ERGO Localizer

Basic Information

• Brand Name: ERGO Localizer
• Primary DI: 00858164002213
• Version / Model: ERGO Localizer
• Company Name: ELEKTA, INC.
• Labeler DUNS: 079089435
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-11-10
• Public Version: 6
• Public Version Date: 2022-11-14
• Public Version Status: Update
• Public Device Record Key: 10da6a3d-c092-4b44-9250-fd891b5edfed

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• 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
MUJ	System,Planning,Radiation Therapy Treatment	Radiology	892.5050	2

GMDN Terms

Code	Name	Definition	Implantable	Status
40887	Radiation therapy software	An application software program intended to facilitate/support the delivery of therapeutic radiation by enabling computer-assisted functionality in one or more of the following areas: treatment planning, simulation, record/verify, beam block CAD/CAM, quality assurance, and patient positioning. Some types may be combined with specific hardware or firmware accessories or configurations in order to function as intended.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00858164002213	GS1

Premarket Submissions

Submission Number	Supplement Number
K080601	000