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FDA-cleared K233582

Rapid

iSchema View Inc.

Authorized purpose: Rapid is image-viewing, processing, and analysis software for DICOM CT, CT perfusion, CT angiography, C-arm CT perfusion, and MRI data, including perfusion maps and acute-stroke selection support under the labeled occlusion and imaging criteria.

Modality
Radiological images; modality varies or is not specified in FDA list
Anatomy
Brain, cerebral vasculature, and perfusion regions
Decision
2024-04-22
FDA-cleared K223396

Rapid RV/LV

iSchema View Inc.

Authorized purpose: Adjunctive measurement of the RV/LV ratio as a clinical metric used by medical professionals to quantify severity of right-heart strain in adults evaluated with CTPA; the annotated measurements support, but do not replace, clinical assessment.

Modality
CT/CTA
Anatomy
Heart/Cardiovascular
Decision
2023-02-01
FDA-cleared K213165

Rapid

iSchema View Inc.

Authorized purpose: Rapid processes CT, CTP, CTA, diffusion MRI, and dynamic-contrast MRI for stroke viewing, perfusion, volumetry, mismatch, and large-vessel-density support for trained professionals.

Modality
Radiological images; modality varies or is not specified in FDA list
Anatomy
Brain
Decision
2022-02-08