PEDRA-17F Digital Flat Panel X-ray Detector— 510(k) K180989

Substantially Equivalent

Radisen, Inc.

FDA 510(k) clearance K180989 for PEDRA-17F Digital Flat Panel X-ray Detector, Substantially Equivalent on 2018-06-13. Applicant: Radisen, Inc..

Clearance details

Applicant: Radisen, Inc.
Product code: Code MQB
Advisory panel: Radiology
Date received: 2018-04-16
Decision date: 2018-06-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Seoul, KR

Download summary PDF View on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.