FDA-cleared K200921

qER

Qure.ai Technologies

Image analysis/processing.

Modality
CT/CTA
Anatomy
N/A
Decision
2020-06-17
FDA-cleared K211222

qER-Quant

Qure.ai Technologies

Image analysis/processing.

Modality
CT/CTA
Anatomy
N/A
Decision
2021-07-30
FDA-cleared K212690

qXR-BT

Qure.ai Technologies

Image analysis/processing.

Modality
X-ray/Radiography
Anatomy
N/A
Decision
2021-12-21
FDA-cleared K231805

qXR-LN

Qure.ai Technologies

Image analysis/processing.

Modality
X-ray/Radiography
Anatomy
N/A
Decision
2023-12-22
FDA-cleared K240740

qCT LN Quant

Qure.ai Technologies

Image analysis/processing.

Modality
CT/CTA
Anatomy
N/A
Decision
2024-08-16
FDA-cleared K251610

qER-CTA (v1.0)

Qure.ai Technologies

Image analysis/processing.

Modality
CT/CTA
Anatomy
N/A
Decision
2025-09-08