System, Image Processing, Radiological
Regulation 892.2050
48510(k)s in 12 months (2,295 all time)
25recalls in 12 months (562 all time)
544recalls 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) |
|---|---|---|---|
| Mar 4, 2025 | MIM Software Inc MIM software; System, Image Processing, Radiological Open, Classified |
LLZ | K071964 |
| Feb 28, 2025 | Philips Medical Systems Nederland B.V. Philips IntelliSpace Cardiovascular software, Model 830089. Open, Classified |
LLZ | K153022 |
| Feb 21, 2025 | INTELERAD MEDICAL SYSTEMS INCORPORATED IntelePACS (Image Fusion Module) - InteleViewer Open, Classified |
LLZ | K192176 |
| Feb 7, 2025 | Medicrea International UNiD" Adaptive Spine Intelligence
UNiD Spine Analyzer Product Number SW3002 UDI-DI code 03613720286929
Two cloud-based software applications within UNiD Adaptive Spine Intelligence (ASI): the UNiD H Open, Classified |
LLZ | K212005 |
| Dec 20, 2024 | Mint Medical GmbH mint Lesion, Software Versions: 3.10.0 and 3.10.1. Open, Classified |
LLZ | K142647 |
| Dec 20, 2024 | Mint Medical GmbH mint Lesion, Software Versions: 3.9.0 through 3.9.5. Open, Classified |
LLZ | K142647 |
| Nov 20, 2024 | Philips Medical Systems Technologies Ltd. Vue PACS Diagnostic Viewer with Vue PACS client 12.1.5 to 12.2.8.454 software
Model Number: 1149418
Intended use is to provide completely scalable local and wide area PACS (Picture Archiving and Com Open, Classified |
LLZ | K110919 K153103 |
| Nov 7, 2024 | GE Healthcare GE Healthcare Centricity Universal Viewer Zero Footprint, Model Numbers:
1) 2089507-083, GDZH-JINWAN-Centricity
2) 2089507-093, 10510-3-Centricity Universal Viewer Zero Footprint / ZFP-02268286, 105 Open, Classified |
LLZ | K131977 |
| Oct 10, 2024 | Agfa Healthcare NV Enterprise Imaging XERO Viewer- software application used for reference and diagnostic viewing of multispecialty medical imaging and non-imaging data .
Enterprise Imaging XERO Viewer 8.0.0, 8.0.1, 8. Open, Classified |
LLZ | K170434 |
| Oct 9, 2024 | GE Healthcare GE Healthcare Centricity Universal Viewer Zero Footprint Client, Model/Catalog/Code Numbers:
a) 2089507-120;
b) 2089507-129;
c) 2089507-131;
d) 2089507-135;
e) 2089507-136;
f) 2089507-140;
g) Open, Classified |
LLZ | K131977 |
| Sep 24, 2024 | GE Healthcare GE Healthcare Centricty PACS, V2, V3, V4, V6, V7; Radiological imaging processing system. Open, Classified |
LLZ | K043415 K110875 |
| Sep 17, 2024 | GE Healthcare GE Healthcare Centricity Universal Viewer Zero Footprint Client, Model Numbers:
a) 2110344-008;
b) 2110344-009;
c) 2110344-010;
d) 2110344-011;
e) 2110344-013;
f) 2110344-019;
g) 2110344-025; Open, Classified |
LLZ | K131977 |
| Sep 13, 2024 | GE Healthcare GmbH ViewPoint 6, Model Numbers: a) H47581RJ, b) H47591MA, c) H47591MT, d) H47591PE, e) H47591PR, f) H47591RA, g) H47591SD, h) H47591YA; system, imaging processing, radiological Open, Classified |
LLZ | K103458 K162743 +4 |
| Sep 13, 2024 | GE Healthcare GmbH ViewPoint; system, imaging processing, radiological Open, Classified |
LLZ | K050943 |
| Mar 7, 2024 | FUJIFILM Healthcare Americas Corporation Synapse PACS - Version 7.3.000 Open, Classified |
LLZ | K190232 |
| Mar 7, 2024 | FUJIFILM Healthcare Americas Corporation Synapse PACS - Version 7.2.200 Open, Classified |
LLZ | K190232 |
| Mar 7, 2024 | FUJIFILM Healthcare Americas Corporation Synapse PACS - Version 7.2.100 Open, Classified |
LLZ | K190232 |
| Mar 7, 2024 | FUJIFILM Healthcare Americas Corporation Synapse PACS - Version 7.2.000 Open, Classified |
LLZ | K190232 |
| Mar 7, 2024 | FUJIFILM Healthcare Americas Corporation Synapse PACS - Version 7.1.000US Open, Classified |
LLZ | K190232 |
| Mar 7, 2024 | FUJIFILM Healthcare Americas Corporation Synapse PACS - Version 7.1.000 Open, Classified |
LLZ | K190232 |
| Feb 21, 2024 | FUJIFILM Healthcare Americas Corporation Synapse CV 6. with AR.
A web-based application as the primary user interface for the processing of medical images. Open, Classified |
LLZ | K151859 |
| Feb 21, 2024 | FUJIFILM Healthcare Americas Corporation Synapse Cardiology PACS V7.3.0, V7.2, V7.1, V7.0.
