SpectoMed (v1.0)— 510(k) K242205

Name: FDA 510(k) clearance K242205
Creator: U.S. Food and Drug Administration
Published: 2025-01-14

Substantially Equivalent

Specto Medical

FDA 510(k) clearance K242205 for SpectoMed (v1.0), Substantially Equivalent on 2025-01-14. Applicant: Specto Medical. Device class: 2.

Clearance details

Applicant: Specto Medical
Product code: Code LLZ
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2024-07-26
Decision date: 2025-01-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Basel, CH

Download summary PDF View on FDA.gov ↗

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K261500 — KBA3D (v2.4.0)2026-08-17

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.