SHQ

Dental Image Analyzer, In-Office

Product code
SHQ
Device name
Dental Image Analyzer, In-Office
Device class
Class 2
21 CFR
21 CFR 872.1770
Medical specialty
Dental
Marketing pathway
510(K)
510(k) clearances (last 3 years)
1
Summaries archived here
1 (direct download)
510(k) clearances (all years, FDA)
1 (all years; only the last 3 years are listed here)

FDA classification definition

A dental image analyzer for in-office use is a prescription device that uses software intended to collect and analyze patient-specific, optical camera-based, intraoral images to be used by dental health care professionals as an aid to diagnosis of oral health conditions.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (1)

Last three years. Most recent: 2026-04-10.

NumberDecision dateApplicantDevice nameSummary
K2600822026-04-103Shape TRIOS A/STRIOS Dx (R1)PDF

1 summaries are archived here for direct download.

Official FDA classification page: SHQ
Classification and pathway per current FDA publications. Data from openFDA (CC0).