Devices · GE Medical Systems SCS

PROView

GE Medical Systems SCS is listed for PROView (K193306). The FDA list gives November 17, 2020 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=K193306

Official FDA database record

Date of final decision

November 17, 2020

Company on the FDA list

GE Medical Systems SCS

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