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510(k) Data Aggregation

K Number

Validate with FDA (Live)

Device Name

VITREA 2, VERSION 2.1

Manufacturer

VITAL IMAGES, INC.

Date Cleared

2000-10-19

(65 days)

Product Code

Regulation Number

Type

Panel

Age Range

N/A

Reference & Predicate Devices

N/A

Predicate For

K012563,K020658,K022789,K022938,K031779,K031871,K032483,K032748,K033361,K040126,K040746,K041286,K091498

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

Device Description

AI/ML Overview

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