Diagnostic X-ray System— 510(k) K150663

Substantially Equivalent

Osko, Inc.

FDA 510(k) clearance K150663 for Diagnostic X-ray System, Substantially Equivalent on 2015-05-07. Applicant: Osko, Inc..

Clearance details

Applicant: Osko, Inc.
Product code: Code KPR
Advisory panel: Radiology
Date received: 2015-03-16
Decision date: 2015-05-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Miami, FL, US

Download summary PDF View on FDA.gov ↗

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.