510(k) clearances

qCT Lung (v1.0)

Qure.Ai Technologies Pvt. , Ltd. · Radiology

K261517Substantially EquivalentTraditionalQDQ
Open FDA's page for this record
Third party flag
N
City
Mumbai
Advisory committee description
Radiology
Address 1
6th Floor, Wing E, Times Sq., Andheri- Kurla Rd., Marol
Address 2
Andheri (East)
Statement or summary
Summary
Product code
QDQ
Zip code
400059
Applicant
Qure.Ai Technologies Pvt. , Ltd.
Decision date
2026-09-14
Decision code
SESE
Country code
IN
Device name
qCT Lung (v1.0)
Advisory committee
RA
Contact
Smina T P
K number
K261517
Date received
2026-05-07
Review advisory committee
RA
Postal code
400059
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer
Medical specialty description
Radiology
Regulation number
892.2090
Device class
2
Registration number
3016819165, 3018733944, 3021230777, 3026970882, 3042248552, 3005496266, 3030412475, 3016759115, 3015173173, 3023522713, 3025343020
FEI number
3016819165, 3018733944, 3021230777, 3026970882, 3042248552, 3005496266, 3030412475, 3016759115, 3015173173, 3023522713, 3025343020
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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.