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Found 2 results

510(k) Data Aggregation

K Number

Device Name

OIS-2500 DIAGNOSTIC ULTRASOUND SYSTEM

Manufacturer

OPTIMAL IMAGING SYSTEMS, INC.

Date Cleared

2000-04-11

(63 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

N/A

Predicate For

N/A

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

Device Description

AI/ML Overview

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K Number

Device Name

OIS-STAND ALONE DIAGNOSTIC ULTRASOUND SYSTEM

Manufacturer

OPTIMAL IMAGING SYSTEMS, INC.

Date Cleared

2000-02-24

(49 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

N/A

Predicate For

N/A

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

Device Description

AI/ML Overview

Ask a Question

Ask a specific question about this device

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