Radiology AI Directory

Vendor

BK Medical Aps

2 FDA-cleared listings in this directory.

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FDA-cleared K231764

Ultrasound System 1300

BK Medical Aps

Ultrasound System 1300 is a diagnostic ultrasound system for the labeled clinical applications, probes, modes, and patient populations; the exact scope must be confirmed from the...

Modality
Ultrasound
Anatomy
Multi-region
Decision
2023-10-23
Ultrasound workflow
FDA-cleared K223830

Ultrasound System 2300

BK Medical Aps

Ultrasound System 2300 provides diagnostic ultrasound, fluid-flow analysis, and puncture or biopsy guidance across fetal and obstetric, abdominal, pediatric, intraoperative,...

Modality
Ultrasound
Anatomy
Multi-region
Decision
2023-04-11
Cardiac imagingUltrasound workflow