FDA.reportPublic FDA data

ImagingRing m

Primary DI
19120075320068
Brand
ImagingRing m
Company
medPhoton GmbH
Model
1
Device description
Mobile (within an imaging facility) assembly of diagnostic x-ray computed tomography (CT) and fluoroscopic devices intended to acquire, display and process both: 1) two- and/or three-dimensional (3-D) cross-sectional (tomographic) images; and 2) real-time fluoroscopic images, from any part of the body for a variety of applications.
Published
2021-03-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Product Codes#

Code, Name table
CodeName
OWBInterventional Fluoroscopic X-Ray System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OWBInterventional Fluoroscopic X-Ray SystemRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K203281000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K203281000Mobile ImagingRing System, IRm, Loop-X Mobile Imaging Robot, Loop-XMedphoton GmbH2020-12-22OWB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
19120075320068PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1912007532006819120075320068

GMDN Terms#

Term, Definition table
TermDefinition
Full-body CT/general-purpose fluoroscopic x-ray systemA mobile (within an imaging facility) assembly of diagnostic x-ray computed tomography (CT) and fluoroscopic devices intended to acquire, display and process both: 1) two- and/or three-dimensional (3-D) cross-sectional (tomographic) images; and 2) real-time fluoroscopic images, from any part of the body for a variety of applications. It typically consists of a gantry with x-ray tubes and opposing detectors that rotate rapidly, console, monitor and patient bed.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
300376801
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
19120075320020ImagingRing r12026-04-21
19120075320105Mobile Monitor Cart System MMCS1A00932025-06-10
19120075320136Remote Control Charging Cart RCCS1A010522025-06-10
19120075320112ImagingRing m2P04-12025-05-28
19120075320129Loop-X2P04-22025-05-28
19120075320013ImagingRing1.12018-02-09
19120075320037ImagingRing1.22018-10-25
19120075320075Loop-X1P04-22021-03-22

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