FDA-cleared K250914
MediAI-BA
Crescom Co., Ltd.
Image analysis/processing.
- Modality
- X-ray/Radiography
- Anatomy
- N/A
- Decision
- 2025-12-18
FDA-cleared profile
Eclipse II with Smart Noise Cancellation
Image analysis/processing.
Buyer-fit notes
Eclipse II with Smart Noise Cancellation is best reviewed for X-ray/Radiography teams evaluating x-ray/radiography workflow tools with FDA source traceability.
Not ideal for buyers who need public price benchmarks before vendor contact or teams requiring confirmed deployment details before shortlist review.
FDA and evidence source ledger
Clinical use
Image analysis/processing.
Alternatives
Related tools to compare
FDA-cleared K253269
OEC One CFD
Ge Hualun Medical Systems Co. , Ltd.
Image analysis/processing.
- Modality
- X-ray/Radiography
- Anatomy
- N/A
- Decision
- 2025-11-26
FDA-cleared K252086
DTX Studio Assist
Nobel Biocare C/O Medicim NV
Image analysis/processing.
- Modality
- X-ray/Radiography
- Anatomy
- N/A
- Decision
- 2025-11-17
FDA-cleared K251078
AutoDensity
Eos Imaging
Image analysis/processing.
- Modality
- X-ray/Radiography
- Anatomy
- N/A
- Decision
- 2025-11-14