510(k) clearances

BriefCase-Triage

Aidoc Medical , Ltd. · Radiology

K250248Substantially EquivalentSpecialQAS
Open FDA's page for this record
Third party flag
N
City
Tell-Aviv
Advisory committee description
Radiology
Address 1
3 Aminadav St.
Statement or summary
Summary
Product code
QAS
Zip code
6706703
Applicant
Aidoc Medical , Ltd.
Decision date
2025-02-14
Decision code
SESE
Country code
IL
Device name
BriefCase-Triage
Advisory committee
RA
Contact
Amalia Schreier
K number
K250248
Date received
2025-01-27
Review advisory committee
RA
Postal code
6706703
Decision description
Substantially Equivalent
Clearance type
Special
Harmonized identifiers (openFDA)
Device name
Radiological Computer-Assisted Triage And Notification Software
Medical specialty description
Radiology
Regulation number
892.2080
Device class
2
Registration number
3021915828, 3021032044, 3017604664, 3014938447, 3017840913, 3014665798, 3015763655, 3016727312, 3011205675, 3035495311, 3017210169, 3007301305, 3023702863, 3012453401, 3034656245, 3014678441, 3017489096, 3004977335, 3038177848
FEI number
3021915828, 3021032044, 3017604664, 3014938447, 3017840913, 3014665798, 3015763655, 3016727312, 3035495311, 3017210169, 3007301305, 3023702863, 3012453401, 3034656245, 3014678441, 3017489096, 3004977335, 3014269683, 3038177848
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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.