XM15 - Rotating anode X-ray tube for radiography systems - I.A.E. INDUSTRIA APPLICAZIONI ELETTRONICHE SPA

Duns Number:430263475

Device Description: Rotating anode X-ray tube for radiography systems

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More Product Details

Catalog Number

-

Brand Name

XM15

Version/Model Number

0.1/0.3

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

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

-

Product Code Details

Product Code

ITY

Product Code Name

Assembly, Tube Housing, X-Ray, Diagnostic

Device Record Status

Public Device Record Key

0ca751b3-39e2-45f5-a9cd-00e186f5473e

Public Version Date

September 02, 2020

Public Version Number

1

DI Record Publish Date

August 25, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"I.A.E. INDUSTRIA APPLICAZIONI ELETTRONICHE SPA" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 148