510(k) clearances

CINA-Aneurysm+

Avicenna.Ai · Radiology

K262147Substantially EquivalentTraditionalQIH
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
QIH
Zip code
13600
Applicant
Avicenna.Ai
Decision date
2026-10-19
Decision code
SESE
Country code
FR
Device name
CINA-Aneurysm+
Advisory committee
RA
Contact
Stéphane Berger
K number
K262147
Date received
2026-06-25
Review advisory committee
RA
Postal code
13600
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
3036502204, 3005403518, 1000432246, 9710090, 3018094310, 3028006458, 3008729547, 3006165260, 3025602618, 3017976149, 3015169361, 3017058304, 3010703925, 3008837339, 3003768277, 3018064242, 3044776706, 3015612252, 3010656400, 3019541896, 9680269, 3042248552, 3003899230, 3014310698, 3018302800, 1644408, 3025110425, 3030088963, 3031915908, 3023217364, 3010398867, 3011063460, 3016965352, 3002808157, 3004141078, 3016585383, 3020703662, 3006209933, 3019878658, 3008284470 +201 more
FEI number
3036502204, 3005403518, 1000432246, 3018094310, 3028006458, 3003405980, 3003310366, 3008729547, 3006165260, 3025602618, 3017976149, 3015169361, 3017058304, 3003309342, 3008837339, 3010703925, 3018064242, 3044776706, 3015612252, 3003408255, 3019541896, 3010656400, 3003899230, 3042248552, 3014310698, 3018302800, 3025110425, 3030088963, 3031915908, 3023217364, 3010398867, 3011063460, 3003377038, 3016965352, 3002808157, 3016585383, 3004141078, 3002808529, 3002808382, 3020703662 +201 more
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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.