510(k) clearances

Rayvolve AZchest

AZmed · Radiology

K261378Substantially EquivalentTraditionalQBS
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
QBS
Zip code
75002
Applicant
AZmed
Decision date
2026-08-28
Decision code
SESE
Country code
FR
Device name
Rayvolve AZchest
Advisory committee
RA
Contact
Victor DE POLLI
K number
K261378
Date received
2026-04-27
Review advisory committee
RA
Postal code
75002
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
3027453703, 9616047, 3014661828, 3007734888, 3021907554, 2126677, 3026753394, 3013427569
FEI number
3027453703, 3014661828, 3007734888, 3021907554, 2126677, 3026753394, 3003377038, 3013427569
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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.