ACTEON

Basic Information

• Brand Name: ACTEON
• Primary DI: M430S70200111
• Version / Model: SYSTEME PSPIX WIN MAC
• Catalog Number: S_702_0011
• Company Name: SOPRO
• Labeler DUNS: 264205501
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 5
• Public Version Date: 2019-04-23
• Public Version Status: Update
• Public Device Record Key: a04adfb8-cd61-43fa-b146-7b1a6eee3e82

Device Description

"The PSPIX system is a laser X-ray device designed to digitize, display and erase intra oral x-ray images stored in imaging plates (IPs) - also known as phosphor plates."

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
MUH	System,X-Ray,Extraoral Source,Digital	Dental	872.1800	2

GMDN Terms

Code	Name	Definition	Implantable	Status
45257	Dental computed radiography digital imaging scanner	A device/device assembly designed to be used with an analogue dental x-ray system to capture radiographic images and then generate digital x-ray images from them as part of a two-step process (computed radiography) for image viewing, storage, or hard-copy printing. It consists of an image reader/scanner and may also include an exposure unit with imaging receptor (e.g., a cassette containing a plate), or additional supportive hardware (e.g., a printer). The image is acquired on a photostimulatable substance (e.g., a phosphor screen mounted on a cassette plate) and converted into an electrical analogue signal in a laser scanner; this device is dedicated to dental use.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	M430S70200111	HIBCC

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K151053	000