ClearanceBrief
Panels › Radiology › Product code LLZ · Class 2

System, Image Processing, Radiological

Regulation 892.2050

48510(k)s in 12 months (2,293 all time)
24recalls in 12 months (561 all time)
543recalls that name a 510(k)
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Top companies in LLZ

DateFirm and productCodeLinked 510(k)
Oct 15, 2026INTELERAD MEDICAL SYSTEMS INCORPORATED
IntelePACS, InteleConnect Portal/Tech Portal Versions PACS-5-1-1-R102, PACS-5-2-1-R93, PACS-5-3-1-R83 through R128, PACS-5-4-1-R66 through R101, PACS-5-5-1-R50 through R89, PACS-5-6-1-R41 through R81,
Open, Classified
LLZK192176
Sep 15, 2026GE Healthcare
Core Services Hub V8, a set of backend services including Cross Enterprise (XE) and Workflow Core (WFC) services that enables enterprise imaging workflows, All versions
Open, Classified
LLZK043415
K110875
Sep 15, 2026GE Healthcare
Workflow Core Services V8, intended to provide set of services for storage and retrieval of patient data, exams and performs system Administration, common configuration management for consuming applic
Open, Classified
LLZK043415
K110875
Sep 15, 2026GE Healthcare
Centricity PACS Server V7, intended for managing digital medical images and associated data, All versions
Open, Classified
LLZK043415
K110875
Sep 15, 2026GE Healthcare
Centricity PACS V2, V3, V4, V6, V7, software product is intended for the storage, reading, diagnostic review, analysis, annotation, distribution, printing, editing, and processing of digital images an
Open, Classified
LLZK043415
K110875
Sep 15, 2026GE Healthcare
Enterprise Archive V8, software product for receiving, archiving, and sending electronic medical data, All versions
Open, Classified
LLZK043415
K110875
Sep 15, 2026GE Healthcare
Centricity Enterprise Archive V2, V3, and V4, software product for receiving, archiving, and sending electronic medical data, All Versions
Open, Classified
LLZK043415
K110875
Aug 26, 2026FUJIFILM Healthcare Americas Corporation
FUJIFILM Synapse PACS software v7.4.310; radiological image processing system
Open, Classified
LLZK190232
Aug 21, 2026Merge Healthcare, Inc.
Merge PACS and Merge OrthoPACS, medical imaging diagnostic workstation
Open, Classified
LLZK192455
Aug 4, 2026Merge Healthcare, Inc.
Merge OrthoPACS, medical imaging diagnostic workstation
Open, Classified
LLZK192455
Aug 4, 2026Merge Healthcare, Inc.
Merge PACS, medical imaging diagnostic workstation
Open, Classified
LLZK192455
Jul 22, 2026Boston Scientific Corporation
Boston Scientific TheraSphere 360 Y-90 Management Platform, Model Number M00139509001; Radiological Image Processing System.
Open, Classified
LLZK252547
K260479
Jun 24, 2026GE Medical Systems SCS
GE Healthcare AW Server 3.2 ext.6.5; Radiological Image Processing System
Open, Classified
LLZK081985
May 6, 2026Mint Medical GmbH
Mint Lesion; Software Versions: 3.4.0 up to 3.9.5.;
Open, Classified
LLZK142647
Apr 10, 2026PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Philips AneurysmFlow. Model Number: 001015. AneurysmFlow is a software medical device (Interventional Tool) intended to be used in combination with a Philips interventional X-ray system and 3DRA dat
Open, Classified
LLZK160455
Mar 27, 2026PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Vue Motion V12. Product Number: 1017979.
