510(k) clearance
qCT Lung (v1.0)
- 510(k) number
- K261517
- Applicant
- Qure.Ai Technologies Pvt. , Ltd.
- Decision date
- Sep 14, 2026
- Date received
- May 7, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- QDQ
- Device type
- Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer
- Device class
- Class II
- Regulation
- 21 CFR 892.2090
- Advisory committee
- Radiology
- Statement or summary
- Summary
- Third party
- N
- Location
- Mumbai, IN