I-MAX 3D

Basic Information

• Brand Name: I-MAX 3D
• Primary DI: 03760262651828
• Version / Model: I-MAX 3D PAN CEPH 110-120V
• Catalog Number: 9304301011
• Company Name: OWANDY RADIOLOGY
• Labeler DUNS: 265612235
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-12-16
• Public Version: 2
• Public Version Date: 2023-06-12
• Public Version Status: Update
• Public Device Record Key: 6703087c-9db8-4102-a6ad-5f273729f995

Device Description

I-MAX 3D CEPH version

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: 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
OAS	X-Ray, Tomography, Computed, Dental	Radiology	892.1750	2
MUH	System, X-Ray, Extraoral Source, Digital	Dental	872.1800	2

GMDN Terms

Code	Name	Definition	Implantable	Status
44245	Stationary panoramic/tomographic dental x-ray system, digital	A diagnostic digital dental x-ray system designed for permanent fixture in one location with an extraoral x-ray sensor and source intended to generate and control x-ray beams used in advanced dental imaging applications involving the teeth, jaw, oral cavity, sinus, and/or other maxillofacial structures. It uses digital techniques for image capture, manipulation and display and may include various image processing and analysis capabilities. This system is designed with the capability to produce two or more special purpose dental x-ray examinations: linear scanning, panoramic, cephalometric, linear tomography, spiral tomography, scanograms.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	03760262651828	GS1

Premarket Submissions

Submission Number	Supplement Number
K201382	000

Storage Conditions

• Type: Handling Environment Atmospheric Pressure
• Temperature Range: 70 – 106 KiloPascal
• Type: Handling Environment Humidity
• Temperature Range: 30 – 75 Percent (%) Relative Humidity
• Type: Handling Environment Temperature
• Temperature Range: 10 – 35 Degrees Celsius
• Type: Storage Environment Atmospheric Pressure
• Temperature Range: 63 – 106 KiloPascal
• Type: Storage Environment Humidity
• Temperature Range: 0 – 95 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: -20 – 70 Degrees Celsius