FLUOBEAM 800

Basic Information

• Brand Name: FLUOBEAM 800
• Primary DI: B475FB800CLV190
• Version / Model: FB800-CL v1.9
• Company Name: FLUOPTICS
• Labeler DUNS: 260631677
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-06-25
• Public Version: 2
• Public Version Date: 2023-10-02
• Public Version Status: Update
• Public Device Record Key: 9367527f-3527-46cd-b16f-ba4075bf6e7d

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: 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
OWN	Confocal Optical Imaging	Gastroenterology, Urology	876.1500	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35580	Diagnostic-imaging multiformat camera	An electrically-powered camera-based imaging unit, typically using laser scanning techniques, that is designed to capture digital images created using diagnostic imaging systems, e.g., computed tomography (CT), magnetic resonance imaging (MRI), positron emission tomography (PET), gamma camera or ultrasound, and to reproduce them in variable image formats on x-ray or radiographic film. This device usually has adjustments that allow the operator to determine how many images will be recorded on one film sheet (multi-formatting). This can be typically anywhere from 1 to 128 images in multiples of two which can be recorded onto a single sheet of film.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B475FB800CLV190	HIBCC

Premarket Submissions

Submission Number	Supplement Number
K132475	000