CLEARREAD +CONFIRM

510(k)K123526RadiologyLLZ

RIVERAIN TECHNOLOGIES is listed for CLEARREAD +CONFIRM (K123526). The FDA list gives December 27, 2012 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 LLZ. 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=K123526

Official FDA database record

Date of final decision: December 27, 2012
Company on the FDA list: RIVERAIN TECHNOLOGIES
Lead panel: Radiology
Primary product code: LLZ
openFDA device name for the code: System, Image Processing, Radiological
Device class: 2
Regulation number: 892.2050
openFDA decision description: Substantially Equivalent
openFDA decision code: SESE
Statement or summary label: Summary