Ashvins variant HEYEX 2 / HEYEX PACS

Basic Information

• Brand Name: Ashvins variant HEYEX 2 / HEYEX PACS
• Primary DI: 04260648620015
• Version / Model: 2.5
• Company Name: MedicalCommunications GmbH
• Labeler DUNS: 314721366
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-03-27
• Public Version: 2
• Public Version Date: 2022-06-10
• Public Version Status: Update
• Public Device Record Key: 4f784b7e-bf70-4ce0-a3d2-e3edfa20bf34

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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: 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
LLZ	System, Image Processing, Radiological	Radiology	892.2050	2
NFJ	System, Image Management, Ophthalmic	Radiology	892.2050	2

GMDN Terms

Code	Name	Definition	Implantable	Status
63764	Ophthalmology PACS software	A software program intended to be used primarily as a picture archiving and communication system (PACS) to allow storage, retrieval, and management of digital images of the eye. It may be web-based or installed on a central server for access by a healthcare professional; some types include features for image analysis.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04260648620015	GS1

Premarket Submissions

Submission Number	Supplement Number
K200132	000