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The Coronis Fusion 10MP (MDCG-10130) is intended to be used in displaying and viewing digital images, including digital mammography, for review and analysis by trained medical practitioners.

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This FDA 510(k) clearance letter dated June 23, 2010, for the Coronis Fusion 10MP (MDCG-10130) display device does not contain the detailed information needed to answer the specific questions about acceptance criteria and the study proving device performance as requested.

The letter primarily:

• Confirms review of the 510(k) premarket notification.
• States the device is substantially equivalent to legally marketed predicate devices.
• Classifies the device as Class II (Picture archiving and communications system, Product Code LLZ).
• Outlines general regulatory requirements the manufacturer must adhere to.
• Includes an "Indications For Use" statement which specifies the device "is intended to be used in displaying and viewing digital images, including digital mammography, for review and analysis by trained medical practitioners."

Crucially, this document does not elaborate on:

1. Acceptance criteria (e.g., luminance, uniformity, calibration accuracy, spatial resolution, bit depth conformance for image display) that Barco NV had to meet for their device.
2. Reported device performance against any specific criteria.
3. Details of any studies conducted (e.g., sample size, data provenance, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details) to demonstrate the device meets those criteria.

Such details would typically be found in the original 510(k) submission document itself, which is a much more extensive technical dossier provided by the manufacturer to the FDA for review, rather than in the FDA's clearance letter. The clearance letter only announces the outcome of that review.

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