Open, Classified
LLZK151774
Mar 16, 2026GE Medical Systems, LLC
Centricity Universal Viewer Software Versions 5.0 SP6 through UV 5.0 SP7.1, a device that displays medical images (including mammograms) and data from various imaging sources, Model Numbers 2088026-02
Open, Classified
LLZK123174
Mar 16, 2026GE Medical Systems, LLC
Centricity Universal Viewer Software Versions 6.0 through 6.0 Sp10.4.1, a device that displays medical images (including mammograms) and data from various imaging sources, Model Numbers 2088026-406, 2
Open, Classified
LLZK150420
Mar 16, 2026GE Medical Systems, LLC
Centricity Universal Viewer Software Versions 7.0 through 7.0 Sp2.0.1, a device that displays medical images (including mammograms) and data from various imaging sources, Model Numbers 5826659-027, 58
Open, Classified
LLZK182419
Feb 27, 2026GE Healthcare
GE Healthcare Centricity Universal Viewer Zero Footprint Client, Model Numbers: 2110344-039, 2110344-046, 2110344-047; System, Image Processing, Radiological
Open, Classified
LLZK131977
Feb 3, 2026Focalyx Technologies, LLC.
Focalyx Fusion
Open, Classified
LLZK170250
Dec 18, 2025DICOM Grid, Inc.
Intelerad InteleShare software, with ProViewer component
Open, Classified
LLZK231360
Dec 16, 2025GE Healthcare GmbH
GE HealthCare ViewPoint 6, Catalog Number H47601AA; Radiological image processing system
Open, Classified
LLZK241300
Nov 26, 2025INTELERAD MEDICAL SYSTEMS INCORPORATED
IntelePACS - InteleConnect / TechPortal
Open, Classified
LLZK192176
Oct 24, 2025Surgical Theater Inc
Surgical Planner, BrainSTORM, software version BST.9.3.0, orthopedic augmented reality
Terminated
LLZK201465
Oct 24, 2025Surgical Theater Inc
Endo Surgical Navigation Advanced Platform Patient Engagement (EndoSNAP), software version SNP.1.12.0, imaging processing radiological system
Terminated
LLZK160584
Oct 24, 2025Surgical Theater Inc
SyncAR Surgical Navigation Advanced Platform Patient Engagement (SyncAR SNAP), software version SNP.1.12.0, imaging processing radiological system
Terminated
LLZK160584
Oct 24, 2025Surgical Theater Inc
Surgical Navigation Advanced Platform Patient Engagement (PE SNAP), software version SNP.3.12.0, imaging processing radiological system
Terminated
LLZK160584
Oct 24, 2025Surgical Theater Inc
Surgical Navigation Advanced Platform (SNAP), software version SNP.3.12.0, imaging processing radiological system
Terminated
LLZK160584
Oct 24, 2025Surgical Theater Inc
SuRgical Planner (SRP), software version SRP.7.12.0, imaging processing radiological system
Terminated
LLZK170793
Oct 8, 2025GE Medical Systems, SCS
AW Server 2.0, AW Server 3.0, AW Server 3.1, AW Server 3.2
Open, Classified
LLZK081985
Oct 2, 2025CHANGE HEALTHCARE CANADA COMPANY
Change Healthcare Radiology Solutions software version 14.2.2
Open, Classified
LLZK140909
Sep 9, 2025Philips Medical Systems Nederland B.V.
IntelliSpace Cardiovascular, Software 8.0.0.4.
Open, Classified
LLZK153022
Aug 12, 2025PIE Medical Imaging B.V.
3mensio Workstation (Vascular Fenestrated) software
Open, Classified
LLZK153736
May 21, 2025Echopixel, Inc.
TRUE 3D VIEWER SYSTEM Model Number EP-00001-XX Software versions 1.0, 1.25, and 1.35 The t3D-Viewer is designed for use by health care professionals HCPs and is intended to assist the clinician who
