OTC12D AUTO RADIOGRAPHIC SYSTEM— 510(k) K152767

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..

Clearance details

Applicant: Del Medical, Inc.
Product code: Code KPR
Advisory panel: Radiology
Date received: 2015-09-24
Decision date: 2015-12-14
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Bloomingdale, IL, US

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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.