CL24N
CL24N is a 2.1-megapixel color LCD medical monitor for displaying high-resolution color and grayscale medical images in PACS and radiology systems. The filing describes it as a display and…
inHEART Models Explorer
inHEART Models Explorer is a a web-based 3D visualization software that permits display, review, analysis, annotation and export of the cardiac 3D models generated from inHEART MODELS…
NuVEIW
The NuVIEW® is a mobile visualization platform tailored for use with a C-arm and Patient Monitor in Minimally Invasive Surgery suites, Ambulatory Surgery Centers, Urology, GI and other…
Affiniti 30 Diamond Select Ultrasound System
Catalogue number 795121, listed by Philips Ultrasound LLC, United States, under System, Image Processing, Radiological. 16 manufacturers in China are registered for this product code.
Grin Website
Catalogue number Initial Release, listed by GET-Grin Inc, United States, under System, Digital Image Communications, Radiological. 6 manufacturers in China are registered for this product code.
Codonics Virtua® Controller – 75c
Virtua DICOM Server/Publisher Controller -75C
Device, Digital Image Storage, Radiological
Medicap USB200 Digital REC
SW-Key: Nmg_scenium_spect
Catalogue number 08716669, listed by Siemens Medical Solutions USA, Inc., United States, under System, Image Processing, Radiological. 16 manufacturers in China are registered for this product code.
Elucis
Elucis is a software system for creating, visualizing and interacting with three-dimensional anatomical models from medical images. The FDA summary describes desktop and extended-reality…
Vitrea Enterprise Viewer
VitreaView is a cross-browser, cross-platform, zero-footprint universal medical image viewer solution capable of displaying both DICOM and non-DICOM medical images for diagnosis, review,…
EzMobile
EzMobile is dental imaging software that is intended to provide diagnostic tools for maxillofacial radiographic imaging. These tools are available to view and interpret a series of DICOM…
Epiq 7 Diamond Select Ultrasound System
Catalogue number 795117, listed by Philips Ultrasound LLC, United States, under System, Image Processing, Radiological. 16 manufacturers in China are registered for this product code.
Scenium Suite_V
Catalogue number 10183312, listed by Siemens Medical Solutions USA, Inc., United States, under System, Image Processing, Radiological. 16 manufacturers in China are registered for this product code.
Vidar Systems Corporation
10 catalogue numbers from DosimetryPRO Advantage, Red Illumination, listed by Vidar Systems Corp., United States, under Digitizer, Image, Radiological. 1 manufacturer in China is registered for this product code.
X-PSI™ Persona®
Catalogue number 20-8085-001-02, listed by Orthosoft, Inc., Canada, under System, Image Processing, Radiological. 16 manufacturers in China are registered for this product code.
PowerLook MammoAI Container – Sectra
Catalogue number DSC026-01, listed by Icad Inc., United States, under System, Digital Image Communications, Radiological. 6 manufacturers in China are registered for this product code.
NM Suite
The NM Suite is a nuclear medicine image display and processing application suite that provides software applications used to process, analyze, and display medical images and data.
CS Orthodontic Imaging Software
CS Orthodontic Imaging Software stores, displays and annotates dental images for orthodontic practices. It interfaces with compatible imaging equipment to acquire radiographs of the teeth…
Change Healthcare Stratus Imaging PACS
16 catalogue numbers from 1.4.8, listed by Change Healthcare Canada Company, Canada, under System, Image Processing, Radiological. 16 manufacturers in China are registered for this product code.
VEA Portal
Catalogue number 1.0, listed by EOS imaging, France, under System, Digital Image Communications, Radiological. 6 manufacturers in China are registered for this product code.
Segment 3DPrint
Segment 3DPrint: 1 catalogue number listed by Medviso AB, Sweden, under System, Image Processing, Radiological. 16 manufacturers in China are registered for this product code.
All-in-One Clinic Viewer
SuRgical Planner (SRP) Clinic Viewer Desktop
PowerLook AMP With Density Assessment GE US
Catalogue number DSC012-02, listed by Icad Inc., United States, under System, Image Processing, Radiological. 16 manufacturers in China are registered for this product code.
SubtleALIGN
SubtleALIGN is a radiology image reformatting software that is intended to automatically align 3-dimensional brain MR images to consistent anatomical orientations (axial, coronal, and…
Exo Works
Catalogue number EW1001, listed by Exo Imaging, Inc., United States, under System, Digital Image Communications, Radiological. 6 manufacturers in China are registered for this product code.
