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510(k) Data Aggregation

K Number

Device Name

B-Scan

Manufacturer

ACCUTOME, INC. Doing Business As Keeler USA

Date Cleared

2025-07-11

(276 days)

Product Code

IYO

Regulation Number

892.1560

Why did this record match?

Applicant Name (Manufacturer) :

ACCUTOME, INC. Doing Business As Keeler USA

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized

Intended Use

Device Description

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