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FDA-cleared K253614

EchoNavigator R5.0

Philips Medical Systems Nederland B.V.

Authorized purpose: EchoNavigator R5.0 supports an interventionalist or surgeon during cardiovascular treatment by combining live X-ray and live echocardiographic information.

Modality
Fluoroscopy/Angiography
Anatomy
Heart and cardiovascular structures
Decision
2026-03-17
FDA-cleared K260169

AV Cardiac CT

Philips Medical Systems Nederland B.V.

Authorized purpose: AV Cardiac CT assists radiologists, cardiologists and 3D technologists with viewing, processing and analysis of gated cardiac CT data, including coronary anatomy and cardiac function, to prepare cardiac interventions; physician review and decisions remain required.

Modality
CT/CTA
Anatomy
Heart/Cardiovascular
Decision
2026-03-05
FDA-cleared K253648

Ingenia, Ingenia CX, Ingenia Elition S/X, Ingenia Ambition S/X, BlueSeal SE/XE/QE, MR 5300 and MR 7700 MR Systems including Upgrades

Philips Medical Systems Nederland B.V.

Authorized purpose: The Ingenia, Ingenia CX, Elition, Ambition, BlueSeal, MR5300, and MR7700 systems produce diagnostic MR images, spectra, and physical parameters of the head, body, and extremities for trained physician interpretation.

Modality
MRI
Anatomy
Head, body, and extremities
Decision
2026-02-23
FDA-cleared K253735

AV Vascular

Philips Medical Systems Nederland B.V.

Authorized purpose: AV Vascular assists trained healthcare professionals with visualization, assessment, and quantification of vascular anatomy on CTA and/or MRA for suspected or diagnosed vascular pathology and pre-procedural endovascular planning.

Modality
Radiological images; modality varies or is not specified in FDA list
Anatomy
Vascular anatomy; head/neck, body, aorta, iliac and subclavian vessels
Decision
2026-01-22
FDA-cleared K213583

Achieva, Ingenia, Ingenia CX, Ingenia Elition and Ingenia Ambition MR Systems

Philips Medical Systems Nederland B.V.

Authorized purpose: The Philips Achieva, Ingenia, Ingenia CX, Ingenia Elition, and Ingenia Ambition MR systems provide head, body, and extremity MRI, with SmartSpeed AI deep-learning acceleration in supported configurations.

Modality
MRI
Anatomy
Multi-region
Decision
2022-05-16
FDA-cleared K210760

Precise Image

Philips Medical Systems Nederland, B.V.

Precise Image is an adult head-and-body CT reconstruction application for selected Philips Incisive CT protocols that uses a convolutional neural network to reduce noise and improve low-contrast detectability while preserving a familiar filtered-back-projection-like appearance; it is not indicated for pediatric patients.

Modality
CT/CTA
Anatomy
Multi-region
Decision
2022-01-14
FDA-cleared K211764

Vereos PET/CT

Philips Medical Systems Nederland B.V.

Authorized purpose: Vereos PET/CT detects, localizes, diagnoses, stages, restages, and follows treatment response in oncology, cardiology, and neurology and can provide diagnostic CT and radiotherapy-planning support; optional PET Adaptive Reconstruction is an AI-powered image-reconstruction function.

Modality
PET/SPECT/Nuclear Medicine
Anatomy
Multi-region
Decision
2021-08-06