510(k) clearances

a2z-Abdo-Triage

A2z Radiology Ai, Inc. · Radiology

K260906Substantially EquivalentTraditionalQAS
Open FDA's page for this record
Third party flag
N
City
Boston
Advisory committee description
Radiology
Address 1
292 Newbury St.
Address 2
Unit 235
Statement or summary
Summary
Product code
QAS
Zip code
02115
Applicant
A2z Radiology Ai, Inc.
Decision date
2026-09-16
Decision code
SESE
Country code
US
Device name
a2z-Abdo-Triage
Advisory committee
RA
Contact
Samir Rajpurkar
K number
K260906
State
MA
Date received
2026-03-19
Review advisory committee
RA
Postal code
02115
Decision description
Substantially Equivalent
Clearance type
Traditional
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
3004977335, 3017604664, 3034656245, 3021032044, 3007301305, 3017210169, 3011205675, 3016727312, 3038177848, 3023702863, 3014665798, 3012453401, 3015763655, 3014678441, 3021915828, 3017489096, 3035495311, 3014938447, 3017840913
FEI number
3004977335, 3017604664, 3034656245, 3021032044, 3007301305, 3017210169, 3016727312, 3038177848, 3023702863, 3014269683, 3014665798, 3012453401, 3015763655, 3014678441, 3021915828, 3017489096, 3035495311, 3014938447, 3017840913
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.