B-Scan
K-Number: K243227 · 2025-07-11
Decision Date2025-07-11
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
B-Scan is a medical device manufactured by Accutome, Inc. Doing Business AS Keeler USA. It received FDA 510(k) clearance on 2025-07-11 under approval number K243227. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the B-Scan?
B-Scan is a medical device that received FDA 510(k) clearance on 2025-07-11. It is manufactured by Accutome, Inc. Doing Business AS Keeler USA. The 510(k) number is K243227.
When was B-Scan approved by the FDA?
B-Scan received FDA 510(k) clearance on 2025-07-11, under approval number K243227.
What company makes B-Scan?
B-Scan is manufactured by Accutome, Inc. Doing Business AS Keeler USA.
What is the FDA product code for B-Scan?
The FDA product code for B-Scan is IYO.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.