Precise Image
K210760Philips Medical Systems Nederland, B.V. · cleared 2022-01-14 · product code JAK · Radiology
Premarket evidence — what FDA accepted
source quote (p.3)
“The Precise Image is a reconstruction software application for a Computed Tomography X-Ray System intended to produce images of the head and body by computer reconstruction of x-ray transmission data taken at different angles and planes.”
source quote (p.3)
“Precise Image uses an Artificial Intelligence powered reconstruction algorithm that is designed for low radiation dose, provides lower noise, and improves low contrast detectability. Precise Image is a robust reconstruction software application, utilizing technological advancements in Artificial Intelligence and a Convolutional Neural Networks (CNN)”
source quote (p.7)
“Proposed Regulatory Framework for Modifications to Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD) Discussion Paper. (April 2, 2019)”
Validation studies (2)
Bench
sample size not stated
endpoints: Low Contrast Resolution; Noise in Standard Mode; Noise Reduction and Low Contrast Detectability; Noise Power Spectrum
standards: IEC 60601-1:2005 (Third Edition) + CORR. 1:2006 + CORR. 2:2007 + A1:2012 (or IEC 60601-1: 2012 reprint), IEC 60601-1-2:2014, IEC 60601-1-3:2008+A1:2013, IEC 60601-1-6:2010 +A1: 2013, IEC 60601-2-44:2009/AMD2:2016, IEC 62304:2006 + A1: 2015, ISO 10993-1:2009/Cor.1:2010, ISO 14971 2nd Edition., Guidance for Industry and FDA Staff – Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, International and FDA-recognized consensus IEC 62304 “Medical device software – Software life cycle processes”, Proposed Regulatory Framework for Modifications to Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD) Discussion Paper.
Reader study (MRMC)
n=55 images
endpoints: Diagnostic Confidence; Sharpness; Noise level; Image texture; Artifacts on a five point Likert scale
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 (Philips Medical Systems Nederland B.V. Veenpluis, initiated 2025-02-28): "Multiple problems identified with the software version leading to various scanning and image issues, and unintended device movement." Recalling firm matches this device's applicant.
first seen 2026-07-08 · recall res_event_number:96423
- 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
- …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).