FLUOBEAM LM

Primary DI
B475FBLM0
Brand
FLUOBEAM LM
Company
FLUOPTICS
Model
FBLM
Device description
Fluorescence imaging system
Published
2021-02-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
QGDImplanted Mechanical/Hydraulic Urinary Continence Device Surgical Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QGDImplanted Mechanical/Hydraulic Urinary Continence Device Surgical AccessoriesGastroenterology, Urology1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K190891000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K190891000Fluobeam LXFluoptics2019-07-31QDG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B475FBLM0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Stationary general-purpose fluoroscopic x-ray system, digitalA stationary general-purpose diagnostic fluoroscopic x-ray system that uses real-time digital techniques for image capture, display and manipulation and is specifically designed to be used in a variety of general-purpose applications requiring real-time fluoroscopic imaging. It includes spot-film capabilities in addition to the fluoroscopic features and is intended to optimize the capability of users to visually and quantitatively evaluate the anatomy and physiological function of various targeted body areas in real-time. It is frequently used in conjunction with an ingested or injected x-ray contrast medium. Images can be viewed in both real-time and delayed format.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
260631677
Device count
1
Combination product
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B475FMSA0FLUOPODFMSA2023-09-29
B475FBLXR0FLUOBEAM LX RedFBLXR2024-05-06
B475LXHO0FLUOCLIPLXHO2021-02-18
B475FBLX0FLUOBEAM LXFBLX2019-09-05
B475FB800CLV180FLUOBEAM 800FB800-CL v1.82017-04-27
B475FB800CLV190FLUOBEAM 800FB800-CL v1.92018-06-25
B475FC800CLV180FLUOCASE 800FC800-CL v1.82017-04-27
B475FC800CLV190FLUOCASE 800FC800-CL v1.92018-06-25
B475FKCL0FLUOCARTFK-CL2022-01-31
B475PVUEC0A1V100PHOTONVUEPVUEC0A1 V1.02017-04-27
B475PVUEC0A2V100PHOTONVUEPVUEC0A2 V1.02017-04-27
B475PVUECCB100PHOTONVUE CONTROL BOXPVUECCB-1.02018-01-19
B475PVUECOH100PHOTONVUE OPTICAL HEADPVUECOH-1.02018-01-19
B475PVUETSC101Photonvue boxPVUE-TSC-1.02018-01-19
B475FXCLV111FLUOBEAM SYSTEM STORED INTO FLUOBOXFX-CL v1.12017-04-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00878953000558Insertion PackageBOSTON SCIENTIFIC CORPORATIONQGD2014-09-24
00878953000664Deactivation PackageBOSTON SCIENTIFIC CORPORATIONQGD2014-09-24
00878953000831Quick Connect Assembly ToolBOSTON SCIENTIFIC CORPORATIONQGD2014-09-24