Drgem
Catalogue number GEMPACS, listed by Drgem Corporation, South Korea, under System, Digital Image Communications, Radiological. 6 manufacturers in China are registered for this product code.
Dbswin 5.11.0
Catalogue number E7200, listed by Dürr Dental SE, Germany, under System, Image Processing, Radiological. 16 manufacturers in China are registered for this product code.
CT Perfusion
CT Perfusion V1.0 is an automatic calculation tool indicated for use in radiology. The device is an image processing software allowing computation of parametric maps from CT Perfusion data…
ClearRead CT
ClearRead CT on Docker Platform
Vitrea Software Toshiba Package
This device was previously sold by TOSHIBA MEDICAL SYSTEMS CORPORATION under the brand name Vitrea Software Toshiba Package. Effective Jan 2018, the company name changed to CANON MEDICAL…
Mammovista B.smart
Medical software that provides workflow, reading and reporting support on clinical images
PowerLook AMP With Density Assessment GE OUS
Catalogue number DSC012-03, listed by Icad Inc., United States, under System, Image Processing, Radiological. 16 manufacturers in China are registered for this product code.
BriefCase Triage
BriefCase Triage is radiological computer-aided triage and notification software. It analyzes medical images to identify or prioritize cases for time-sensitive review and sends a…
ElucidPlaqueIQ
Elucid PlaqueIQ is a cloud-based image analysis software package, that will be applied to Computed Tomography (CT) images that allows Elucid to process acquired image data. The package…
DeepContour
DeepContour is a deep learning based medical imaging software that allows trained healthcare professionals to use DeepContour as a tool to automatically process CT images.
PowerLook PRO+ Rack-Mount, OUS
2 catalogue numbers from DSC034-01, DSC034-02, DSC034-03, listed by Icad Inc., United States, under System, Digital Image Communications, Radiological. 6 manufacturers in China are registered for this product code.
Dental Imaging Software
Catalogue number Dental Imaging Software, listed by Carestream Dental LLC, United States, under System, Image Processing, Radiological. 16 manufacturers in China are registered for this product code.
Mimics Automatic Algorithms
Mimics Automatic Algorithms CMF Reconstruction CT CBCT
Sicat Implant
4 catalogue numbers from V2.0.40, listed by Sicat Gmbh & Co. KG, Germany, under System, Image Processing, Radiological. 16 manufacturers in China are registered for this product code.
Blackford Smart Localizer
Blackford Smart Localizer v1.4.x, supplied with Blackford Platform (part of the Blackford Product Family)- previously marketed as the Blackford Registration Application, released under…
IB Clinic
2 catalogue numbers from 2.0, listed by Imaging Biometrics, LLC, United States, under System, Image Processing, Radiological. 16 manufacturers in China are registered for this product code.
OPSInsight™
OPSInsight™ is intended for use as preoperative surgical planning software to aid orthopaedic surgeons in component selection, sizing and placement for primary total hip arthroplasty.
CA1000
Catalogue number 2.0 SP 14, listed by GE Healthcare GmbH, Germany, under System, Image Processing, Radiological. 16 manufacturers in China are registered for this product code.
Move Forward Report 1-3
Catalogue number CG001, listed by Biomet Orthopedics, United States, under System, Image Processing, Radiological. 16 manufacturers in China are registered for this product code.
Trophy 3d Imaging
Catalogue number Trophy 3D Imaging, listed by Carestream Dental LLC, United States, under System, Image Processing, Radiological. 16 manufacturers in China are registered for this product code.
MammoScape
EDIT 2025-11: MeVis BreastCare GmbH & Co. KG ceased to exist on 2025-11-01; legal successor is MeVis Medical Solutions AG (DUNS:…
OptiVu™ Mixed Reality
2 catalogue numbers from OVMR-SW-2-0201, listed by Orthosoft, Inc., Canada, under System, Image Processing, Radiological. 16 manufacturers in China are registered for this product code.
Showcase®
ShowCase Viewer for iPad is a DICOM medical image viewer for the Apple iPad. ShowCase Viewer for iPad is not intended for diagnostic use.
Full Face Sim Model
Patient-specific, full-face 3D printed anatomic model depicting a patient’s treatment plan. Non-diagnostic. RX only.
MIMviewer
A medical image software package that aids the physician in the diagnosis of patients by means of medical images. It is a DICOM viewer used to display, register and fuse medical images from…
sUSBA Software
Catalogue number 11149925, listed by Siemens Medical Solutions USA, Inc., United States, under System, Image Processing, Radiological. 16 manufacturers in China are registered for this product code.
