VELYS Hip Navigation— 510(k) K253551
Substantially EquivalentDepuy Ireland UC
FDA 510(k) clearance K253551 for VELYS Hip Navigation, Substantially Equivalent on 2026-03-06. Applicant: Depuy Ireland UC. Device class: 2.
Summary
Depuy Ireland's VELYS Hip Navigation is filed under QIH, automated radiological image processing software. The record doesn't describe the software beyond its name and that code name.
Class II, 21 CFR 892.2050. Radiology is both the classification panel and the review panel. It was a Traditional 510(k).
Depuy Ireland filed from Ringaskiddy, Co. Cork, Ireland. The decision came 112 calendar days after receipt (November 14, 2025 to March 6, 2026).
Clearance details
- Applicant
- Depuy Ireland UC
- 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
- Ringaskiddy, Co. Cork, IE
Recent devices under product code QIH
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