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)
Top companies in LLZ
| Company | 510(k)s | Recalls |
|---|---|---|
| Siemens AG Medical Solutions | 95 | 89 |
| GE Healthcare | 23 | 84 |
| Merge Healthcare Incorporated | 6 | 61 |
| Carestream Health, Inc. | 9 | 53 |
| Vital Images, Inc. | 34 | 10 |
| Agfa Corp. | 6 | 34 |
| Totoku Electric Co., Ltd. | 40 | 0 |
| Barco N.V. | 37 | 0 |
| Eizo Nanao Corporation | 34 | 0 |
| Ewoosoft Co., Ltd. | 29 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 15, 2026 | INTELERAD 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 |
LLZ | K192176 |
| Sep 15, 2026 | GE 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 |
LLZ | K043415 K110875 |
| Sep 15, 2026 | GE 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 |
LLZ | K043415 K110875 |
| Sep 15, 2026 | GE Healthcare Centricity PACS Server V7, intended for managing digital medical images and associated data, All versions Open, Classified |
LLZ | K043415 K110875 |
| Sep 15, 2026 | GE 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 |
LLZ | K043415 K110875 |
| Sep 15, 2026 | GE Healthcare Enterprise Archive V8, software product for receiving, archiving, and sending electronic medical data, All versions Open, Classified |
LLZ | K043415 K110875 |
| Sep 15, 2026 | GE Healthcare Centricity Enterprise Archive V2, V3, and V4, software product for receiving, archiving, and sending electronic medical data, All Versions Open, Classified |
LLZ | K043415 K110875 |
| Aug 26, 2026 | FUJIFILM Healthcare Americas Corporation FUJIFILM Synapse PACS software v7.4.310; radiological image processing system Open, Classified |
LLZ | K190232 |
| Aug 21, 2026 | Merge Healthcare, Inc. Merge PACS and Merge OrthoPACS, medical imaging diagnostic workstation Open, Classified |
LLZ | K192455 |
| Aug 4, 2026 | Merge Healthcare, Inc. Merge OrthoPACS, medical imaging diagnostic workstation Open, Classified |
LLZ | K192455 |
| Aug 4, 2026 | Merge Healthcare, Inc. Merge PACS, medical imaging diagnostic workstation Open, Classified |
LLZ | K192455 |
| Jul 22, 2026 | Boston Scientific Corporation Boston Scientific TheraSphere 360 Y-90 Management Platform, Model Number M00139509001; Radiological Image Processing System. Open, Classified |
LLZ | K252547 K260479 |
| Jun 24, 2026 | GE Medical Systems SCS GE Healthcare AW Server 3.2 ext.6.5; Radiological Image Processing System Open, Classified |
LLZ | K081985 |
| May 6, 2026 | Mint Medical GmbH Mint Lesion;
Software Versions: 3.4.0 up to 3.9.5.; Open, Classified |
LLZ | K142647 |
| Apr 10, 2026 | PHILIPS 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 |
LLZ | K160455 |
| Mar 27, 2026 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Vue Motion V12. Product Number: 1017979. Open, Classified |
LLZ | K151774 |
| Mar 16, 2026 | GE 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 |
LLZ | K123174 |
| Mar 16, 2026 | GE 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 |
LLZ | K150420 |
| Mar 16, 2026 | GE 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 |
LLZ | K182419 |
| Feb 27, 2026 | GE Healthcare GE Healthcare Centricity Universal Viewer Zero Footprint Client, Model Numbers: 2110344-039, 2110344-046, 2110344-047; System, Image Processing, Radiological Open, Classified |
LLZ | K131977 |
| Feb 3, 2026 | Focalyx Technologies, LLC. Focalyx Fusion Open, Classified |
LLZ | K170250 |
| Dec 18, 2025 | DICOM Grid, Inc. Intelerad InteleShare software, with ProViewer component Open, Classified |
LLZ | K231360 |
| Dec 16, 2025 | GE Healthcare GmbH GE HealthCare ViewPoint 6, Catalog Number H47601AA; Radiological image processing system Open, Classified |
