myQA iON— 510(k) K201798

Substantially Equivalent

Iba Dosimetry GmbH

FDA 510(k) clearance K201798 for myQA iON, Substantially Equivalent on 2020-07-17. Applicant: Iba Dosimetry GmbH. Device class: 2.

Clearance details

Applicant: Iba Dosimetry GmbH
Product code: Code LHN
Device class: Class 2
Regulation: 21 CFR 892.5050
Advisory panel: Radiology
Date received: 2020-06-30
Decision date: 2020-07-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Schwarzenbruck, DE

Download summary PDF View on FDA.gov ↗

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Recalls naming K201798

K-number listed on FDA's recall record

Z-1703-2025 — myQA iON; Article Number: MQ10-000;Class II·Ongoing·IBA Dosimetry GmbH·20250401

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K201798.

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