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Opulus™ Lymphoma Precision

🇺🇸Roche Molecular Systems, Inc. · MR image reconstruction/enhancement

What it does

Reconstructs mr images so scans acquired faster or at lower dose come out sharper and less noisy, without new hardware.

Who it's for

Imaging departments wanting shorter scans or higher throughput without buying new hardware.

Reported performance

No sensitivity / specificity / AUC was disclosed in the available summary. Many summaries report no standalone metrics — we note that honestly rather than imply a number.

Performance numbers are manufacturer-reported and often single-site; treat them as a starting point, not an independent benchmark.

FDA

Pathway510(k)
Submission #K243863
Product codeQIH
Decision dateMay 30, 2025
PanelRadiology
FDA recordaccessdata

EU (CE)

Statusunknown
Risk class
Notified body
EMDN code
Basic UDI-DI
AI Act class

EU coverage is filling out through 2026; absence here doesn't mean a device isn't CE-marked.

Vendor

Cite this page

RadPigeon. "Opulus™ Lymphoma Precision (Roche Molecular Systems, Inc.)." AI Devices registry. https://radpigeon.news/ai/device/opulus-lymphoma-precision

Last updated Jun 29, 2026. Information only — not clinical advice. Summaries are RadPigeon's own wording.