B-Scan— 510(k) K243227

Name: FDA 510(k) clearance K243227
Creator: U.S. Food and Drug Administration
Published: 2025-07-11

Substantially Equivalent

Accutome, Inc. Doing Business AS Keeler USA

FDA 510(k) clearance K243227 for B-Scan, Substantially Equivalent on 2025-07-11. Applicant: Accutome, Inc. Doing Business AS Keeler USA. Device class: 2.

Clearance details

Applicant: Accutome, Inc. Doing Business AS Keeler USA
Product code: Code IYO
Device class: Class 2
Regulation: 21 CFR 892.1560
Advisory panel: Radiology
Date received: 2024-10-08
Decision date: 2025-07-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Malvern, PA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code IYO

product code IYO

Malfunction: 3,339
Total: 3,339

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.