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510(k) Data Aggregation

K Number

Device Name

JANUS I

Manufacturer

3D ULTRASOUND, INC.

Date Cleared

1997-04-21

(207 days)

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Regulation Number

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Applicant Name (Manufacturer) :

3D ULTRASOUND, INC.

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty

Intended Use

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