Brightheart radiology AI products

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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?

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Radiology AI pricing and total cost of ownership

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FDA-cleared K252294

Fetal EchoScan (v1.2)

Brightheart

Authorized purpose: Concurrent CADx aid for suspicious fetal cardiac morphological findings during second-trimester fetal heart ultrasound.

Modality: Ultrasound
Anatomy: Fetal Heart / Obstetric
Decision: 2025-12-08

FDA-cleared K251456

BrightHeart View Classifier

BrightHeart

Authorized purpose: Automatic standard-view classification, frame extraction, and acquisition-protocol assessment during second- or third-trimester fetal ultrasound.

Modality: Ultrasound
Anatomy: Fetal heart and abdomen standard views during fetal anatomic ultrasound
Decision: 2025-06-05

Cardiac imaging Ultrasound workflow

FDA-cleared K243684

BrightHeart View Classifier

BrightHeart

Authorized purpose: Automatic standard-view detection and frame extraction to support acquisition and interpretation of second- or third-trimester fetal heart ultrasound.

Modality: Ultrasound
Anatomy: Obstetric/Fetal
Decision: 2025-05-07

Cardiac imaging Detection and CADe Ultrasound workflow

FDA-cleared K251071

Fetal EchoScan (v1.1)

BrightHeart

Authorized purpose: Adjunctive detection of suspicious fetal cardiac findings during second-trimester ultrasound to aid concurrent OB-GYN or maternal-fetal-medicine interpretation.

Modality: Ultrasound
Anatomy: Fetal heart, including four-chamber, left-ventricular-outflow-tract, and right-ventricular-outflow-tract views and the specified suspicious cardiac findings
Decision: 2025-05-02

Cardiac imaging Detection and CADe Ultrasound workflow

FDA-cleared K242342

Authorized purpose: Adjunctive CADx aid for interpreting OB-GYN/MFM physicians to identify suspicious fetal-cardiac findings in second-trimester anatomic ultrasound that may suggest congenital heart defects and inform the need for additional exams.

Modality: Ultrasound
Anatomy: Fetal heart, including the cardiac crux, outflow tracts, cardiac axis, ventricles, and valve annular relationships.
Decision: 2024-11-14

Cardiac imaging Detection and CADe Ultrasound workflow