510(k) clearances

ChestView US (1.1)

Gleamer · Radiology

K252486Substantially EquivalentTraditionalMYN
Open FDA's page for this record
Third party flag
N
City
Paris
Advisory committee description
Radiology
Address 1
47bis Rue Des Vinaigriers
Statement or summary
Summary
Product code
MYN
Zip code
75010
Applicant
Gleamer
Decision date
2026-09-09
Decision code
SESE
Country code
FR
Device name
ChestView US (1.1)
Advisory committee
RA
Contact
Antoine Tournier
K number
K252486
Date received
2025-08-07
Review advisory committee
RA
Postal code
75010
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
3026970882, 3022719380, 3008693672, 3029956998, 8020825, 1226003, 3005156333, 3014661828, 3010300212, 3043237021, 3021907554, 3032960222, 3038172231, 3005383085, 3025110425, 3005739655, 3032116890, 3024891354, 9611992, 3021887566, 3029904428, 3014398772, 3038187462, 3005496266, 3012035824, 3026753394, 3019544554, 3017840913
FEI number
7695, 3026970882, 3002807692, 3022719380, 3008693672, 3029956998, 3005156333, 3014661828, 3010300212, 3043237021, 3021907554, 3032960222, 3038172231, 3005383085, 3025110425, 3005739655, 3032116890, 3024891354, 3002522649, 3021887566, 3029904428, 3014398772, 3038187462, 3005496266, 3012035824, 3026753394, 3019544554, 3017840913
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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.