Image Reconstruction and Dose Control | FCT iStream Phase 1 (K233583) | The subject device includes established FCT iStream image reconstruction and dose-control functions. Intelli IPV is an existing iterative image reconstruction function and is not newly added or modified in FCT iStream Phase 2. |
| AutoPose | SCENARIA View Phase 5.0 (K250370) | The subject device supports AutoPose using the same AI-based technology and for the same 14 anatomical regions as the Primary Predicate Device. |
| AutoPositioning | SCENARIA View Phase 5.0 (K250370) | The subject device includes AutoPositioning using the same AI-based technology and for the same supported anatomical regions as the Primary Predicate Device. |
| Motion-Corrected Reconstruction | SCENARIA View Phase 5.0 (K250370) | Both devices include motion-corrected reconstruction functions for cardiac and body applications, including Cardio StillShot and Body StillShot. |
| Accessories | Not applicable | The subject device includes Headrest 3, which is not included in either comparison device. This accessory difference was evaluated through applicable performance testing and does not alter the intended use or raise different questions of safety or effectiveness. |
The technological differences between the subject device and the Primary Predicate Device were evaluated through device comparison, applicable standards testing, bench performance testing, risk management activities, labeling, and function-specific performance testing, as applicable. The results support that the subject device is as safe and effective as the Primary Predicate Device and does not raise different questions of safety and effectiveness. Therefore, FCT iStream Phase 2 is substantially equivalent to SCENARIA View Phase 5.0 (K250370).
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K253836
## Performance Testing
Non-clinical performance testing was conducted to evaluate the basic performance, safety, and essential performance of FCT iStream Phase 2. Testing included CT system bench performance testing, patient-table testing, Flap Sheet testing, and image-quality evaluation of Armrest HF and Headrest 3. The subject device met the applicable acceptance criteria for the evaluated tests.
## CT System Bench Performance Testing
Bench testing based on IEC 61223-3-5 was conducted to evaluate CT system performance. The subject device met the applicable conditions of 21 CFR 1020.33(c) or (g) for the evaluated parameters, including spatial resolution, noise, mean CT number and uniformity, and tomographic section thickness.
## Standards Testing
The subject device was tested for conformance with applicable portions of electrical safety, electromagnetic compatibility, radiation protection, CT safety and essential performance, software lifecycle, and CT dose-check standards.
## AutoPose
AutoPose is a scan-planning assistance function that analyzes scanogram images and displays a proposed scan range for operator review. AutoPose does not autonomously finalize the scan range for clinical use. Before initiating the CT scan, the operator must visually verify the proposed scan range and manually adjust it as necessary. The operator may disable AutoPose and use the conventional manual scan-range-setting workflow.
Performance evaluation was conducted using clinical scanogram images acquired with the final finished FCT iStream Phase 2 system with System Software V5.1. The clinical image dataset was independent of the datasets used for AutoPose training, validation, and algorithm development.
The dataset included 84 unique adult subjects and 415 unique scanogram images. AutoPose was applied to each scanogram image, and each AutoPose result image was independently evaluated by three U.S.-certified radiologic technologists, for a total of 1,245 evaluations.
The evaluation assessed whether AutoPose reduced the number of manual adjustment operations required to make the proposed scan range appropriate for the planned examination compared with the conventional manual scan-range-setting workflow. In 98.9% of evaluations, AutoPose reduced the number of required manual adjustment operations compared with the conventional manual workflow, exceeding the predefined acceptance criterion of 90%. In all evaluations, the AutoPose result required fewer manual adjustment operations than the conventional manual workflow.
AutoPose uses scanogram images acquired as part of the standard CT examination and does not introduce additional patient contact or x-ray exposure. No additional AutoPose-specific adverse effects or complications are expected beyond those associated with the standard CT examination.
The performance results and the operator verification, manual-adjustment, and AutoPose-disable controls support that AutoPose does not raise different questions of safety or effectiveness compared with the Primary Predicate Device.
## AutoPositioning
AutoPositioning is a patient-positioning assistance function that uses a 3D camera to assist the operator in positioning adult patients for scanogram acquisition. AutoPositioning does not autonomously finalize the patient position for clinical use. Before initiating the CT scanogram, the operator must use the light localizer to visually verify the patient position and patient-table position and manually adjust the applicable positioning parameters as necessary. The operator may disable AutoPositioning and use the conventional manual patient-positioning workflow.
Performance evaluation was conducted using RGB image data and depth information acquired with the final finished FCT iStream Phase 2 system with System Software V5.1. The clinical test dataset included 39 unique adult healthy volunteers and 1,092 unique AutoPositioning evaluation cases across 14 anatomical regions and two evaluation conditions per anatomical region.
Each evaluation case was evaluated by one of five U.S.-certified radiologic technologists. The evaluation
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K253836
assessed whether AutoPositioning reduced the number of manual adjustment operations required to set the scanogram start position compared with the conventional manual patient-positioning workflow.
