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Found 2 results

510(k) Data Aggregation

K Number

Device Name

OPTIMA XR120

Manufacturer

GE MEDICAL SYSTEMS, LLC

Date Cleared

2011-07-19

(71 days)

Product Code

IXL

Regulation Number

892.1670

Why did this record match?

Product Code :

IXL

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized

Intended Use

The Optima XR120 is indicated for use in generating radiographic images of human anatomy. It is intended for general-purpose diagnostic procedures. It is capable of generating images on film or digitally. This device is not intended for mammographic applications.

Device Description

Not Found

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K Number

Device Name

MD-1835

Manufacturer

FISCHER IMAGING CORP.

Date Cleared

1997-03-04

(95 days)

Product Code

IXL

Regulation Number

892.1670

Why did this record match?

Product Code :

IXL

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized

Intended Use

Device Description

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