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CS-series-FP Radiographic / Fluoroscopic Systems with Optional CA-100S / FluoroShield™ (ROI Assembly)

🇺🇸Omega Medical Imaging, LLC · System, X-Ray, Fluoroscopic, Image-Intensified

What it does

Supports the imaging workflow around multi-modality studies — routing, scheduling, or image management — rather than interpreting the images.

Who it's for

Imaging departments and informatics teams managing study flow.

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 #K191713
Product codeJAA
Decision dateOct 4, 2019
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. "CS-series-FP Radiographic / Fluoroscopic Systems with Optional CA-100S / FluoroShield™ (ROI Assembly) (Omega Medical Imaging, LLC)." AI Devices registry. https://radpigeon.news/ai/device/cs-series-fp-radiographic-fluoroscopic-systems-with-optional-ca-100s-fluoroshiel

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