Fraxion - "The FRAXION™ Stereotactic Frame is for target - Medical Intelligence Medizintechnik GmbH

Duns Number:314546664

Device Description: "The FRAXION™ Stereotactic Frame is for target localization in stereotactic radiation ther "The FRAXION™ Stereotactic Frame is for target localization in stereotactic radiation therapy and radiosurgery. The purpose of the stereotactic frame is to impose fiducials on images of the patient acquired during CT scanning. The fiducials are used for determining target coordinates and for slice alignment by treatment planningsoftware."

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More Product Details

Catalog Number

P10106-103

Brand Name

Fraxion

Version/Model Number

P10106-103

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

K112210

Product Code Details

Product Code

IYE

Product Code Name

Accelerator, Linear, Medical

Device Record Status

Public Device Record Key

1d0ecdc9-70bf-4927-9bc9-c9c4f6a5e9b3

Public Version Date

October 13, 2021

Public Version Number

5

DI Record Publish Date

August 23, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MEDICAL INTELLIGENCE MEDIZINTECHNIK GMBH" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 175