BEUDAMED

FDA UDI Not in Commercial Distribution 🇺🇸 United States

Senographe Essential Stereotaxy

DI: 00840682123297 · Model: EST6 · GE MEDICAL SYSTEMS

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Product Codes

1

GMDN Terms

1

Identifiers

1

Pkg Device Count

1

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Basic Information

Brand Name: Senographe Essential Stereotaxy
Primary DI: 00840682123297
Version / Model: EST6
Company Name: GE MEDICAL SYSTEMS
Labeler DUNS: 266062561
Distribution Status: Not in Commercial Distribution
Device Count in Pkg: 1
Record Status: Published
Publish Date: 2016-12-29
Public Version: 4
Public Version Date: 2025-07-02
Public Version Status: Update
Public Device Record Key: 9b731f49-0f4e-4ebd-b74c-3ee5d4d8cd22
Distribution End Date: 2020-12-31

Device Description

ESSENTIAL STEREOTIX CDRH INTERNATIONAL

Device Characteristics

Single Use: No
Prescription Use (Rx): Yes
Over the Counter (OTC): No
Kit: No
Combination Product: No
HCT/P: No
Contains NRL: No
Not Made with NRL: No
MRI Safety: Labeling does not contain MRI Safety Information
Direct Marking Exempt: No
PM Exempt: No
Has Serial Number: Yes
Has Lot/Batch Number: No
Has Manufacturing Date: Yes
Has Expiration Date: No
Has Donation ID: No

Sterilization

Is Sterile: No
Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
IZH	System, x-ray, mammographic	Radiology	892.1710	2

GMDN Terms

Code	Name	Definition	Implantable	Status
37672	Stationary mammographic x-ray system, digital	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	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00840682123297	GS1

Premarket Submissions

Submission Number	Supplement Number
K040125	000

Storage Conditions

Type: Storage Environment Atmospheric Pressure
Temperature Range: 50 – 106 KiloPascal
Type: Handling Environment Temperature
Temperature Range: -20 – 50 Degrees Celsius
Type: Storage Environment Humidity
Temperature Range: 5 – 95 Percent (%) Relative Humidity
Type: Handling Environment Atmospheric Pressure
Temperature Range: 50 – 106 KiloPascal
Type: Storage Environment Temperature
Temperature Range: -20 – 50 Degrees Celsius
Type: Handling Environment Humidity
Temperature Range: 5 – 95 Percent (%) Relative Humidity