FDA product code SFH: Pathology Software Algorithm Device Analyzing Digital Images For Prostate Cancer Prognosis

SFH is the FDA product code for pathology software algorithm device analyzing digital images for prostate cancer prognosis. It is a Class II device, regulated under 21 CFR 864.3755 and reviewed by the Pathology panel. Devices under SFH reach the market by 510(k); FDA lists no cleared 510(k)s for it. 1 De Novo request was granted under it.

Definition

A pathology software algorithm device analyzing digital images for prostate cancer prognosis is a software intended to analyze digital images of acquired from medical imaging devices (for example but not limited to - whole slide imaging scanners). The device provides prognostic risk estimates which are intended to assist physicians with prognostic risk-based decisions along with other clinicopathological factors. The device is not intended to determine a clinical diagnosis.

Classification

Recalls for SFH devices

openFDA lists no recalls for product code SFH.

Frequently asked questions

What is FDA product code SFH?

SFH is the FDA product code for pathology software algorithm device analyzing digital images for prostate cancer prognosis. It is a Class II device, regulated under 21 CFR 864.3755 and reviewed by the Pathology panel.

What device class is SFH?

Class II, regulation 21 CFR 864.3755. Typical premarket route: 510(k).

Next steps

• Run an FDA pathway report with predicate devices for product code SFH
• Run a recall and safety report across every SFH manufacturer
• Watch product code SFH for new clearances and recalls

Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.

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