DeviceClearance

ELIAN Digital Diagnostic X-ray System— 510(k) K150506

Substantially Equivalent

Osko, Inc.

FDA 510(k) clearance K150506 for ELIAN Digital Diagnostic X-ray System, Substantially Equivalent on 2015-04-08. Applicant: Osko, Inc..

Clearance details

Applicant
Osko, Inc.
Product code
Code KPR
Advisory panel
Radiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Miami, FL, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code KPR

product code KPR
Other
6
Total
6

Source: openFDA MAUDE database, through . 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.