A web-based application as the primary user interface for the processing of medical images. Open, Classified |
LLZ | K190232 |
| Dec 14, 2023 | CHANGE HEALTHCARE CANADA COMPANY Change Healthcare Stratus Imaging PACS 1.4 and Stratus Imaging Share 1.4, a component of Stratus Imaging PACS. Open, Classified |
LLZ | K203249 |
| Nov 6, 2023 | CHANGE HEALTHCARE CANADA COMPANY Change Healthcare Radiology Solutions, software versions 14.0, 14.1, and 14.2
Medical image and information management software. Open, Classified |
LLZ | K140909 |
| Oct 23, 2023 | GE Healthcare Universal Viewer Workflow Manager, Image processing radiological system Open, Classified |
LLZ | K211312 |
| Oct 23, 2023 | GE Healthcare Centricity Universal Viewer Workflow Manager, Image processing radiological system Open, Classified |
LLZ | K182419 |
| Oct 20, 2023 | GE Healthcare Centricity Universal Viewer, software versions 6.0 SP0 through 6.0 SP7.1; Radiological Image Processing System Open, Classified |
LLZ | K150420 |
| Oct 20, 2023 | GE Healthcare Centricity PACS-IW with Universal Viewer, versions 5.0 SPx with PACS-IW foundation; Radiological Image Processing System Open, Classified |
LLZ | K123174 |
| Oct 20, 2023 | GE Healthcare Centricity PACS-IW, software versions V3.7.x through 3.7.3.9 SP3; Radiological Image Processing System Open, Classified |
LLZ | K082318 |
| Oct 18, 2023 | OLEA MEDICAL Functional MR V1.0 Open, Classified |
LLZ | K221426 |
| Sep 25, 2023 | Exocad GmbH exoplan version 3.1 Rijeka Software -A medical software, intended to support the pre-operative planning of dental implants using the visualization of the implant placement within images of the patents Open, Classified |
LLZ | K213302 |
| Jul 21, 2023 | Virtual Radiologic Corp. vRad PACS with Mammography Open, Classified |
LLZ | K162145 |
| Jul 20, 2023 | Digisonics, Inc Digisonics OBView Versions 4.8.2 SP6 - 4.8.3, Ultrasound reporting software Open, Classified |
LLZ | K970402 |
| May 2, 2023 | GE Healthcare Centricity PACS-IW, Product ID Numbers: a) 2041037-001, b) 2042988-001, c) 2049587-009, d) 2049587-011, e) 2049587-012, f) 2049587-015, g) 2052829-001, h) Not applicable;
Radiological Image Processi Open, Classified |
LLZ | K082318 |
| May 2, 2023 | GE Healthcare Centricity Universal Viewer, Centricity Universal Viewer 6.0, Model/Catalog Numbers:
a) 2088026-003,
b) 2088026-026,
c) 2088026-032,
d) 2088026-043,
e) 2088026-044,
f) 2088026-115,
g) 2088026 Open, Classified |
LLZ | K150420 |
| May 2, 2023 | GE Healthcare Centricity PACS-IW with Universal Viewer, Model/Catalog Numbers: a) 2066908-061, b) 2066908-077, c) 2066908-086, d) 2066908-111, e) 2066908-123, f) 2066908-136, g) 2066908-150; Radiological Image Pro Open, Classified |
LLZ | K123174 |
| Jan 20, 2023 | Agfa Healthcare NV Agfa HealthCare Enterprise Imaging XERO Viewer Open, Classified |
LLZ | K170434 |
| Dec 16, 2022 | GE Medical Systems, LLC Centricity Universal Viewer 6.0.
Used to display medical images (Including mammograms) and data from various imaging sources. Open, Classified |
LLZ | K150420 |
| Dec 16, 2022 | GE Medical Systems, LLC Centricity PACS-IW with Universal Viewer version 5.0.
Used to display medical images (Including mammograms) and data from various imaging sources. Open, Classified |
LLZ | K123174 |
| Sep 27, 2022 | DICOM Grid, Inc. d/b/a Ambra Health Ambra PACS, Ambra ProViewer. Software for use as a primary diagnostic and analysis tool for diagnostic images. Open, Classified |
LLZ | K202335 |
| Aug 24, 2022 | GE Healthcare, LLC (1) GE Centricity Universal Viewer 6.0, Model 2088026-9XX; (2) GE Centricity Universal Viewer 7.0, Model 5826659-0XX; (3) GE Universal Viewer 8.0, Model 5865740-00x. Open, Classified |
LLZ | K150420 K182419 +1 |
| Jul 5, 2022 | GE Healthcare, LLC GE Centricity Universal Viewer Zero Footprint. To view, communicate, process, and display Medical images and data within a computer network or on a workstation. Open, Classified |
LLZ | K131977 |
| Jun 16, 2022 | NordicNeuroLab AS nordicBrainEX, software versions 2.21 through 2.3.10 Terminated |
LLZ | K133910 |
| Jun 14, 2022 | GE Healthcare, LLC Centricity PACS Software Version 7.0 SP0.0.4.7 Terminated |
LLZ | K110875 |
| Jun 3, 2022 | GE Healthcare, LLC Centricity PACS RA1000 Open, Classified |
LLZ | K110875 |
| Jun 3, 2022 | GE Healthcare, LLC Centricity Cardiology CA1000 Open, Classified |
LLZ | None listed |
| Jun 3, 2022 | GE Healthcare, LLC Centricity Radiology RA600 Open, Classified |
LLZ | K042525 K063628 |
| Jun 3, 2022 | GE Healthcare, LLC Centricity Enterprise Web Open, Classified |
LLZ | None listed |
| Jun 3, 2022 | GE Healthcare, LLC Centricity Universal Viewer Zero Footprint Client Open, Classified |
LLZ | K131977 |
| Feb 2, 2022 | Philips North America Llc Philips Allura (Model Numbers 722010, 722012, 722026, 722027, 722028, 722029, 722035) and Philips Azurion (Model Numbers 722063, 722064, 722067, 722068, 722078, 722079, 722221, 722222, 722223, 722224, Open, Classified |
LLZ | K141979 K170144 +2 |
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