Spectral CT Verida Family
K253649Philips Medical Systems Technologies , Ltd. · cleared 2026-03-27 · product code JAK · Radiology
Premarket evidence — what FDA accepted
source quote (p.4)
“The system incorporates both conventional iterative reconstruction (IR) and artificial intelligence (AI)-based reconstruction functionality.”
source quote (p.4)
“Spectral Precise Image (SPI) is an AI-based deep learning reconstruction feature intended to optimize image quality by reducing noise and enhancing image appearance in Head, Whole Body, Cardiac, and Vascular X-ray Computed Tomography applications.”
source quote (p.36)
“The cybersecurity testing for the Spectral CT Verida Family system was conducted in accordance with FDA-recognized consensus standards and specifically aligns with the following FDA guidance: • Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions (FDA, June 27, 2025)”
Validation studies (2)
Bench
n=35 scans
endpoints: CT number linearity; image noise; uniformity; contrast-to-noise ratio (CNR); spatial resolution (MTF and SSP); low contrast resolution (visual); image artifacts; Monochromatic energy (MonoE, HU); virtual non-contrast (VNC, HU); iodine density (mg/ml); iodine no water (mg/ml); iodine removed (HU); contrast-enhanced structures (HU); calcium suppression (HU); Z effective; electron density (%EDW); uric acid and uric acid removed (HU)
standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-3, IEC 60601-1-6, IEC 60601-2-28, IEC 60601-2-44, IEC 60825-1, IEC 62304, IEC 62366-1, ISO 14971, ISO 10993-1
Reader study (MRMC)
n=147 scans · 2 site(s)
endpoints: non-inferiority of SPI vs. iDose⁴ for image quality and diagnostic confidence in both conventional and spectral images; comparison of SPI spectral images to iDose⁴ conventional images; performance in chest high-resolution scans; success rate; reader agreement
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 matches this device's applicant.
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 matches this device's applicant.
first seen 2026-07-08 · recall res_event_number:98588
- 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 matches this device's applicant.
first seen 2026-07-08 · recall res_event_number:97699
- 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 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).