Amrad Medical AAU Digital Radiography System +3 more— 510(k) K173823

Name: FDA 510(k) clearance K173823
Creator: U.S. Food and Drug Administration
Published: 2018-02-09

Substantially Equivalent

Summit Industries, LLC

FDA 510(k) clearance K173823 for Amrad Medical AAU Digital Radiography System +3 more, Substantially Equivalent on 2018-02-09. Applicant: Summit Industries, LLC. Device class: 2.

Clearance details

Device name as filed: Amrad Medical AAU Digital Radiography System; Amrad Medical AAU Plus Digital Radiography System; Amrad Medical DFMT Digital Radiography System; Amrad Medical FMT Digital Radiography System
Applicant: Summit Industries, LLC
Product code: Code KPR
Device class: Class 2
Regulation: 21 CFR 892.1680
Advisory panel: Radiology
Date received: 2017-12-18
Decision date: 2018-02-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chicago, IL, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code KPR

product code KPR

Other: 6
Total: 6

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.