FDA.reportPublic FDA data

Soteria Eview

Primary DI
00853901007049
Brand
Soteria Eview
Company
OMEGA MEDICAL IMAGING, LLC
Model
GI-100
Catalog number
NA
Device description
Interventional Imaging System consisting of a C-Arm, Patient Table, High Voltage Generator, X-Ray Tube, Flat Panel Detector and Image Processor.
Published
2025-10-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
JAASystem, X-Ray, Fluoroscopic, Image-Intensified

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JAASystem, X-Ray, Fluoroscopic, Image-IntensifiedRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K242488000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K242488000Soteria E-ViewOmega Medical Imaging, LLC2025-01-06JAA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00853901007049PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00853901007049008539010070498539010070490853901007049

GMDN Terms#

Term, Definition table
TermDefinition
Stationary angiographic x-ray system, digitalA stationary diagnostic fluoroscopic x-ray system specifically designed to optimize the capability of users to visually and quantitatively evaluate the anatomy and function of blood vessels of the heart, brain and other organs, as well as the lymphatic system. It uses digital techniques for real-time image capture, display and manipulation and typically includes spot-film capabilities in addition to the fluoroscopic features. It is commonly used in conjunction with an injected x-ray contrast medium during either imaging or x-ray guided surgical or interventional procedures. Images can be viewed in both real-time and delayed formats.

Regulatory Flags#

DUNS number
622534493
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00853901007018Omega Medical Imaging, LLCCS-series-FP2019-08-19
00853901007032Nyquist.IQIPS-1002022-03-17
00853901007025Omega Medical Imaging, LLCSoteria.AI2022-01-18
00853901007001Omega Medical ImagingCS502017-05-04

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Primary DI, Brand, Company table
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00195451000393Shockwave IVL System with the Shockwave L6 Peripheral IVL CatheterShockwave Medical, Inc.JAA2022-10-24
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