Devices · Carestream Health, Inc.

Eclipse II with Smart Noise Cancellation

Carestream Health, Inc. is listed for Eclipse II with Smart Noise Cancellation (K202441). The FDA list gives April 2, 2021 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 MQB. 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=K202441

Official FDA database record

Date of final decision

April 2, 2021

Company on the FDA list

Carestream Health, Inc.

Lead panel

Radiology

Primary product code

MQB

openFDA device name for the code

Solid State X-Ray Imager (Flat Panel/Digital Imager)

Device class

2

Regulation number

892.1680

openFDA decision description

Substantially Equivalent

openFDA decision code

SESE

Statement or summary label

Summary