Home › Device types › LLZ
System, Image Processing, Radiological
FDA product code LLZ · Class 2 · Radiology
5,190
Registered devices
19,647
Adverse events
554
Recalls
2,285
510(k) clearances
Devices with this code
Equinoxe — Exactech, Inc.StealthViz — MEDTRONIC NAVIGATION, INC.N/A — BIOMET MICROFIXATION, INCBed Adaptors Kit — MAZOR ROBOTICS LTDCHILI PACS — CHILI GmbHChange Healthcare Stratus Imaging PACS — Change Healthcare Canada CompanyNovaMG — Novarad Corporationsyngo Dynamics — Siemens Healthcare GmbHEPIQ 7 Diamond Select Ultrasound System — Philips Ultrasound LLCSynopsys Simpleware ScanIP — SYNOPSYS, INC.ClearRead CT Platform Docker — Riverain Technologies, Inc.K-wires 2.0X120 w/stop, 5 pack — MAZOR ROBOTICS LTDsyngo.via WebViewer — Siemens Healthcare GmbHTIMS System — FORESIGHT IMAGING, LLCIPS — KLS-Martin L.P.N/A — BIOMET MICROFIXATION, INCN/A — BIOMET MICROFIXATION, INCsyngo Dynamics — Siemens Healthcare GmbHCHILI PACS — CHILI GmbHNio Color 3MP LED — Barco NVPowerLook AMP with Density Assessment GE US — Icad, Inc.UltraSPECT — Ultraspect Usa, LLCAshvins variant Ashvins Diagnostic Workstation — MedicalCommunications GmbHVitrea Advanced Visualization — Canon Medical Informatics, Inc.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-07-22 | FUJIFILM Healthcare Americas Corporation | Software issue may cause the ruler measurement to be inaccurate. |
| 2026-07-22 | Merge Healthcare, Inc. | Software issue may cause measurements to be displayed inaccurately. |
| 2026-06-30 | Merge Healthcare, Inc. | Merge Healthcare has identified a potential issue that may cause thumbnails from a previously opened patient study to be displayed in the Thumbnail Bar while a |
| 2026-06-30 | Merge Healthcare, Inc. | Merge Healthcare has identified a potential issue that may cause thumbnails from a previously opened patient study to be displayed in the Thumbnail Bar while a |
| 2026-06-19 | Boston Scientific Corporation | Software anomaly occurs when a user adds one or more vials to the cart and subsequently returns to the Activity Calculator to modify one or more input. When a u |
| 2026-05-08 | GE Medical Systems SCS | GE HealthCare has become aware of a context synchronization issue in AW Server 3.2 ext. 6.5. When a user selects a patient or exam in the AW Server Web Client w |
| 2026-03-19 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | Potential safety issue involving the Mean Aneurysm Flow Amplitude (MAFA) ratio of AneurysmFlow (Interventional Tool). Philips has determined that the MAFA ratio |
| 2026-03-05 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | Potential that mis-ordered frames in Vue Motion during dynamic cine runs may cause images frames to display out of sequence. |
| 2026-01-30 | GE Medical Systems, LLC | There is a potential cybersecurity vulnerability affecting certain versions of Centricity Universal Viewer. User login credentials may be exposed on the local c |
| 2026-01-30 | GE Medical Systems, LLC | There is a potential cybersecurity vulnerability affecting certain versions of Centricity Universal Viewer. User login credentials may be exposed on the local c |
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