FDA-cleared K250959
BioticsAI
Bioticsai, Inc.
Image analysis/processing.
- Modality
- Ultrasound
- Anatomy
- N/A
- Decision
- 2025-12-22
FDA-cleared profile
EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System
Image analysis/processing.
Buyer-fit notes
EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System is best reviewed for Ultrasound teams evaluating ultrasound 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 K252557
Lumify Diagnostic Ultrasound System
Philips Ultrasound, LLC
Image analysis/processing.
- Modality
- Ultrasound
- Anatomy
- N/A
- Decision
- 2025-12-22
FDA-cleared K252235
PVAD IQ Software
Ultrasight , Ltd.
Image analysis/processing.
- Modality
- Ultrasound
- Anatomy
- N/A
- Decision
- 2025-12-18
FDA-cleared K252294
Fetal EchoScan (v1.2)
Brightheart
Image analysis/processing.
- Modality
- Ultrasound
- Anatomy
- N/A
- Decision
- 2025-12-08