510(k) clearances

Fetal EchoScan (v1.1)

Brightheart · Radiology

K251071Substantially EquivalentSpecialPOK
Open FDA's page for this record
Third party flag
N
City
Paris
Advisory committee description
Radiology
Address 1
7-11 Blvd. Haussmann
Statement or summary
Summary
Product code
POK
Zip code
75009
Applicant
Brightheart
Decision date
2025-05-02
Decision code
SESE
Country code
FR
Device name
Fetal EchoScan (v1.1)
Advisory committee
RA
Contact
Christophe Gardella
K number
K251071
Date received
2025-04-07
Review advisory committee
RA
Postal code
75009
Decision description
Substantially Equivalent
Clearance type
Special
Harmonized identifiers (openFDA)
Device name
Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer
Medical specialty description
Radiology
Regulation number
892.2060
Device class
2
Registration number
3034527804, 3040335643, 3007301305, 3015478020, 3022983474, 3029937167, 3017210169, 3010119782, 3044622018, 3033588305, 3017604664, 3032008018, 3016585383, 3011205675, 3019216, 2518586
FEI number
3034527804, 3040335643, 3007301305, 3015478020, 3022983474, 3029937167, 3017210169, 3010119782, 3044622018, 3033588305, 3017604664, 3014269683, 3032008018, 3016585383, 3019216, 2518586
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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.