LLZ · System, Image Processing, Radiological
Radiology · 21 CFR 892.2050 · Class 2
Overview
| Product Code | LLZ |
|---|---|
| Device Name | System, Image Processing, Radiological |
| Regulation | 21 CFR 892.2050 |
| Device Class | Class 2 |
| Review Panel | Radiology |
| 3rd-Party Reviewable | Yes |
Identification
A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.
Classification Rationale
Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).
Special Controls
*Classification.* Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).
Recent Cleared Devices (20 of 2270)
Showing 20 most recent of 2270 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K254265 | Helion Viewer Suite | Videomed Srl ( a Baxter Healthcare Corp company) | May 27, 2026 | SESE |
| K253831 | CMN Capillary Function with Virtual Expert for MRI, CT and CBCT | Cercare Medical A/S | May 18, 2026 | SESE |
| K254013 | SubtleHD-PET (1.x) | Subtle Medical, Inc. | May 14, 2026 | SESE |
| K260321 | HipGuide (V 1.0.0.0) | Orthopedic Driven Imaging, LLC | May 8, 2026 | SESE |
| K260716 | Neowise | Cefla S.C. | May 4, 2026 | SESE |
| K260009 | LungPoint Virtual Bronchoscopic Navigation (VBN) Software | Broncus Medical, Inc. | Apr 24, 2026 | SESE |
| K254237 | CCI PACS VIEWER (PACS-US-001) | CliniComp, Intl. | Apr 23, 2026 | SESE |
| K253029 | RW-1 | Mediott, Inc. | Mar 31, 2026 | SESE |
| K253950 | Avatar Medical Vision | Avatar Medical | Mar 30, 2026 | SESE |
| K252195 | ARTICOR planner | Artiness S.R.L | Mar 27, 2026 | SESE |
| K260479 | TheraSphere 360™ Y-90 Management Platform | Boston Scientific Corporation | Mar 13, 2026 | SESE |
| K253111 | Aeka Imaging | Good Methods Global, Inc. | Mar 13, 2026 | SESE |
| K251964 | Mimics Thoracic Planner | Materialise NV | Mar 12, 2026 | SESE |
| K253486 | SKIA-Head (Model: SKIA-ST00) | Skia, Inc. | Feb 23, 2026 | SESE |
| K260205 | AS Software Version Asera | AS Software, LLC | Feb 19, 2026 | SESE |
| K253927 | LiveMedica Enterprise PACS | Live Medica, LLC | Feb 6, 2026 | SESE |
| K251577 | LAIA XR | Augmented Reality Software S.L. | Feb 6, 2026 | SESE |
| K253784 | 3DICOM MD Cloud | Singular Health Pty, Ltd. | Jan 8, 2026 | SESE |
| K253639 | View | GE Healthcare | Jan 8, 2026 | SESE |
| K253008 | maiLink | Maihub Corp. | Jan 5, 2026 | SESE |
Top Applicants
- Siemens Medical Solutions USA, Inc. — 74 clearances
- Totoku Electric Co., Ltd. — 40 clearances
- Barco N.V. — 37 clearances
- Eizo Nanao Corporation — 34 clearances
- Vital Images, Inc. — 34 clearances
