Nical Flat Panel

Basic Information

• Brand Name: Nical Flat Panel
• Primary DI: 08056600520051
• Version / Model: NFP Digital detector
• Catalog Number: NFPMD4335
• Company Name: NICAL SPA
• Labeler DUNS: 435743877
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-10-09
• Public Version: 1
• Public Version Date: 2023-10-17
• Public Version Status: New
• Public Device Record Key: 203dfdf4-6684-4969-b7a9-e61964f75dbb

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: Yes
• 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
MQB	Solid State X-Ray Imager (Flat Panel/Digital Imager)	Radiology	892.1680	2

GMDN Terms

Code	Name	Definition	Implantable	Status
17904	Computed radiography digital imaging scanner	A device/device assembly designed to be used with an analogue 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 is not dedicated to dental use. 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08056600520051	GS1

Premarket Submissions

Submission Number	Supplement Number
K053029	000