Open, Classified
LLZK142107
May 16, 2025Echopixel, Inc.
True 3D Viewer, Model: EP-00003
Open, Classified
LLZK170167
May 8, 2025Philips Medical Systems Nederland B.V.
IntelliSpace Cardiovascular software versions 6.x, 7.x, and 8.x; Model Number: 830089.
Open, Classified
LLZK153022
Mar 28, 2025GE Healthcare
GE Healthcare Centricity Centricity PACS-IW with Universal Viewer, Model Numbers: 1) 2049587-015; 2) 2066908-086; 3) 2066908-136; 4) 2104867-045.
Open, Classified
LLZNone listed
Mar 28, 2025GE Healthcare
GE Healthcare Centricity Cardiology CA1000 (CA1000), Model Numbers: 1) 2033901-001; 2) 2038437-001; 3) 2038437-009; 4) 2038437-014; 5) 2038437-015 ; 6) 2038437-0XX; 7) 2109571-007; 8) 2109571
Open, Classified
LLZK042525
K063628
Mar 28, 2025GE Healthcare
GE Healthcare Centricity Radiology RA600 (RA600), Model Numbers: 1) 2022296-001; 2) 2033901-001; 3) 2038437-001; 4) 2038437-011; 5) 2038437-012; 6) 2038437-013; 7) 2038437-014; 8) 2038437-0XX
Open, Classified
LLZK042525
K063628
Mar 28, 2025GE Healthcare
GE Healthcare Centricity PACS-IW (PACS-IW), Model Numbers: 1) 2042988-001; 2) 2049587-009; 3) 2049587-011; 4) 2049587-012; 5) 2049587-015; 6) 2049588-012 ; 7) 2052829-001.
Open, Classified
LLZK123174
Mar 28, 2025GE Healthcare
GE Healthcare Centricity Universal Viewer (UV), Model Numbers: 1) 2066908-077; 2) 2066908-136; 3) 2066908-150; 4) 2088026-003; 5) 2088026-026; 6) 2088026-032; 7) 2088026-043; 8) 2088026-110; 9
Open, Classified
LLZK150420
K182419
Mar 20, 2025FUJIFILM Healthcare Americas Corporation
Synapse PACS Software Version 7.4.x; Software Versions: 7.4.000, 7.4.001, 7.4.010, 7.4.100, 7.4.110, 7.4.200.
Open, Classified
LLZK160108
K190232
Mar 20, 2025Merge Healthcare, Inc.
Merge Cardio, Model/Catalog Number: Version 12.X, Software Version: 12.1, 12.1.1, 12.2, 12.3, 12.3.1, 12.3.2, 12.3.3, 12.4, 12.4.1, 12.4.2; Merge Cardio is a software medical device that is an integra
Open, Classified
LLZK192206
Mar 20, 2025Merge Healthcare, Inc.
VERICIS, Merge Cardio, Model/Catalog Number: Version 12.X, Software Version: 12.0.1, 12.0.2; The VERICIS is an integrated cardiovascular information system classified as a picture archiving and commun
Open, Classified
LLZK051649
Mar 20, 2025Merge Healthcare, Inc.
VERICIS, Merge Cardio, Model/Catalog Number: Version 11.x, Software Version: 11.0.2, 11.0.3, 11.0.4, 11.1, 11.1.1; The VERICIS is an integrated cardiovascular information system classified as a pictur
Open, Classified
LLZK051649
Mar 20, 2025Merge Healthcare, Inc.
VERICIS, Merge Cardio, Model/Catalog Number: Version 10.x, Software Version: 10.0, 10.1.1.1, 10.1.2, 10.2.0, 10.2 P2 , 10.3; The VERICIS is an integrated cardiovascular information system classified a
Open, Classified
LLZK051649
Mar 20, 2025Merge Healthcare, Inc.
VERICIS, Merge Cardio, Model/Catalog Number: Version 9.x, Software Version: 9.0.6 and 9.0.8; VERICIS is an integrated cardiovascular information system classified as a picture archiving and communicat
Open, Classified
LLZK051649
Mar 18, 2025Brainlab AG
Origin Data Management software versions 3.1.0, 3.1.1, 3.1.2, 3.2.0, 3.2.1
Open, Classified
LLZK232759
Mar 4, 2025MIM Software Inc
MIM software; System, Image Processing, Radiological
Open, Classified
LLZK071964

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