510(k) clearances

Rayvolve LN

AZmed · Radiology

K243831Substantially EquivalentTraditionalMYN
Open FDA's page for this record
Third party flag
N
City
Paris
Advisory committee description
Radiology
Address 1
10 Rue D'Uzès
Statement or summary
Summary
Product code
MYN
Zip code
75002
Applicant
AZmed
Decision date
2025-03-26
Decision code
SESE
Country code
FR
Device name
Rayvolve LN
Advisory committee
RA
Contact
Christelle Baille
K number
K243831
Date received
2024-12-13
Review advisory committee
RA
Postal code
75002
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Analyzer, Medical Image
Medical specialty description
Radiology
Regulation number
892.2070
Device class
2
Registration number
3038187462, 3038172231, 3029956998, 1226003, 3017840913, 3025110425, 3021907554, 3043237021, 3012035824, 3014661828, 3026753394, 3032960222, 8020825, 9611992, 3014398772, 3005496266, 3010300212, 3005739655, 3022719380, 3024891354, 3005156333, 3032116890, 3021887566, 3008693672, 3019544554, 3026970882, 3005383085, 3029904428
FEI number
3038187462, 3038172231, 3029956998, 7695, 3002522649, 3017840913, 3025110425, 3021907554, 3043237021, 3012035824, 3014661828, 3002807692, 3026753394, 3032960222, 3014398772, 3005496266, 3010300212, 3005739655, 3022719380, 3024891354, 3005156333, 3032116890, 3021887566, 3008693672, 3019544554, 3026970882, 3005383085, 3029904428
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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.