Merge Iconnect Access
Software application that provides internet access to multi-modality softcopy medical images, reports and other patient related information for conducting diagnostic review, planning, and…
MinXray
This device is intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic x-rays. Not for mammographic use. This device is a…
V3D-Vascular
V3D-Vascular is a software application used with advanced PC hardware for evaluating scanned images of selected vessels. It is designed to aid the physician in analyzing the vascular system…
Biim Android App, P1.2
Catalogue number P001158, listed by Biim Ultrasound AS, Norway, under System, Image Processing, Radiological. 16 manufacturers in China are registered for this product code.
Change Healthcare Stratus Imaging Diagnostic Viewer
3 catalogue numbers from 2.9, listed by Change Healthcare Canada Company, Canada, under System, Image Processing, Radiological. 16 manufacturers in China are registered for this product code.
SwiftSight-Brain
SwiftSight-Brain analyzes MRI images to label brain structures and lesions and measure their volumes. It produces segmented images with coloured overlays and reports that organize the…
syngo.MR Cardiology
2 catalogue numbers from 11234871, listed by Siemens Healthcare Limited, Canada, under System, Image Processing, Radiological. 16 manufacturers in China are registered for this product code.
FRU, PowerLook 10 PRO+
Catalogue number D4D0223, listed by Icad Inc., United States, under System, Digital Image Communications, Radiological. 6 manufacturers in China are registered for this product code.
JiveX
Version 5.4+ includes all minor versions and patch levels of 5.4 as well as higher versions (e.g. 5.5) in case no new 510(k) submission is needed.
True 3d Viewer
Software: The True 3D Viewer Software is intended for processing, review, analysis, communication and media interchange of digital images acquired from CT, MRI and Ultrasound sources. It is…
HipCheck
Catalogue number 01030300, listed by Stryker GmbH, Switzerland, under Automated Radiological Image Processing Software. 8 manufacturers in China are registered for this product code.
EchoGo
The FDA filing identifies EchoGo Core as software for quantifying and reporting cardiovascular function to support physician diagnosis. It is indicated for adults. The summary describes a…
Xeleris Processing and Review Workstation
Xeleris V Clinical Application SW
Codonics Horizon® Ci Multi-Media Imager
Grayscale/Color Desktop Ci Format Film and Paper Diagnostic Imager
EasyViz
EasyViz is a software only medical device providing tools and features that may be used for general-purpose radiological viewing and reading (diagnosis) of image data from various imaging…
Biim Android App, P1.1
Catalogue number P001118, listed by Biim Ultrasound AS, Norway, under System, Image Processing, Radiological. 16 manufacturers in China are registered for this product code.
Sirona Medical Radiology Platform
Catalogue number Model1, listed by Sirona Medical, Inc., United States, under System, Digital Image Communications, Radiological. 6 manufacturers in China are registered for this product code.
Synapse MPR Fusion
Synapse MPR/Fusion software enables the display, comparison and fusion of 3D (MIP/MPR) of CT, MR, PET and SPECT studies. Typical users are radiologists, technologists and clinicians.…
ClariCT.AI
ClariCT.AI, is a software device intended for networking, communication, processing and enhancement of CT images in DICOM format regardless of the manufacturer of CT scanner or model. The…
Drypix Plus
The Fuji Medical Dry Laser Imager DRYPIX 4000 is a device that prints digital image data, transferred via the DICOM network from the FCR Image Reader or CT, MRI and other imaging…
Transpara
Transpara Density is software for use with compatible digital mammography and digital breast tomosynthesis data. The FDA filing describes it as an optional feature of Transpara. It…
eRAD PACS Evolution
Catalogue number 8.0, listed by Erad, Inc., United States, under System, Image Processing, Radiological. 16 manufacturers in China are registered for this product code.
Curve Hero™
Curve Dental® develops and markets a cloud-based dental practice management system titled Curve Hero™. Using a Mac or PC platform, a dental practice can use Curve Hero™ to manage all…
DTX Studio™ Diagnose
DTX Studio diagnose displays and processes images used in dental and cranio-maxillofacial diagnosis. It supports two- and three-dimensional image information, including cone-beam CT,…
Imbio PHA
The PHA Software is a set of medical image post-processing computer algorithms that together perform automated image segmentation and diameter measurements on computed tomography pulmonary…
HipMap Femoroacetabular Impingement Analysis
Catalogue number 3105001000, listed by Stryker GmbH, Switzerland, under Automated Radiological Image Processing Software. 8 manufacturers in China are registered for this product code.
