ASPIRE Bellus II

GUDID 04547410345438

ASPIRE Bellus II is medical imaging software that is intended to provide trained medical imaging professionals, including Physicians and Radiologists, with tools to aid them in reading, interpreting, reporting. This product accepts DICOM compliant medical images acquired from a variety of imaging devices including, MG, CT, PT, MR, CR, DX, and US, etc. This product also provides general 2D/3D viewing and general image processing, measurements, annotations, reporting, printing, storing, and general image administration tools, etc.

FUJIFILM CORPORATION

Radiology picture archiving and communication system workstation
Primary Device ID04547410345438
NIH Device Record Keyedd133f5-8bd7-46f1-9e1b-6393996342c3
Commercial Distribution StatusIn Commercial Distribution
Brand NameASPIRE Bellus II
Version Model NumberMIS-1000
Company DUNS713565195
Company NameFUJIFILM CORPORATION
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 Batchtrue
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+018002728465
Emailxxx@xxx.xxx

Device Identifiers

Device Issuing AgencyDevice ID
GS104547410345438 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LLZSystem, image processing, radiological

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2019-11-18
Device Publish Date2018-01-31

Devices Manufactured by FUJIFILM CORPORATION

04547410541199 - FUJIFILM2024-02-26 This software is a computer-assisted reading tool designed to aid endoscopists in detecting colonic mucosal lesions (such as pol
04547410509984 - FUJIFILM2024-01-04 This product is a medical ultrasonic probe. It is intended for the observation and diagnosis of the gastrointestinal tract and s
04547410509991 - FUJIFILM2024-01-04 This product is a medical ultrasonic probe. It is intended for the observation and diagnosis of the gastrointestinal tract and s
04547410520903 - FUJIFILM2023-12-25 This product is intended to be used in combination with the FUJIFILM Leak Tester LT-100 to perform leak testing for a FUJIFILM e
14547410520917 - FUJIFILM2023-12-25 This product is intended to check whether the FUJIFILM Leak Tester LT-100 can properly test the airtightness of a FUJIFILM endos
04547410377248 - FUJIFILM2023-12-11 FUJIFILM Endoscope Model EG-740N is intended for the visualization of the upper digestive tract, specifically for the observati
04547410384536 - FUJIFILM2023-12-11 EI-580BT is a medical electronic endoscope intended to provide endoscopic images for observation, diagnosis, photographing and e
14547410397649 - FUJIFILM2023-12-11 This device is intended for the visualization of the lower digestive tract, specifically for the observation, diagnosis, and end

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.