FDA product code SHY: Software-Aided Adjunctive Diagnostic Device For Use By Healthcare Providers In Skin Wound Assessment.

SHY is the FDA product code for software-aided adjunctive diagnostic device for use by healthcare providers in skin wound assessment.. It is a Class II device, regulated under 21 CFR 878.1840 and reviewed by the General and Plastic Surgery panel. Devices under SHY reach the market by 510(k); FDA lists no cleared 510(k)s for it.

Definition

A software-aided adjunctive diagnostic device for use by healthcare providers in skin wound assessment uses a software algorithm to analyze optical or other physical properties of a skin wound without direct wound contact and returns characterizing information that may include classification, severity, or healing potential of the skin wound. The device is intended for prescription use by healthcare providers to provide adjunctive information to be used in conjunction with clinical assessment. It is not for use as a standalone diagnostic device.

Classification

Recalls for SHY devices

openFDA lists no recalls for product code SHY.

Frequently asked questions

What is FDA product code SHY?

SHY is the FDA product code for software-aided adjunctive diagnostic device for use by healthcare providers in skin wound assessment.. It is a Class II device, regulated under 21 CFR 878.1840 and reviewed by the General and Plastic Surgery panel.

What device class is SHY?

Class II, regulation 21 CFR 878.1840. Typical premarket route: 510(k).

Next steps

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