MiPACS V5 (1.0.0)— 510(k) K260231

Name: FDA 510(k) clearance K260231
Creator: U.S. Food and Drug Administration
Published: 2026-06-25

Substantially Equivalent

Apryse Software Corp

FDA 510(k) clearance K260231 for MiPACS V5 (1.0.0), Substantially Equivalent on 2026-06-25. Applicant: Apryse Software Corp. Device class: 2.

Summary

MiPACS V5 (1.0.0) from Apryse Software is filed under LLZ, radiological image processing systems. The record doesn't expand the name or describe the system beyond the code name.

Class II, 21 CFR 892.2050. Radiology is both the classification panel and the review panel. It came in as a Traditional 510(k).

Apryse filed from Denver, Colorado. The decision came 150 calendar days after receipt (January 26 to June 25, 2026).

Clearance details

Applicant: Apryse Software Corp
Product code: Product code LLZ
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2026-01-26
Decision date: 2026-06-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Denver, CO, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LLZ

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K263048 — Syngo Carbon Space (VA4)2026-09-29
K261874 — Syneris PACS v.1.0.1.02026-09-23
K262442 — HipStudio Analysis2026-09-22
K261855 — Elucid PlaqueIQ2026-09-18
K254214 — OOOPDS2026-09-15

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.