510(k) clearances

aiCockpit AI Viewer

Fovia, Inc. · Radiology

K241546Substantially EquivalentTraditionalLLZ
Open FDA's page for this record
Third party flag
N
City
Ross
Advisory committee description
Radiology
Address 1
P.O. Box 1858
Statement or summary
Summary
Product code
LLZ
Zip code
94957
Applicant
Fovia, Inc.
Decision date
2025-02-26
Decision code
SESE
Country code
US
Device name
aiCockpit AI Viewer
Advisory committee
RA
Contact
Paula Brown
K number
K241546
State
CA
Date received
2024-05-31
Review advisory committee
RA
Postal code
94957
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
System, Image Processing, Radiological
Medical specialty description
Radiology
Regulation number
892.2050
Device class
2
Registration number
3001052305, 3005406110, 3017545364, 3005172103, 9617978, 3004706313, 3008487708, 1226544, 3009341091, 3044776706, 3010656400, 3038189169, 3007362683, 3007993775, 1061158, 3014232555, 3003757027, 3014991167, 9617592, 3013634985, 3023217364, 1054415, 3013535906, 3026047529, 3019878658, 3005225421, 3030655434, 3009156722, 3010445368, 8020825, 3011676026, 3008364043, 3045521711, 3014635169, 2954921, 9615439, 3011015597, 3003989064, 3035371452, 3019544554 +603 more
FEI number
3001052305, 3005406110, 3017545364, 3005172103, 3004706313, 3008487708, 3009341091, 3044776706, 3002808188, 3010656400, 3038189169, 3007362683, 3007993775, 3014232555, 3003757027, 3014991167, 3013634985, 3023217364, 3013535906, 3026047529, 3019878658, 3005225421, 3030655434, 3009156722, 3010445368, 3011676026, 3008364043, 3045521711, 3014635169, 3011015597, 3003989064, 3035371452, 3019544554, 3008548323, 3014269683, 3002821504, 2126677, 3002619595, 3010684280, 3003861317 +603 more
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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.