Amrad Medical OTS Digital Radiography System, Amrad Medical DFMTS Digital Radiography SystemAmrad Medical FRS Digital Radiography System,— 510(k) K153119

Name: FDA 510(k) clearance K153119
Creator: U.S. Food and Drug Administration
Published: 2016-03-14

Substantially Equivalent

Summit Industries, LLC

FDA 510(k) clearance K153119 for Amrad Medical OTS Digital Radiography System, Amrad Medical DFMTS Digital Radiography SystemAmrad Medical FRS Digital Radiography System,, Substantially Equivalent on 2016-03-14. Applicant: Summit Industries, LLC. Device class: 2.

Clearance details

Applicant: Summit Industries, LLC
Product code: Code KPR
Device class: Class 2
Regulation: 21 CFR 892.1680
Advisory panel: Radiology
Date received: 2015-10-29
Decision date: 2016-03-14
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.