FDA-cleared K213307

Eclipse II with Smart Noise Cancellation

Carestream Health, Inc.

The software performs digital enhancement of a radiographic image generated by an x-ray device. The software can be used to process adult and pediatric x-ray images. This excludes...

Modality
Mammography/DBT
Anatomy
Breast
Decision
2022-01-14
FDA-cleared K202441

Eclipse II with Smart Noise Cancellation

Carestream Health, Inc.

Eclipse II with Smart Noise Cancellation digitally enhances radiographic images generated by supported X-ray devices for adult and pediatric use; the cleared function is for...

Modality
X-ray/Radiography
Anatomy
Adult and pediatric radiographic anatomy excluding mammography
Decision
2021-04-02