510(k) clearances

Brainomix 360 e-ASPECTS

Brainomix Limited · Radiology

K243294Substantially EquivalentTraditionalPOK
Open FDA's page for this record
Third party flag
N
City
Oxford
Advisory committee description
Radiology
Address 1
First Floor Seacourt Tower
Address 2
West Way
Statement or summary
Summary
Product code
POK
Zip code
OX2 0JJ
Applicant
Brainomix Limited
Decision date
2025-02-14
Decision code
SESE
Country code
GB
Device name
Brainomix 360 e-ASPECTS
Advisory committee
RA
Contact
Delanyo Mensah
K number
K243294
Date received
2024-10-18
Review advisory committee
RA
Postal code
OX2 0JJ
Decision description
Substantially Equivalent
Clearance type
Traditional
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
3032008018, 2518586, 3044622018, 3022983474, 3010119782, 3011205675, 3029937167, 3033588305, 3034527804, 3017604664, 3017210169, 3015478020, 3007301305, 3019216, 3016585383, 3040335643
FEI number
3032008018, 2518586, 3044622018, 3022983474, 3010119782, 3019216, 3029937167, 3033588305, 3034527804, 3017604664, 3017210169, 3015478020, 3007301305, 3014269683, 3016585383, 3040335643
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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.