FEops 05430002070087

GUDID 05430002070087

FEops HEARTguide ALPACA

FEops

Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software

Primary Device ID	05430002070087
NIH Device Record Key	7b3ce961-4b65-4e90-a1e2-84149245156e
Commercial Distribution Status	In Commercial Distribution
Brand Name	FEops
Version Model Number	3.1.0
Catalog Number	05430002070087
Company DUNS	400455685
Company Name	FEops
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	false
Serial Number	false
Manufacturing Date	true
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Identifiers

Device Issuing Agency	Device ID
GS1	05430002070087 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K223855

FDA Product Code

QIH	Automated Radiological Image Processing Software

Sterilization

Steralize Prior To Use	false
Device Is Sterile	false

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2024-05-06
Device Publish Date	2024-04-26

On-Brand Devices [FEops]

05430002070032	FEops HEARTguide™ is indicated for patient-specific simulation of transcatheter left atrial ap
05430002070070	FEops HEARTguide™ is indicated for patient-specific simulation of transcatheter left atrial ap
05430002070063	FEops HEARTguide ALPACA 3.0.1
05430002070056	FEops HEARTguide Simulation Application
05430002070094	Feops HEARTguide Simulation Application
05430002070087	FEops HEARTguide ALPACA

Trademark Results [FEops]

Mark Image Registration \| Serial	Company Trademark Application Date
FEOPS 87798981 5615016 Live/Registered	FEops naamloze vennootschap 2018-02-15