FDA.reportPublic FDA data

ImagingRing m

Primary DI
19120075320112
Brand
ImagingRing m
Company
medPhoton GmbH
Model
2
Catalog number
P04-1
Device description
ImagingRing m, Version 2: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
2025-05-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
K234067000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K234067000ImagingRing m (Version 2.0); Loop-X (Version 2.0); Loop-X Mobile Imaging Robot (Version 2.0)Medphoton GmbH2025-03-28OWB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
19120075320112PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1912007532011219120075320112

GMDN Terms#

Term, Definition table
TermDefinition
Multi-modality diagnostic x-ray system, mobileA mobile assembly of diagnostic x-ray devices intended to acquire, display and process images from any part of the body (full-body) incorporating the techniques of more than one x-ray imaging modality, typically including real-time fluoroscopy, two-dimensional (2D) radiography, and computed tomography (CT); it is not a single-modality system. 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
Manufacturing date on label
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
19120075320129Loop-X2P04-22025-05-28
19120075320013ImagingRing1.12018-02-09
19120075320037ImagingRing1.22018-10-25
19120075320068ImagingRing m12021-03-22
19120075320075Loop-X1P04-22021-03-22

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Primary DI, Brand, Company table
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