Software Pristina 8.2 - ISO file


Product Overview

Software Pristina 8.2
not applicable - PRISTINA 2.8.2


Device Description

A device that can only fulfil its purpose when used together with and enhance the function of a diagnostic mammographic x-ray system. It is used to take two pictures of a breast from two different angles. On the basis of this stereoscopic picture set, it is possible to determine the exact position of a lesion in the breast and a cytological sample of this will be taken. This device or technique may be built-in to some diagnostic x-ray systems for mammography.


Environmental Conditions

No Data Available


Device Sizes

No Data Available


Device Sterilization

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available


Product Codes

Code: OTE

Device Name: Digital Breast Tomosynthesis

Device Class: 3

Physical State: Hardware and software for acquiring and reconstructing digital projection images. May incorporate similar equipment as full-field digital mammography systems.

Definition: To generate digital 3D mammographic images that can be used for the screening and diagnosis of breast cancer.

Submission Type ID: 2

Review Panel: RA

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: Projection images are acquired over the stationary breast and reconstructed to produce cross-sectional ┬┐slices┬┐ through the breast.

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: Breast

Regulation Number: N/A

Third Party Flag: N

Medical Specialty: N/A


Code: MUE

Device Name: Full Field Digital, System, X-Ray, Mammographic

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 1

Review Panel: RA

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: N/A

Regulation Number: 892.1715

Third Party Flag: Y

Medical Specialty: RA


Device Identifiers

Device Id: 00195278655141

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A


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