FDA.reportPublic FDA data

PHOTONVUE CONTROL BOX

Primary DI
B475PVUECCB100
Brand
PHOTONVUE CONTROL BOX
Company
FLUOPTICS
Model
PVUECCB-1.0
Device description
Control box of PhotonVue system
Published
2018-01-19
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
OWNConfocal Optical Imaging

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OWNConfocal Optical ImagingGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K132475000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K132475000FLUOBEAM 800 CLINIC LASER IMAGING DEVICE AND FLUOCASE 800 CONTROL SYSTEMFluoptics2014-05-07OWN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B475PVUECCB100PrimaryHIBCC0

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
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
B475PVUECOH100PHOTONVUE OPTICAL HEADPVUECOH-1.02018-01-19
B475PVUETSC101Photonvue boxPVUE-TSC-1.02018-01-19
B475FXCLV111FLUOBEAM SYSTEM STORED INTO FLUOBOXFX-CL v1.12017-04-27

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Primary DI, Brand, Company table
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