AI Devices

Reconstruction & enhancement

Radiology AI devices in the Reconstruction & enhancement category, FDA-cleared or EU CE-marked, newest clearance first. Information only, never clinical advice.

US

syngo.via MI Workflows; Scenium; syngo MBF

🇺🇸Siemens Medical Solutions USA, Inc.

MR image reconstruction/enhancement

MRReconstruction & enhancement510(k) 2025
US

Bunkerhill Abdominal Aortic Quantification (AAQ)

🇺🇸BunkerHill Health

MR image reconstruction/enhancement

MRReconstruction & enhancement510(k) 2025
US

PIUR tUS inside

🇦🇹PIUR Imaging GmbH

MR image reconstruction/enhancement

MRReconstruction & enhancement510(k) 2025
US

Synapse PACS (7.5)

🇺🇸FUJIFILM Healthcare Americas Corporation

MR image reconstruction/enhancement

MRReconstruction & enhancement510(k) 2025
US

EchoConfidence (USA)

Mycardium AI Limited

MR image reconstruction/enhancement

MRReconstruction & enhancement510(k) 2025
US

Brainlab Elements (7.0); Brainlab Elements Image Fusion (5.0); Brainlab Elements Image Fusion Angio (1.0); Brainlab Elements Contouring (5.0); Brainlab Elements Fibertracking (3.0); Brainlab Elements BOLD MRI Mapping (1.0)

🇩🇪Brainlab AG

MR image reconstruction/enhancement

MRReconstruction & enhancement510(k) 2025
US

Viz Subdural+, Viz SUBDURAL PLUS

🇺🇸Viz.ai, Inc.

MR image reconstruction/enhancement

MRReconstruction & enhancement510(k) 2025
US

Cirrus Resting State fMRI Software

Sora Neuroscience, Inc.

MR image reconstruction/enhancement

MRReconstruction & enhancement510(k) 2025
US

BrightHeart View Classifier

🇫🇷Brightheart

MR image reconstruction/enhancement

MRReconstruction & enhancement510(k) 2025
US

TraumaCad Neo (1.1)

🇮🇱Brainlab Ltd.

MR image reconstruction/enhancement

MRReconstruction & enhancement510(k) 2025
US

AudaxCeph Cephalogram Analysis Software

Audax d.o.o.

MR image reconstruction/enhancement

MRReconstruction & enhancement510(k) 2025
US

Opulus™ Lymphoma Precision

🇺🇸Roche Molecular Systems, Inc.

MR image reconstruction/enhancement

MRReconstruction & enhancement510(k) 2025
US

CoLumboX

Smart Soft Healthcare AD

MR image reconstruction/enhancement

MRReconstruction & enhancement510(k) 2025
US

Rapid MLS

🇺🇸iSchemaView, Inc.

MR image reconstruction/enhancement

MRReconstruction & enhancement510(k) 2025
US

Clever One

🇰🇷Ewoosoft Co., Ltd

MR image reconstruction/enhancement

MRReconstruction & enhancement510(k) 2025
US

Second Opinion® 3D

🇺🇸Pearl, Inc.

MR image reconstruction/enhancement

MRReconstruction & enhancement510(k) 2025
US

Synapse 3D Base Tools (V7.0)

🇯🇵Fujifilm Corporation

MR image reconstruction/enhancement

MRReconstruction & enhancement510(k) 2025
US

Medical Image Post-processing Software (uOmnispace.CT)

🇨🇳Shanghai United Imaging Healthcare Co., Ltd.

MR image reconstruction/enhancement

MRReconstruction & enhancement510(k) 2025
US

Second Opinion® BLE

🇺🇸Pearl, Inc.

MR image reconstruction/enhancement

MRReconstruction & enhancement510(k) 2025
US

Clarius Median Nerve AI

🇨🇦Clarius Mobile Health Corp.

MR image reconstruction/enhancement

MRReconstruction & enhancement510(k) 2025
US

BrightHeart View Classifier

🇫🇷Brightheart

MR image reconstruction/enhancement

MRReconstruction & enhancement510(k) 2025
US

UltraExtend NX CUW-U001S V2.0 Ultrasound Image Analysis Program

🇯🇵Canon Medical Systems Corporation

MR image reconstruction/enhancement

MRReconstruction & enhancement510(k) 2025
US

LARALAB

LARALAB GmbH

MR image reconstruction/enhancement

MRReconstruction & enhancement510(k) 2025
US

Clarius Prostate AI

🇨🇦Clarius Mobile Health Corp.

MR image reconstruction/enhancement

MRReconstruction & enhancement510(k) 2025
US

GBrain MRI

Galileo CDS, Inc

MR image reconstruction/enhancement

MRReconstruction & enhancement510(k) 2025
US

cmAngio® (V1.6)

🇺🇸CureMetrix, Inc.

MR image reconstruction/enhancement

MRReconstruction & enhancement510(k) 2025
US

DeepFoqus (DeepFoqus-Accelerate)

Foqus Technologies Inc.

MR image reconstruction/enhancement

MRReconstruction & enhancement510(k) 2025
US

syngo Dynamics (Version VA41D)

🇩🇪Siemens Healthcare GmbH

MR image reconstruction/enhancement

MRReconstruction & enhancement510(k) 2025
US

Hi-D Imaging 4TAVR

Hi-D Imaging AG

MR image reconstruction/enhancement

MRReconstruction & enhancement510(k) 2025
US

TribusConnect

TribusMed Beheer BV

MR image reconstruction/enhancement

MRReconstruction & enhancement510(k) 2025
NewerPage 3 of 10Older