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Found 1 results

510(k) Data Aggregation

K Number

Device Name

NOVALIS (SHAPED BEAM SURGERY SYSTEM)

Manufacturer

Date Cleared

2000-11-03

(80 days)

Product Code

Regulation Number

Type

Panel

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N/A

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Device Name :

NOVALIS (SHAPED BEAM SURGERY SYSTEM)

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

Device Description

AI/ML Overview

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