In 97.2% of evaluation cases, no manual adjustment or adjustment of only one positioning parameter was required after AutoPositioning moved the patient table. This result exceeded the predefined acceptance criterion of 90% or greater. The lower limit of the two-sided Wilson 95% confidence interval was 96.0%, which also exceeded the predefined acceptance criterion.
AutoPositioning uses a camera to assist patient positioning and does not introduce additional x-ray exposure. No additional AutoPositioning-specific adverse effects or complications are expected beyond those associated with the standard CT examination.
The performance results and the required operator verification, manual adjustment, and AutoPositioning-disable controls support that AutoPositioning does not raise different questions of safety or effectiveness compared with the Primary Predicate Device.
### **Cardio StillShot**
Cardio StillShot is an image reconstruction feature intended to reduce motion artifacts caused by cardiac motion in CT images. Performance testing was conducted using the final finished FCT iStream Phase 2 configuration.
Nonclinical performance testing included a digital cardiac phantom evaluation, a physical phantom image evaluation, and a reconstruction throughput evaluation. No clinical testing was conducted, submitted, referenced, or relied upon to support substantial equivalence for Cardio StillShot.
The digital cardiac phantom evaluation assessed effective temporal resolution and preservation of simulated cardiac structures at heart rates of 60, 70, and 80 bpm. Cardio StillShot achieved effective temporal resolutions of 13 ms, 19 ms, and 28 ms at 60 bpm, 70 bpm, and 80 bpm, respectively. These results met the predefined acceptance criterion of 44 ms or less at heart rates of 80 bpm or lower. The physical phantom image evaluation compared Cardio StillShot ON and OFF reconstructions using identical raw data acquired during an ECG prospective scan performed using a thoracic phantom. The evaluation visually assessed reduction of motion artifacts under the evaluated reconstruction conditions. Because no clinical testing was conducted or relied upon for Cardio StillShot, clinical subjects, adverse effects, and complications were not evaluated for this function. The nonclinical performance testing demonstrated that Cardio StillShot performs as intended under the evaluated conditions and does not raise different questions of safety or effectiveness compared with the Primary Predicate Device.
### **Body StillShot**
Body StillShot is an image reconstruction feature intended to reduce motion-related artifacts in body CT images. Performance testing was conducted using the final finished FCT iStream Phase 2 configuration. Nonclinical performance testing included a Physical Phantom Image Evaluation and a Reconstruction Throughput Evaluation. In the Physical Phantom Image Evaluation, CT raw data acquired using a thoracic phantom under volume scan and normal scan conditions were used to reconstruct Body StillShot OFF and Body StillShot ON images. For each scan condition, the OFF and ON images were reconstructed from the same CT raw data using identical post-reconstruction parameters except for the Body StillShot setting.
For both evaluated scan conditions, motion artifacts in the Body StillShot ON images were visually assessed to be smaller than those in the corresponding Body StillShot OFF images, meeting the predefined acceptance criterion. The Reconstruction Throughput Evaluation was performed in three independent post-reconstruction runs using the same CT raw data and post-reconstruction conditions. The mean reconstruction throughput was 20.51 images per second, exceeding the predefined acceptance criterion of not less than 10 images per second.
A supporting clinical image evaluation was submitted as Appendix A to the Body StillShot Performance Testing report. The clinical image evaluation included three adult patients undergoing chest CT examinations as part of routine clinical care. Clinical images acquired with the FCT iStream Phase 2 subject device were reconstructed with and without Body StillShot and visually evaluated. In the evaluated cases, images reconstructed with Body StillShot showed reduced motion artifacts and improved visualization of the heart, ascending aorta, blood vessels, and bronchi compared with images
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Value from Innovation
K253836
reconstructed without Body StillShot. In two cases, motion artifacts on images reconstructed without Body StillShot raised concern for possible aortic dissection; images reconstructed with Body StillShot enabled visualization of the ascending aorta without findings of aortic dissection.
Body StillShot is a post-reconstruction function and does not introduce additional patient contact or x-ray exposure. No additional Body StillShot-specific adverse effects or complications are expected beyond those associated with the standard CT examination.
Together, the nonclinical performance testing and supporting clinical image evaluation demonstrate that Body StillShot performs as intended under the evaluated conditions and does not raise different questions of safety or effectiveness compared with the Primary Predicate Device.
The performance testing results support that FCT iStream Phase 2 is as safe and effective as the Primary Predicate Device and does not raise different questions of safety and effectiveness.
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## Conclusions
Based on the device comparison, applicable standards testing, bench performance testing, risk management activities, labeling, and function-specific performance testing, FUJIFILM concludes that FCT iStream Phase 2 has the same intended use as, is as safe and effective as, and does not raise different questions of safety and effectiveness compared with the Primary Predicate Device, SCENARIA View Phase 5.0 (K250370).
Therefore, FCT iStream Phase 2 is substantially equivalent to SCENARIA View Phase 5.0 (K250370).
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