40005 PercuNav Coaxial Needle Tracker, 18g X 8 Cm
Catalogue number 989605428024, listed by Philips Ultrasound LLC, United States, under System, Image Processing, Radiological. 16 manufacturers in China are registered for this product code.
ORS Visual
ORS Visual is a proprietary software application developed by Object Research Systems (ORS) Inc. that can be is used for the display and 3D visualization of medical image data derived from…
DynaLOC Breast Interventional Planning Software
The DynaLOC Breast Interventional Planning software module supports the use of MR interventional breast coils and localization devices to perform MR-guided breast interventional procedures.…
e-MRI
5 catalogue numbers from 11.1, listed by Brainomix Limited, United Kingdom, under System, Image Processing, Radiological. 16 manufacturers in China are registered for this product code.
3D/5D Viewer
Samsung 3D/5D Viewer is desktop software for reviewing three-dimensional ultrasound volume data away from the scanner. It lets a clinician display, analyze, edit, measure and store datasets…
Invivo
UroNav is a medical image processing device that provides image-guided intervention and diagnostic information, which guides interventional instrumentation to targets that have been defined…
Preview® Treatment Planning Software
Catalogue number 10.0.0, listed by Astute Imaging Inc, United States, under System, Image Processing, Radiological. 16 manufacturers in China are registered for this product code.
Syngo.interventional
syngo.Interventional VB40; Medical Device syngo.Interventional VB40 is covered by NFJ to K190780 syngo Application Software VE20
I-Rapha Solution
i-Rapha Solution is browser based software for receiving, storing and viewing DICOM medical images. Its i-Rapha View component displays diagnostic quality images and supports image review…
Breastscape
breastscape V1.0 is an optional image processing software application that is intended for use on Olea Sphere V3.0 software package cleared under K152602. It is intended to be used by…
System, Image Processing, Radiological
SFW KIT 9734400 StealthMerge ENT WITH PG
X-PSI™
5 catalogue numbers from 20-8017-036-00, listed by Orthosoft, Inc., Canada, under System, Image Processing, Radiological. 16 manufacturers in China are registered for this product code.
MeVis AVM Contour
MeVis AVM Contour supports visualization and contouring of 3D CT-based structures for arteriovenous malformation treatment planning. The software exports contours in DICOM RT Structure Set…
AiORTA – Plan
AiORTA - Plan is cloud-based software for geometric assessment of abdominal aortic aneurysms using CT angiography data. It calculates measurements for preoperative evaluation, intervention…
Spectral Bone Marrow
Spectral Bone Marrow MD Application Container for Smart Subscription
Sicat Air
Catalogue number 6543651, listed by Hicat GmbH, Germany, under System, Image Processing, Radiological. 16 manufacturers in China are registered for this product code.
Syngo Application Software
Catalogue number 11831234, listed by Siemens Healthcare Limited, Canada, under Automated Radiological Image Processing Software. 8 manufacturers in China are registered for this product code.
PowerLook PRO+ Hardware Platform GE, US
Catalogue number DSC018-04, listed by Icad Inc., United States, under System, Digital Image Communications, Radiological. 6 manufacturers in China are registered for this product code.
IntelliSpace PACS Anywhere
IntelliSpace PACS Anywhere enhances the IntelliSpace PACS product portfolio by providing the ability for clinicians and administrators to access patient information, images and diagnostic…
Olea Sphere
Olea Sphere V3.0 is an image processing software package to be used by trained professionals including but not limited to physicians and medical technicians. The software runs on a standard…
Overjet Cbct Assist
Overjet CBCT Assist is cloud-based software for reviewing dental and craniomaxillofacial cone-beam CT images. It provides volume rendering and multiplanar views with manual and automated…
5d Viewer
Samsung 5D Viewer is computer software for reviewing and measuring three-dimensional ultrasound volume data away from the ultrasound console. It uses compatible volume files exported from…
IB Lab Lama
IB Lab LAMA automatically measures lower-limb lengths and knee alignment on unilateral or bilateral anteroposterior full-leg radiographs. It assists radiology-trained healthcare…
Scenium Spect MI Mobile Bundle
Catalogue number 10183756, listed by Siemens Medical Solutions USA, Inc., United States, under System, Image Processing, Radiological. 16 manufacturers in China are registered for this product code.
Chrome
The iCRco Chrome LF is a high-resolution, tabletop computed radiography (CR) system designed for general digital radiography and orthopedic imaging. It utilizes a patented True Flat Scan…
Merge Cardio
Merge Cardio is a software medical device that is an integrated multi-modality image cardiovascular information management system. The Merge Cardio system is intended to allow authorized…