SCENARIA View Phase 5.0
K250370FUJIFILM Corporation · cleared 2025-05-20 · product code JAK · Radiology
Premarket evidence — what FDA accepted
source quote (p.5)
“The subject device SCENARIA View is a multi-slice CT 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. AutoPose is an AI-based function that recognizes a specific body part in an image of localization scan and then automatically sets the scan range and the image reconstruction range.”
source quote (p.6)
“AutoPose is an AI-based function that recognizes a specific body part in an image of localization scan and then automatically sets the scan range and the image reconstruction range.”
source quote (p.8)
“The basic algorithm of AutoPositioning has not been changed and carry out the necessary verifications (intended use, functionality, safety) and increase the number of support parts.”
Validation studies (5)
Bench
sample size not stated
endpoints: Spatial Resolution; Noise; Mean CT number and Uniformity; Tomographic Section Thickness
standards: IEC61223-3-5, ANSI AAMI ES60601-1:2005/(R)2012 & A1:2012 C1:2009/(R)2012 & A2:2010/(R)2012 (Cons. Text) [Incl. AMD2:2021], IEC 60601-1:2005, MOD, IEC 60601-1-2 Edition 4.1, IEC 60601-1-3 Edition 2.2, IEC 60601-2-44 Edition 3.2, IEC 62304 Edition 1.1, NEMA XR 25 Computed Tomography Dose Check
Bench
sample size not stated
standards: IEC60601-1, IEC 60601-2-44
Bench
sample size not stated
endpoints: workflow improvements due to reduced steps identification
Reader study (MRMC)
n=432 cases · 1 site(s)
endpoints: reduces the number of steps compared to the conventional manual operation
Reader study (MRMC)
sample size not stated
endpoints: obtain images of sufficient quality
Reported performance (0 observations)
FDA source did not state a quantitative performance metric — non-reporting is itself the signal.
Each value carries its own analysis unit and task — never compare or pool across devices. Source: 510(k) summary PDF.
Predicate network
Postmarket — what happened after clearance
- recall_reason_pattern
Software/algorithm-related recall in product code JAK (GE Medical Systems, LLC, initiated 2026-03-26): "GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed via Edison Health Link (EHL) based CT Smart Subscription used in conjunction with " Recalling firm is another firm in the same product code.
first seen 2026-07-08 · recall res_event_number:98738
- recall_reason_pattern
Software/algorithm-related recall in product code JAK (PHILIPS MEDICAL SYSTEMS, initiated 2026-03-07): "Philips has identified three software issues: 1. During a continuous CT (CCT) scan, there is the potential that the Gantry could remain at the current scan position after pressing" Recalling firm is another firm in the same product code.
first seen 2026-07-08 · recall res_event_number:98588
- recall_reason_pattern
Software/algorithm-related recall in product code JAK (Siemens Medical Solutions USA, Inc, initiated 2025-12-19): "To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance." Recalling firm is another firm in the same product code.
first seen 2026-07-08 · recall res_event_number:98206
- recall_reason_pattern
Software/algorithm-related recall in product code JAK (PHILIPS MEDICAL SYSTEMS, initiated 2025-09-25): "Issue 1: The potential for unintentional continued gantry/couch movement when a specific button series is used requiring use of manual stop. Issue 2. When performing a helical/Axia" Recalling firm is another firm in the same product code.
first seen 2026-07-08 · recall res_event_number:97699
- recall_reason_pattern
Software/algorithm-related recall in product code JAK (Philips North America Llc, initiated 2025-05-29): "Devices with affected software may experience two unintended motion issues that may lead to contact between the Gantry or table with the operator or patient, along with additional " Recalling firm is another firm in the same product code.
first seen 2026-07-08 · recall res_event_number:97010
- recall_reason_pattern
Software/algorithm-related recall in product code JAK (, initiated 2025-05-23): "Due to a software bug the robotic arm may incorrectly guide the instrument compared to the planning defined by user." Recalling firm is another firm in the same product code.
first seen 2026-07-08 · recall res_event_number:96967
- …and 3 more.
Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device). Signals are descriptive observables with sources — never a judgment that the device is unsafe or drifting. Snapshot 2026-07-08.
Reimbursement — how devices like this got paid
Not yet tracked — no payment pathway indexed for this clearance (the reimbursement corpus is a growing seed set).