510(k) clearances

Artificial Intelligence Renal Assessment (AIRA) Version 1

Aramis Global AI Consultancies, LLC · Radiology

K261677Substantially EquivalentTraditionalQIH
Open FDA's page for this record
Third party flag
N
City
Dubai
Advisory committee description
Radiology
Address 1
Rahet Albal Business Centre
Address 2
Ct. Tower Bldg., Office #39
Statement or summary
Summary
Product code
QIH
Applicant
Aramis Global AI Consultancies, LLC
Decision date
2026-09-15
Decision code
SESE
Country code
AE
Device name
Artificial Intelligence Renal Assessment (AIRA) Version 1
Advisory committee
RA
Contact
Anil Prahladan
K number
K261677
Date received
2026-05-21
Review advisory committee
RA
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Automated Radiological Image Processing Software
Medical specialty description
Radiology
Regulation number
892.2050
Device class
2
Registration number
8043836, 3019844085, 3016461002, 8022257, 3013410552, 3019541896, 3033527283, 3008693672, 3013552417, 3017210169, 3003594449, 1000432246, 9710090, 3020928588, 9616047, 3040335643, 3015516266, 9617277, 3030655434, 3010952312, 3001722928, 3015612252, 3042243683, 3038177848, 3042902406, 3007630531, 3033508292, 3019216, 3015425142, 3017167291, 3012981490, 3010885402, 3029915548, 3017426576, 3045078825, 3014146081, 3025110425, 3042248552, 9616251, 2936485 +197 more
FEI number
3019844085, 3016461002, 3013410552, 3019541896, 3002807692, 3003309342, 3033527283, 3008693672, 3002087856, 3010289997, 3013552417, 3003594449, 3017210169, 1000432246, 3002807880, 3020928588, 3040335643, 3015516266, 3030655434, 3007630531, 3010952312, 3001722928, 3015612252, 3042243683, 3038177848, 3042902406, 3003190524, 3033508292, 3019216, 3015425142, 3017167291, 3012981490, 3010885402, 3029915548, 3017426576, 3045078825, 3014146081, 3025110425, 3042248552, 2936485 +197 more
Wholesale access for licensed clinicians.

Free to join: your NPI is checked against the federal registry at signup, then wholesale pricing and the professional shelves open.

Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.