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510(k) Data Aggregation

K Number

Device Name

IMAGE ONE

Manufacturer

Infomed Software, S.L.

Date Cleared

2025-07-23

(135 days)

Product Code

LLZ

Regulation Number

892.2050

Why did this record match?

Applicant Name (Manufacturer) :

Infomed Software, S.L.

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized

Intended Use

Device Description

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