Prodigy

Basic Information

• Brand Name: Prodigy
• Primary DI: 00840682117098
• Version / Model: F1
• Company Name: GE MEDICAL SYSTEMS, ULTRASOUND & PRIMARY CARE DIAGNOSTICS, LLC
• Labeler DUNS: 078863378
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-06-27
• Public Version: 5
• Public Version Date: 2019-12-06
• Public Version Status: Update
• Public Device Record Key: bc7c1f5e-ad35-4a2d-b008-2d2fddaa4ea3

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
KGI	Densitometer, bone	Radiology	892.1170	2

GMDN Terms

Code	Name	Definition	Implantable	Status
37661	Bone absorptiometric x-ray system, dual-energy	An assembly of devices designed for bone density measurements and other calculations based on data obtained using a two distinct photon energy peak. Also referred to as a bone densitometer. It utilizes an x-ray tube or tubes as the photon source which are mechanically aligned and moves along with a photon detector assembly typically in a rectilinear pattern. The collimated beam is directed through an anatomical region of interest and the differential absorption patterns are detected. This information is used in calculations to estimate bone mineral density (osteoporosis), subcutaneous fat, fracture risk.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00840682117098	GS1

Premarket Submissions

Submission Number	Supplement Number
K133664	000
K161682	000
K191112	000
K982267	000

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: 18 – 27 Degrees Celsius
• Type: Storage Environment Atmospheric Pressure
• Temperature Range: 50 – 106 KiloPascal
• Type: Storage Environment Temperature
• Temperature Range: -30 – 65 Degrees Celsius
• Type: Handling Environment Humidity
• Temperature Range: 20 – 80 Percent (%) Relative Humidity
• Type: Storage Environment Humidity
• Temperature Range: 0 – 95 Percent (%) Relative Humidity