BK Medical Aps radiology AI products

Turn this list into an evaluation

Each entry is an FDA submission, not a distinct commercial offer. Inspect the exact record before comparing evidence, asking for a quote or planning an integration.

Which exact product, version and licensed modules are in the current offer?
Do related FDA submissions document the same scope, or different functions and versions?
Which costs, support obligations and local acceptance tests remain unresolved?

Prepare with a buyer guide:

Radiology AI pricing and total cost of ownership

Clinical guide links appear when this list contains a current reviewed example. They do not classify or endorse the other entries. All buyer guides · Compare exact records · Documented families

FDA-cleared K231764

Ultrasound System 1300

BK Medical Aps

Authorized purpose: 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 submission labeling.

Modality: Ultrasound
Anatomy: Multi-region
Decision: 2023-10-23

Ultrasound workflow

FDA-cleared K223830

Ultrasound System 2300

BK Medical Aps

Authorized purpose: Ultrasound System 2300 provides diagnostic ultrasound, fluid-flow analysis, and puncture or biopsy guidance across fetal and obstetric, abdominal, pediatric, intraoperative, small-organ, cardiac, transesophageal, vascular, musculoskeletal, thoracic, and transrectal or transvaginal applications; it is not for ophthalmic imaging or through-the-eye use.

Modality: Ultrasound
Anatomy: Multi-region
Decision: 2023-04-11

Cardiac imaging Ultrasound workflow