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FDA-cleared K213307

Eclipse II with Smart Noise Cancellation

Carestream Health, Inc.

Digitally enhances adult and pediatric radiographic x-ray images; mammography is excluded.

Modality
X-ray/Radiography
Anatomy
Exact anatomy wording was withdrawn pending re-verification.
Decision
2022-01-14
FDA-cleared K202441

Eclipse II with Smart Noise Cancellation

Carestream Health, Inc.

Authorized purpose: 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 projection radiography and excludes mammography.

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