Home › Device types › LLZ
System, Image Processing, Radiological
FDA product code LLZ · Class 2 · Radiology
5,423
Registered devices
19,970
Adverse events
561
Recalls
2,293
510(k) clearances
Devices with this code
Roentgen Works — Brit Systems, LLC5.5/6.0 Arm Guide Screw Kit — MAZOR ROBOTICS LTDSubtleALIGN — Subtle Medical, Inc.TrackX — TrackX Technology, LLCAccuPlan System — MedcadPointCloud Knee Instruments — Unik Orthopedics Inc.AmCAD UT Detection — AMCAD BIOMED CORPORATIONSchanz Bond — MAZOR ROBOTICS LTDMedtronic Navigation — MEDTRONIC NAVIGATION, INC.NovaPACS — Novarad CorporationPULSE — Nuvasive, Inc.NEC — NEC DISPLAY SOLUTIONS, LTD.Viz CTP — VIZ.AI, INC.IMAGEGRID RADIOLOGY VIEWER SYSTEM — CANDELIS, INC.SA Reduction Tube, 10 pack — MAZOR ROBOTICS LTDProbe sensor assembly for Hitachi V53W — UC-CARE LTDElements Viewer — Brainlab SE3mensio Workstation — Pie Medical Imaging B.V.TIMS System — FORESIGHT IMAGING, LLCPointCloud Knee Instruments — Unik Orthopedics Inc.SA Reduction Tube — MAZOR ROBOTICS LTDSurgeon's screen Sterile Sleeve,10 pack — MAZOR ROBOTICS LTDIPS — KLS-Martin L.P.Archimedes System — BRONCUS MEDICAL INC.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-09-05 | INTELERAD MEDICAL SYSTEMS INCORPORATED | Following a Chromium-based web-browser, report and displayed images may not match. |
| 2026-07-31 | GE Healthcare | Under certain conditions historical imaging data migrated from a legacy system may become incorrectly associated with a different patient. If this occurs, studi |
| 2026-07-31 | GE Healthcare | Under certain conditions historical imaging data migrated from a legacy system may become incorrectly associated with a different patient. If this occurs, studi |
| 2026-07-31 | GE Healthcare | Under certain conditions historical imaging data migrated from a legacy system may become incorrectly associated with a different patient. If this occurs, studi |
| 2026-07-31 | GE Healthcare | Under certain conditions historical imaging data migrated from a legacy system may become incorrectly associated with a different patient. If this occurs, studi |
| 2026-07-31 | GE Healthcare | Under certain conditions historical imaging data migrated from a legacy system may become incorrectly associated with a different patient. If this occurs, studi |
| 2026-07-31 | GE Healthcare | Under certain conditions historical imaging data migrated from a legacy system may become incorrectly associated with a different patient. If this occurs, studi |
| 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 |
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