SHYClass II

Software-Aided Adjunctive Diagnostic Device For Use By Healthcare Providers In Skin Wound Assessment.

21 CFR 878.1840 / General, Plastic Surgery

SHY is the FDA product code for Software-Aided Adjunctive Diagnostic Device For Use By Healthcare Providers In Skin Wound Assessment., a class II device type, regulated under 21 CFR 878.1840. FDA's definition for this code reads: "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...". As of 2026-09-10, FDA records hold one 510(k) clearance under this code, the most recent dated 2026-05-21, and no recalls.

Classification record

Product code: SHY
Device name: Software-Aided Adjunctive Diagnostic Device For Use By Healthcare Providers In Skin Wound Assessment.
FDA 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.
Regulation: 21 CFR 878.1840
Device class: Class II
Review panel: General, Plastic Surgery
Submission type: 510(k)
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 1
Ingested recalls: 0

Clearances, product code SHY

By decision year

1 clearance under product code SHY with a decision year between 2026 and 2026, 2026 the highest year at 1.

Show the numbers

510(k) clearances under FDA product code SHY by decision year
Year	Clearances
2026	1

Applicants with the most clearances

Product code SHY

Applicants holding the most 510(k) clearances under product code SHY
Applicant	Clearances
Spectralmd, Inc.	1

Companies listing this code with FDA

Companies whose registered establishments list this code

Recent clearances

Product code SHY

DEN250028Class IIDeepView AI® SystemSpectralmd, Inc. / cleared 2026-05-21

Recent recalls

Product code SHY

FDA records show no recalls under product code SHY.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device classification database, ingested from openFDA. The definition, regulation number, device class and review panel are FDA’s own fields, reproduced without editing.

MDM adds the counts: clearances by decision year, the applicants holding the most clearances under this code, recalls that name it, and the registered establishments that list it. Every count is computed from ingested records only.

Data as of 2026-10-05, the FDA export date for this dataset. Page last changed 2026-09-05. View this product code on fda.gov (opens on fda.gov)