Software Pristina 8.1 - ISO file

Software Pristina 8.1
not applicable - PRISTINA 2.8

A stationary assembly of devices designed to generate x-ray images of the breast using digital techniques for image capture and display. It is designed specifically to compress the breast during imaging and is intended to visually evaluate the anatomy and function of blood and lymphatic vessels within the breast. Often referred to as a digital mammography system (DMS) it is typically used for breast cancer screening or during biopsy procedures (e.g., placement of biopsy markers, stereotactic biopsy). It is designed to capture two-dimensional (2-D) x-ray images, however may include software intended to process multiple images to create a three-dimensional (3-D) image/model (tomosynthesis).

No Data Available

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

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

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

Device Id: 00195278560049

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