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510(k) Data Aggregation

K Number

Device Name

KODAK CARDIOLOGY DIGITAL ARCHIVE & REVIEW SYSTEM

Manufacturer

JAMIESON FILM CO.

Date Cleared

1996-03-27

(84 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

N/A

Why did this record match?

Device Name :

KODAK CARDIOLOGY DIGITAL ARCHIVE & REVIEW SYSTEM

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

Not Found

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text is a 510(k) clearance letter for the Kodak Cardiology Digital Archive and Review System. It does not contain any information about acceptance criteria, study design, or performance metrics. Therefore, I cannot fulfill your request based on the given input.

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