LLZ | K241300 |
| Nov 26, 2025 | INTELERAD MEDICAL SYSTEMS INCORPORATED IntelePACS - InteleConnect / TechPortal Open, Classified |
LLZ | K192176 |
| Oct 24, 2025 | Surgical Theater Inc Surgical Planner, BrainSTORM, software version BST.9.3.0, orthopedic augmented reality Terminated |
LLZ | K201465 |
| Oct 24, 2025 | Surgical Theater Inc Endo Surgical Navigation Advanced Platform Patient Engagement (EndoSNAP), software version SNP.1.12.0, imaging processing radiological system Terminated |
LLZ | K160584 |
| Oct 24, 2025 | Surgical Theater Inc SyncAR Surgical Navigation Advanced Platform Patient Engagement (SyncAR SNAP), software version SNP.1.12.0, imaging processing radiological system Terminated |
LLZ | K160584 |
| Oct 24, 2025 | Surgical Theater Inc Surgical Navigation Advanced Platform Patient Engagement (PE SNAP), software version SNP.3.12.0, imaging processing radiological system Terminated |
LLZ | K160584 |
| Oct 24, 2025 | Surgical Theater Inc Surgical Navigation Advanced Platform (SNAP), software version SNP.3.12.0, imaging processing radiological system Terminated |
LLZ | K160584 |
| Oct 24, 2025 | Surgical Theater Inc SuRgical Planner (SRP), software version SRP.7.12.0, imaging processing radiological system Terminated |
LLZ | K170793 |
| Oct 8, 2025 | GE Medical Systems, SCS AW Server 2.0, AW Server 3.0, AW Server 3.1, AW Server 3.2 Open, Classified |
LLZ | K081985 |
| Oct 2, 2025 | CHANGE HEALTHCARE CANADA COMPANY Change Healthcare Radiology Solutions software version 14.2.2 Open, Classified |
LLZ | K140909 |
| Sep 9, 2025 | Philips Medical Systems Nederland B.V. IntelliSpace Cardiovascular, Software 8.0.0.4. Open, Classified |
LLZ | K153022 |
| Aug 12, 2025 | PIE Medical Imaging B.V. 3mensio Workstation (Vascular Fenestrated) software Open, Classified |
LLZ | K153736 |
| May 21, 2025 | Echopixel, 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 |
LLZ | K142107 |
| May 16, 2025 | Echopixel, Inc. True 3D Viewer, Model: EP-00003 Open, Classified |
LLZ | K170167 |
| May 8, 2025 | Philips Medical Systems Nederland B.V. IntelliSpace Cardiovascular software versions 6.x, 7.x, and 8.x; Model Number: 830089. Open, Classified |
LLZ | K153022 |
| Mar 28, 2025 | GE 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 |
LLZ | None listed |
| Mar 28, 2025 | GE 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 |
LLZ | K042525 K063628 |
| Mar 28, 2025 | GE 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 |
LLZ | K042525 K063628 |
| Mar 28, 2025 | GE 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 |
LLZ | K123174 |
| Mar 28, 2025 | GE 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 |
LLZ | K150420 K182419 |
| Mar 20, 2025 | FUJIFILM 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 |
LLZ | K160108 K190232 |
| Mar 20, 2025 | Merge 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 |
LLZ | K192206 |
| Mar 20, 2025 | Merge 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 |
LLZ | K051649 |
| Mar 20, 2025 | Merge 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 |
LLZ | K051649 |
| Mar 20, 2025 | Merge 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 |
LLZ | K051649 |
| Mar 20, 2025 | Merge 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 |
LLZ | K051649 |
| Mar 18, 2025 | Brainlab AG Origin Data Management software versions 3.1.0, 3.1.1, 3.1.2, 3.2.0, 3.2.1 Open, Classified |
LLZ | K232759 |
| Mar 4, 2025 | MIM Software Inc MIM software; System, Image Processing, Radiological Open, Classified |
LLZ | K071964 |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.