HipStudio Analysis— 510(k) K262442

Name: FDA 510(k) clearance K262442
Creator: U.S. Food and Drug Administration
Published: 2026-09-22

Substantially Equivalent

Replasia BV

FDA 510(k) clearance K262442 for HipStudio Analysis, Substantially Equivalent on 2026-09-22. Applicant: Replasia BV. Device class: 2.

Summary

HipStudio Analysis from Replasia BV is filed under LLZ, radiological image processing systems. The name points to hip imaging analysis, but the record doesn't describe the measurements or outputs.

Class II, 21 CFR 892.2050. The Radiology panel reviewed it as a Traditional 510(k).

Replasia filed from Leuven, Belgium. Review took 68 days (July 16 to September 22, 2026).

Clearance details

Applicant: Replasia BV
Product code: Product code LLZ
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2026-07-16
Decision date: 2026-09-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Leuven, BE

Download summary PDF View on FDA.gov ↗

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Adverse events under product code LLZ

product code LLZ

Death: 13
Total: 13

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.