ImagingRing m P04-1

GUDID 19120075320068

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.

medPhoton GmbH

Full-body CT/general-purpose fluoroscopic x-ray system
Primary Device ID19120075320068
NIH Device Record Keyfd889ba5-27e0-4697-963a-fba7115aa248
Commercial Distribution StatusIn Commercial Distribution
Brand NameImagingRing m
Version Model Number1
Catalog NumberP04-1
Company DUNS300376801
Company NamemedPhoton GmbH
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS119120075320068 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OWBInterventional Fluoroscopic X-Ray System

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-03-30
Device Publish Date2021-03-22

Devices Manufactured by medPhoton GmbH

19120075320068 - ImagingRing m2021-03-30Mobile (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.
19120075320068 - ImagingRing m2021-03-30 Mobile (within an imaging facility) assembly of diagnostic x-ray computed tomography (CT) and fluoroscopic devices intended to a
19120075320075 - Loop-X2021-03-30 Loop-X Mobile Imaging Robot: Mobile (within an imaging facility) assembly of diagnostic x-ray computed tomography (CT) and fluor
19120075320013 - ImagingRing2019-04-23
19120075320037 - ImagingRing2019-04-23

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