FDA.reportPublic FDA data

sterEOS®

Primary DI
03663999000030
Brand
sterEOS®
Company
EOS IMAGING
Model
Software 1.6
Device description
sterEOS workstation software
Published
2016-09-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
LLZSystem, Image Processing, Radiological

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LLZSystem, Image Processing, RadiologicalRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K141137000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K141137000STEREOS WORKSTATIONEos Imaging2014-09-15LLZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03663999000030PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03663999000030036639990000303663999000030

GMDN Terms#

Term, Definition table
TermDefinition
Basic x-ray clinical assessment support softwareA software program intended to display, analyse/process, and possibly acquire static two-dimensional (2-D) x-ray images of bones and/or the abdominothoracic region, acquired by a basic diagnostic x-ray system, to support a healthcare provider with clinical assessment (e.g., diagnosis, triage, image quality assessment) of a trauma or condition (typically orthopaedic, cardiac or pulmonary). It is not dedicated to treatment planning and does not incorporate adaptive/dynamic machine learning (ML) models.

Contacts#

Phone, Email table
PhoneEmail
8669335301contact@eos-imaging.com

Regulatory Flags#

DUNS number
762320968
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03663999000375spineEOS5.x2025-08-01
03663999000429VEA Align4.x2026-06-12
03663999000436AutoDensity1.32025-12-09
03663999000412VEA Align3.x2025-08-01
03663999000306VEA Portal1.02024-02-13
03663999000337VEA Align2.12024-07-05
03663999000290VEA Align1.02024-05-29
03663999000153sterEOS1.102024-02-14
03663999000191EOS Portal2.142023-07-10
03663999000047sterEOS®Workstation 1.82016-09-21
03663999000054sterEOS®Software 1.82016-09-21
03663999000023sterEOS®Workstation 1.62016-09-21
03663999000108EOSedge™2.12020-02-27
03663999000313spineEOS4.12024-07-02
03663999000160spineEOS1.22023-07-10
03663999000177hipEOS3.22023-07-10
03663999000405EOSedge3EOSEDGE30NA2025-05-14
03663999000139EOSedge chair22024-02-13
03663999000184spineEOS3.02024-02-15
03663999000061Radiolucent ChairC90001130402023-07-10

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Primary DI, Brand, Company table
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