Cleared Traditional

B-Scan

K243227 · Accutome, Inc. Doing Business AS Keeler USA · Radiology

Jul 2025

Decision

276d

Days

Class 2

Risk

About This 510(k) Submission

K243227 is an FDA 510(k) clearance for the B-Scan, a System, Imaging, Pulsed Echo, Ultrasonic (Class II — Special Controls, product code IYO), submitted by Accutome, Inc. Doing Business AS Keeler USA (Malvern, US). The FDA issued a Cleared decision on July 11, 2025, 276 days after receiving the submission on October 8, 2024. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1560.

Submission Details

510(k) Number	K243227 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 08, 2024
Decision Date	July 11, 2025
Days to Decision	276 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF