FDA.reportPublic FDA data

FLUOBEAM LX Red

Primary DI
B475FBLXR0
Brand
FLUOBEAM LX Red
Company
FLUOPTICS
Model
FBLXR
Device description
Fluorescence imaging system
Published
2024-05-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
QDGParathyroid Autofluorescence Imaging Device

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QDGParathyroid Autofluorescence Imaging DeviceGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K233564000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K233564000FLUOBEAM® LX Imaging System (FB-LX); FLUOBEAM® LX Red Imaging System (FB-LXR)Fluoptics Sas (A Getinge Group Company)2023-12-15QDG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B475FBLXR0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Intraoperative parathyroid detection system control unitAn electrically-powered component of an intraoperative parathyroid detection system designed to aid surgeons in recognizing parathyroid tissue during open surgical thyroidectomies and parathyroidectomies using near-infrared (NIR) light and auto-fluorescence. It consists of a console with display and controls. The NIR light is emitted, and the florescence measured, using a single-use invasive probe (not included).

Sterilization Methods#

Method table
Method

Regulatory Flags#

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B475FMSA0FLUOPODFMSA2023-09-29
B475FBLM0FLUOBEAM LMFBLM2021-02-18
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
B475FBLX0FLUOBEAM LXFLUOPTICSQDG2019-09-05