ADAS 3D— 510(k) K253969
Substantially EquivalentAdas3D Medical S.L.
FDA 510(k) clearance K253969 for ADAS 3D, Substantially Equivalent on 2026-06-29. Applicant: Adas3D Medical S.L.. Device class: 2.
Summary
ADAS 3D from Adas3D Medical is filed under QIH, automated radiological image processing software. The record doesn't expand the name or describe the processing it performs.
Class II, 21 CFR 892.2050. Radiology is both the classification panel and the review panel, and the submission was a Traditional 510(k).
Adas3D filed from Barcelona, Spain. Review took 200 calendar days (December 11, 2025 to June 29, 2026).
Clearance details
- Applicant
- Adas3D Medical S.L.
- Product code
- Product code QIH
- Device class
- Class 2
- Regulation
- 21 CFR 892.2050
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Barcelona, ES
Recent devices under product code QIH
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