510(k) clearances

CINA-Aneurysm

Avicenna.Ai · Radiology

K262062Substantially EquivalentTraditionalQBS
Open FDA's page for this record
Third party flag
N
City
La Ciotat
Advisory committee description
Radiology
Address 1
Espace Mistral B, 375 Ave. Du Mistral
Statement or summary
Summary
Product code
QBS
Zip code
13600
Applicant
Avicenna.Ai
Decision date
2026-10-20
Decision code
SESE
Country code
FR
Device name
CINA-Aneurysm
Advisory committee
RA
Contact
Stéphane Berger
K number
K262062
Date received
2026-06-18
Review advisory committee
RA
Postal code
13600
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Radiological Computer Assisted Detection/Diagnosis Software For Fracture
Medical specialty description
Radiology
Regulation number
892.2090
Device class
2
Registration number
3014661828, 3026753394, 3007734888, 3021907554, 3027453703, 3013427569, 2126677, 9616047
FEI number
3014661828, 3026753394, 3007734888, 3021907554, 3003377038, 3027453703, 3013427569, 2126677
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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.