DeviceClearance

CENTRION 500 C-ARM SYSTEM— 510(k) K050866

Substantially Equivalent

Osteosys Co.,Ltd

FDA 510(k) clearance K050866 for CENTRION 500 C-ARM SYSTEM, Substantially Equivalent on 2005-04-27. Applicant: Osteosys Co.,Ltd. Device class: 2.

Clearance details

Applicant
Osteosys Co.,Ltd
Product code
Code JAA
Device class
Class 2
Regulation
21 CFR 892.1650
Advisory panel
Radiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Brookeville, MD, US
Download summary PDFView on FDA.gov ↗

Recent devices under product code JAA

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Adverse events under product code JAA

product code JAA
Other
1
Total
1

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.