OTC12D AUTO RADIOGRAPHIC SYSTEM— 510(k) K152767

Name: FDA 510(k) clearance K152767
Creator: U.S. Food and Drug Administration
Published: 2015-12-14

Substantially Equivalent

Del Medical, Inc.

FDA 510(k) clearance K152767 for OTC12D AUTO RADIOGRAPHIC SYSTEM, Substantially Equivalent on 2015-12-14. Applicant: Del Medical, Inc.. Device class: 2.

Clearance details

Applicant: Del Medical, Inc.
Product code: Code KPR
Device class: Class 2
Regulation: 21 CFR 892.1680
Advisory panel: Radiology
Date received: 2015-09-24
Decision date: 2015-12-14
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Bloomingdale, 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.