Philips Medical Systems Nederland B.V. · Class II · Cleared Jul 15, 2025
| K-number | K250181 |
| Device name | AV Viewer |
| Applicant | Philips Medical Systems Nederland B.V. |
| Product code | LLZ |
| Device class | Class II |
| Decision date | Jul 15, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 892.2050 |
The AV Viewer is advanced visualization software that processes and displays medical images from multiple modalities (CT, MR, PET, SPECT, US, XA, DX, CR, RF, NM, EMR, Spectral CT, CBCT) in a clinical setting. It performs digital image processing, measurement, manipulation, quantification, and communication functions, with explicit exclusion from mammography use.
The AV Viewer supports a broader range of imaging modalities than its predicate device (Illumeo), including CBCT, Spectral CT, EMR, and NM. It offers explicit cine view capability for CT, SPECT, PET, NM, MR, and US sequences. Both devices share core features: 2D/3D viewing, 2D measurements, 3D segmentation, finding dashboard, reporting, and report/image export capabilities.
Not stated in this summary.
The AV Viewer is substantially equivalent to Illumeo because both devices fall under the same regulatory classification (Class II, 21 CFR 892.2050), product code (LLZ), and indications for use as medical image management and processing systems. The minor technological differences—expanded modality support and enhanced cine view functionality—do not introduce new safety or effectiveness concerns; these features are already present in reference devices (IntelliSpace Portal Platform and IQon Spectral CT). Verification and validation testing confirmed the device meets its intended use and user requirements with no new issues identified.
View the full FDA submission: accessdata.fda.gov