Loop-X - Loop-X Mobile Imaging Robot:Mobile (within an - medPhoton GmbH

Duns Number:300376801

Device Description: Loop-X Mobile Imaging Robot:Mobile (within an imaging facility) assembly of diagnostic x-r Loop-X Mobile Imaging Robot: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.

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More Product Details

Catalog Number

P04-2

Brand Name

Loop-X

Version/Model Number

1

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Unsafe

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K203281

Product Code Details

Product Code

OWB

Product Code Name

Interventional Fluoroscopic X-Ray System

Device Record Status

Public Device Record Key

930c9e61-bf77-45d0-9cee-7ca53070c7cb

Public Version Date

February 21, 2022

Public Version Number

2

DI Record Publish Date

March 22, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MEDPHOTON GMBH" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 4