FDA-approved P130020/S005

Senographe Pristina 3D

GE Healthcare

Senographe Pristina 3D PMA supplement S005 updates digital breast tomosynthesis reconstruction with deep learning to correct sparse-view artifacts, compensate patient motion, and...

Modality
Mammography/DBT
Anatomy
Breast
Decision
2025-11-21
FDA-cleared K242925

MR Contour DL

GE HealthCare

MR Contour DL generates DICOM RT Structure Sets with initial organ-at-risk contours from adult MR images to accelerate radiation-treatment planning; users must verify, correct,...

Modality
Radiotherapy Planning Imaging
Anatomy
Adult anatomy represented by organs at risk on MR images
Decision
2025-04-01
FDA-cleared K223212

Precision DL

GE Healthcare

Precision DL uses deep-learning image processing to enhance non-time-of-flight F-18 FDG PET images for clinical oncology review in adults and children.

Modality
PET/SPECT/Nuclear Medicine
Anatomy
Multi-region
Decision
2023-04-27
FDA-cleared K221680

Xeleris V Processing and Review System

GE Healthcare

The Xeleris V Processing and Review System displays, processes, archives, prints, reports, and networks planar, SPECT, and PET nuclear-medicine data, with optional applications...

Modality
PET/SPECT/Nuclear Medicine
Anatomy
Whole body, lung, brain, liver, cardiac, coronary, and other anatomy represented in labeled nuclear-medicine studies
Decision
2023-03-01
FDA-cleared K213689

Voluson P6, Voluson P8

GE Healthcare

Voluson P6 and Voluson P8 are general-purpose diagnostic ultrasound systems for qualified healthcare professionals across the labeled fetal, obstetric, abdominal, gynecologic,...

Modality
Ultrasound
Anatomy
Fetus; abdomen; pelvis; small organs; head; heart; peripheral vessels; musculoskeletal; and urologic anatomy
Decision
2022-02-17
FDA-cleared K201103

Xeleris V Processing and Review Systems

GE Healthcare

Xeleris V is intended for nuclear-medicine or radiology practitioners and referring physicians to display, process, archive, print, report, and network nuclear-medicine data from...

Modality
PET/SPECT/Nuclear Medicine
Anatomy
Whole-body, lung, brain/striatum, and other anatomy represented in nuclear-medicine, PET, CT, and MR studies
Decision
2020-09-25
FDA-cleared K182419

Centricity Universal Viewer

GE Healthcare

Centricity Universal Viewer displays, communicates, stores, and processes supported medical images and related data for authorized users in clinical imaging workflows;...

Modality
Radiological images; modality varies or is not specified in FDA list
Anatomy
Multi-region
Decision
2018-12-14