AccessGUDID - DEVICE: BRIGHTONIX (08809873532012)

GUDID

Device Identifier (DI) Information

Brand Name: BRIGHTONIX
Version or Model: PHAROS
Commercial Distribution Status: In Commercial Distribution
Catalog Number: B720D-2
Company Name: Brightonix Imaging Inc.

Primary DI Number: 08809873532012
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 696363885 *Terms of Use

Device Description: 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: 3 Detector modules

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
40644	PET system	An assembly of devices comprising a diagnostic, positron emission tomography (PET) imaging system used to detect, record, quantify and analyse 511 kilo-electronvolt (keV) photon emission patterns resulting from annihilation reactions produced during the decay of positron emitting radiopharmaceuticals. It produces three-dimensional (3-D) tomographic digital cross-sectional physiological images representing distribution patterns of positron emitting radiopharmaceuticals ingested by, or injected into the patient. It typically uses lead collimators and specialized software for image reconstruction allowing mapping of metabolic patterns and rates associated with targeted physiological processes.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KPS	System, Tomography, Computed, Emission

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K250170	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 6f001ed6-ae46-4e7b-a8f4-2534b0cb3607
Public Version Date: October 01, 2025
Public Version Number: 1
DI Record Publish Date: September 23, 2025