Senographe Pristina

Senographe Pristina - EKB1

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

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: IWX

Device Name: Barrier, Control Panel, X-Ray, Movable

Device Class: 1

Physical State: N/A

Definition: N/A

Submission Type ID: 4

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: 892.6500

Third Party Flag: N

Medical Specialty: RA

Code: ITY

Device Name: Assembly, Tube Housing, X-Ray, Diagnostic

Device Class: 1

Physical State: N/A

Definition: N/A

Submission Type ID: 4

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: 892.1760

Third Party Flag: N

Medical Specialty: RA

Code: FMQ

Device Name: Restraint, Protective

Device Class: 1

Physical State: N/A

Definition: N/A

Submission Type ID: 4

Review Panel: HO

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: 880.6760

Third Party Flag: N

Medical Specialty: HO

Code: IZO

Device Name: Generator, High-Voltage, X-Ray, Diagnostic

Device Class: 1

Physical State: N/A

Definition: N/A

Submission Type ID: 4

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: 892.1700

Third Party Flag: N

Medical Specialty: RA

Code: IXJ

Device Name: Grid, Radiographic

Device Class: 1

Physical State: N/A

Definition: N/A

Submission Type ID: 4

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: 892.1910

Third Party Flag: N

Medical Specialty: RA

Code: IZW

Device Name: Collimator, Automatic, Radiographic

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 4

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: 892.1610

Third Party Flag: N

Medical Specialty: RA

Device Id: 00840682118460

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