Products/Solutions & AI/AIRA
Artificial Intelligence Renal Assessment
AIRA assists radiologists in assessing the kidneys on CT. It measures each kidney automatically, so the radiologist starts from a consistent measurement instead of a manual one.
FDA 510(k)-cleared indications
What AIRA is cleared to measure
On non-contrast CT KUB, AIRA measures, for each kidney:
Renal parenchymal volume
Cranio-caudal length
Interpolar parenchymal thickness
Clearance details
- 510(k) number
- K261677
- Cleared
- 15 September 2026
- Device class
- Class II
- Product code
- QIH
- Regulation
- 21 CFR 892.2050
- Modality
- Non-contrast CT KUB
- Europe
- CE mark, Class I
Other AIRA capabilities
Beyond the cleared indications
Renal calculi detection and measurement*
Detects renal calculi and reports their dimensions, volume and HU for characterisation.
* Not FDA-cleared. AIRA is not cleared for the detection or measurement of kidney stones. Calculi detection is not part of the FDA 510(k) clearance (K261677), which covers only the three kidney measurements listed above.
Built by Aramis
Developed in-house, by a team that reads CT every day.
AIRA was designed and built by the Aramis team of ML engineers, software developers and radiologists in India. It assists the radiologist; every finding is reviewed and every report is signed by a qualified doctor.
AIRA is a separate product from the AI-assist tools in Ocular. Those tools, including urinary stones on CT KUB, are not FDA-cleared.