DR 800 with MUSICA Dynamic

510(k)K180589RadiologyJAA

Agfa HealthCare N.V. is listed for DR 800 with MUSICA Dynamic (K180589). The FDA list gives April 5, 2018 as the date of the final decision. The lead panel is Radiology, and the database link on the FDA list is the 510(k) pathway. The primary product code on the FDA list is JAA. openFDA did not return a classification record for that code in this copy of the data. openFDA records this submission’s decision description as “Substantially Equivalent.” This paragraph is assembled only from those public fields. It is not an FDA review, not a determination of safety or effectiveness, and not medical advice. Official record: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K180589

Official FDA database record

Date of final decision: April 5, 2018
Company on the FDA list: Agfa HealthCare N.V.
Lead panel: Radiology
Primary product code: JAA
openFDA device name for the code: System, X-Ray, Fluoroscopic, Image-Intensified
Device class: 2
Regulation number: 892.1650
openFDA decision description: Substantially Equivalent
openFDA decision code: SESE
Statement or summary label: Summary