Smart-C— 510(k) K190024

Name: FDA 510(k) clearance K190024
Creator: U.S. Food and Drug Administration
Published: 2019-09-27

Substantially Equivalent

Turner Imaging Systems, Inc.

FDA 510(k) clearance K190024 for Smart-C, Substantially Equivalent on 2019-09-27. Applicant: Turner Imaging Systems, Inc.. Device class: 2.

Clearance details

Applicant: Turner Imaging Systems, Inc.
Product code: Code OXO
Device class: Class 2
Regulation: 21 CFR 892.1650
Advisory panel: Radiology
Date received: 2019-01-07
Decision date: 2019-09-27
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Orem, UT, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code OXO

product code OXO

Death: 6
Injury: 163
Malfunction: 2,099
Other: 1
Total: 2,269

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.