coDiagnostiX

Basic Information

• Brand Name: coDiagnostiX
• Primary DI: D835CDX1
• Version / Model: 9
• Company Name: Dental Wings GmbH
• Labeler DUNS: 342721295
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-17
• Public Version: 7
• Public Version Date: 2021-08-31
• Public Version Status: Update
• Public Device Record Key: 68940839-990a-46e5-a579-b51ab3683d2a
• Distribution End Date: 2021-08-31

Device Description

Dental implant planning software

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: No
• Has Lot/Batch Number: Yes
• 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
LLZ	System, Image Processing, Radiological	Radiology	892.2050	2

GMDN Terms

Code	Name	Definition	Implantable	Status
40935	Diagnostic x-ray digital imaging system workstation	A freestanding component of an x-ray-based diagnostic digital imaging assembly [e.g., a digital x-ray system, x-ray computed tomography (CT) system, or fluoroscopy system] designed to process patient radiological images; it may additionally be intended to be integrated as part of a radiology picture archiving and communication system (PACS). It consists of dedicated hardware (e.g., computer processing unit, monitor) with integrated software typically to assist image analysis (e.g., viewing, manipulation, interpretation); it does not include controls for direct operation of the imaging system.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	D835CDX202	HIBCC		40	Not in Commercial Distribution	2021-08-31
Primary	D835CDX1	HIBCC
Package	D835CDX201	HIBCC		20	Not in Commercial Distribution	2021-08-31
Package	D835CDX200	HIBCC		1	Not in Commercial Distribution	2021-08-31

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K130724	000

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Controlled moisture (no condensation)
• Type: Storage Environment Atmospheric Pressure
• Temperature Range: 12 – 106 KiloPascal
• Type: Storage Environment Humidity
• Temperature Range: 15 – 85 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: -29 – 60 Degrees Celsius