Precise Treatment Table™

Basic Information

• Brand Name: Precise Treatment Table™
• Primary DI: 05060191071086
• Version / Model: 1526779
• Company Name: ELEKTA LIMITED
• Labeler DUNS: 525557559
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 5
• Public Version Date: 2022-11-14
• Public Version Status: Update
• Public Device Record Key: de88c0c1-3d7b-4b75-90c8-5c52bb166daf

Device Description

Precise Treatment Table

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
IYE	Accelerator, linear, medical	Radiology	892.5050	2

GMDN Terms

Code	Name	Definition	Implantable	Status
40683	Therapeutic x-ray system table, powered	A powered/programmable radiotherapy table specifically designed to position and support a patient during treatments administered using a therapeutic x-ray system. It has electronic and/or software controls for table top height and positioning. It can be a stationary or mobile unit, or incorporated as an integral component of a therapeutic x-ray system design.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05060191071086	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K983678	000