ScanX 12 SE

Basic Information

• Brand Name: ScanX 12 SE
• Primary DI: D678F38050
• Version / Model: F3805
• Company Name: AIR TECHNIQUES, INC.
• Labeler DUNS: 043835081
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-23
• Public Version: 4
• Public Version Date: 2018-08-23
• Public Version Status: Update
• Public Device Record Key: ef10acab-3d2e-4499-83e5-e7eb983d859e

Device Description

ScanX 12 SE is a device that scans photostimulable phosphor plates that have been exposed in the place of x-ray film and allows those images to be displayed on a CRT and stored for later recovery in a computer memory. It is used as a podiatry unit.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: Yes
• 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
MQB	Solid State X-Ray Imager (Flat Panel/Digital Imager)	Radiology	892.1680	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35928	Radiography digital imaging scanner	A laser or light-based optical unit designed to convert medical images originally captured on x-ray film or phosphor storage plate (PSP) into a digital format. Examples of this device include devices employing video frame grabbers, and scanners which use lasers or charge-coupled devices. Depending on the design, the digitized images can then be digitally transferred from location to location, archived, or used with other digital image processing, analysis or recording systems.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	D678F38050	HIBCC
Package	D678F38051	HIBCC	box	1	In Commercial Distribution
Package	D678F38001	HIBCC	box	1	In Commercial Distribution

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K031198	000

Device Sizes

Type	Value	Unit	Text
Depth	14	Inch
Width	14	Inch
Height	28	Inch

Storage Conditions

• Type: Storage Environment Humidity
• Temperature Range: 5 – 95 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: -29 – 54 Degrees Celsius