510(k) clearances

ChestView US

Gleamer Sas · Radiology

K241620Substantially 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 Sas
Decision date
2025-02-27
Decision code
SESE
Country code
FR
Device name
ChestView US
Advisory committee
RA
Contact
Antoine Tournier
K number
K241620
Date received
2024-06-05
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
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
Wholesale access for licensed clinicians.

Free to join: your NPI is checked against the federal registry at signup, then wholesale pricing and the professional shelves open.

Join as a DoctorSell on MedGrid

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.