510(k) clearances

SmartChest

Milvue · Radiology

K232410Substantially EquivalentTraditionalQFM
Open FDA's page for this record
Third party flag
N
City
Paris
Advisory committee description
Radiology
Address 1
29 Rue Du Faubourg Saint Jacques
Statement or summary
Summary
Product code
QFM
Zip code
75014
Applicant
Milvue
Decision date
2024-05-10
Decision code
SESE
Country code
FR
Device name
SmartChest
Advisory committee
RA
Contact
Oumaya Ibrahim
K number
K232410
Date received
2023-08-10
Review advisory committee
RA
Postal code
75014
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Radiological Computer-Assisted Prioritization Software For Lesions
Medical specialty description
Radiology
Regulation number
892.2080
Device class
2
Registration number
3021032044, 3007734888, 3024844299, 3017604664, 3014938447, 3017840913, 3014665798, 3011205675, 3034205378, 3018733944, 9616047, 3030491946, 3023702863, 3012453401, 3005156333, 3029915548, 3034656245, 3014678441, 3021230777, 3017173128, 3027453703, 2126677
FEI number
3021032044, 3007734888, 3024844299, 3017604664, 3014938447, 3017840913, 3003377038, 3014665798, 3034205378, 3018733944, 3030491946, 3023702863, 3012453401, 3005156333, 3029915548, 3034656245, 3014678441, 3021230777, 3017173128, 3027453703, 3014269683, 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.