BRIGHTONIX B960D-2

GUDID 08809873532005

PHAROS is a specialized high-sensitivity and high-resolution PET system designed for imaging specific organs, such as the brain, breast, arms and legs. Input voltage: 200-240V~ / Specification: 4 Detector modules

Brightonix Imaging Inc.

PET system
Primary Device ID08809873532005
NIH Device Record Keya0278370-f05e-4a80-ab24-c3d70561ab95
Commercial Distribution StatusIn Commercial Distribution
Brand NameBRIGHTONIX
Version Model NumberPHAROS
Catalog NumberB960D-2
Company DUNS696363885
Company NameBrightonix Imaging Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+8227668745
Emailinfo@brtnx.com
Phone+8227668745
Emailinfo@brtnx.com
Phone+8227668745
Emailinfo@brtnx.com
Phone+8227668745
Emailinfo@brtnx.com
Phone+8227668745
Emailinfo@brtnx.com
Phone+8227668745
Emailinfo@brtnx.com
Phone+8227668745
Emailinfo@brtnx.com
Phone+8227668745
Emailinfo@brtnx.com
Phone+8227668745
Emailinfo@brtnx.com

Device Identifiers

Device Issuing AgencyDevice ID
GS108809873532005 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KPSSystem, Tomography, Computed, Emission

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-10-01
Device Publish Date2025-09-23

On-Brand Devices [BRIGHTONIX]

08809873532050PHAROS is a specialized high-sensitivity and high-resolution PET system designed for imaging spe
08809873532043PHAROS is a specialized high-sensitivity and high-resolution PET system designed for imaging spe
08809873532036PHAROS is a specialized high-sensitivity and high-resolution PET system designed for imaging spe
08809873532029PHAROS is a specialized high-sensitivity and high-resolution PET system designed for imaging spe
08809873532012PHAROS is a specialized high-sensitivity and high-resolution PET system designed for imaging spe
08809873532005PHAROS is a specialized high-sensitivity and high-resolution PET system designed for imaging spe

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