FEops

Primary DI
05430002070131
Brand
FEops
Company
FEops
Model
4.1.0
Catalog number
05430002070131
Device description
Feops HEARTguide Simulation Application
Published
2025-09-24
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
QQIInterventional Cardiovascular Implant Simulation Software Device

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QQIInterventional Cardiovascular Implant Simulation Software DeviceCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K214066000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K214066000FEops HEARTguideFeops NV2022-02-25QQI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05430002070131PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05430002070131054300020701315430002070131

GMDN Terms#

Term, Definition table
TermDefinition
Radiology DICOM image processing application softwareA software application intended to facilitate management, distribution, and/or viewing of radiological digital imaging and communications in medicine (DICOM) image data; it is not intended for pathological image interpretation (i.e., not intended to detect and localize suspected abnormalities). It may be intended to facilitate image management (e.g., viewing, communication, printing, recording/disc burning) and/or image quality manipulation and quantification (e.g., non-interpretive graphical overlays).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
400455685
Device count
1
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05430002070148FEops4.2.005430002070482026-05-21
05430002070124FEops3.3.0054300020701242025-09-25
05430002070087FEops3.1.0054300020700872024-04-26
05430002070094FEops3.1.0054300020700942024-04-26
05430002070056FEops3.0.0054300020700562023-06-30
05430002070063FEops3.0.12023-06-30
05430002070032FEops1.4.12021-11-30
05430002070070FEops1.4.22022-03-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05430002070148FEopsFEopsQQI2026-05-21
00860011603207PrecisionTAVIDasiSimulations LLCQQI2025-08-07
05430002070094FEopsFEopsQQI2024-04-26
05430002070056FEopsFEopsQQI2023-06-30
05430002070070FEopsFEopsQQI2022-03-29
05430002070032FEopsFEopsQQI2021-11-30