510(k) clearances

Avatar Medical Vision

Avatar Medical · Radiology

K253950Substantially EquivalentTraditionalLLZ
Open FDA's page for this record
Third party flag
N
City
Paris
Advisory committee description
Radiology
Address 1
11 Rue Lourmel
Statement or summary
Summary
Product code
LLZ
Zip code
75015
Applicant
Avatar Medical
Decision date
2026-03-30
Decision code
SESE
Country code
FR
Device name
Avatar Medical Vision
Advisory committee
RA
Contact
Adeline Francois
K number
K253950
Date received
2025-12-10
Review advisory committee
RA
Postal code
75015
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
System, Image Processing, Radiological
Medical specialty description
Radiology
Regulation number
892.2050
Device class
2
Registration number
3003412859, 3036725840, 3023217364, 8043933, 3016851379, 3021637148, 3010132318, 3026391019, 3045159436, 9615992, 3023266032, 3017936978, 3017489096, 3003768277, 3003402534, 3004526608, 3048085746, 3008027912, 1826555, 3006115340, 3004884150, 9614977, 3007137598, 3006990600, 1717344, 3017435704, 3025308066, 3012322232, 1000432246, 3011114764, 3009238185, 3004063527, 3014055202, 3013077751, 3010656400, 3006551157, 3006551230, 3011724582, 3009134655, 3010687441 +600 more
FEI number
3003405980, 3003412859, 3036725840, 3023217364, 3016851379, 3021637148, 3010132318, 3026391019, 3045159436, 3023266032, 3017936978, 3017489096, 3003402534, 1826555, 3004526608, 3048085746, 3008027912, 3006115340, 3004884150, 3007137598, 3006990600, 1717344, 3017435704, 3025308066, 3012322232, 1000432246, 3011114764, 3009238185, 3004063527, 3003719498, 3014055202, 3013077751, 3010656400, 3006551157, 3006551230, 3011724582, 3009134655, 3010687441, 3000219976, 3008962159 +600 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.