sterEOS

GUDID 03663999000153

EOS IMAGING

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 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	03663999000153
NIH Device Record Key	dbeba98a-3ddb-47d4-ac0c-46ac8ab91025
Commercial Distribution Status	In Commercial Distribution
Brand Name	sterEOS
Version Model Number	1.10
Company DUNS	762320968
Company Name	EOS IMAGING
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	true
Serial Number	false
Manufacturing Date	false
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	03663999000153 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K172346

FDA Product Code

LLZ	System, Image Processing, Radiological

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	2024-02-22
Device Publish Date	2024-02-14

Devices Manufactured by EOS IMAGING

03663999000184 - spineEOS	2024-02-23
03663999000153 - sterEOS	2024-02-22
03663999000153 - sterEOS	2024-02-22
03663999000061 - Radiolucent Chair	2023-07-18
03663999000160 - spineEOS	2023-07-18
03663999000177 - hipEOS	2023-07-18
03663999000191 - EOS Portal	2023-07-18
03663999000108 - EOSedge™	2020-03-06
03663999000009 - EOS®	2020-02-28

Trademark Results [sterEOS]

Mark Image Registration \| Serial	Company Trademark Application Date
STEREOS 86632974 not registered Dead/Abandoned	Mass Fidelity Inc. 2015-05-18
STEREOS 79062307 3825206 Live/Registered	EOS IMAGING 2008-05-16
STEREOS 74673429 1999387 Dead/Cancelled	EOS GmbH Electro Optical Systems 1995-05-12