FDR AQRO - The DR-XD 1000 (FDR AQRO) is a digital mobile - FUJIFILM CORPORATION

Duns Number:713565195

Device Description: The DR-XD 1000 (FDR AQRO) is a digital mobile X-ray system intended for use in general pur The DR-XD 1000 (FDR AQRO) is a digital mobile X-ray system intended for use in general purposeradiography for generating radiographic images of human anatomy, including adult, pediatric, andneonatal exams. The DR-XD 1000 is not intended for mammography applications.

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More Product Details

Catalog Number

-

Brand Name

FDR AQRO

Version/Model Number

DR-XD 1000

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)

-

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

IZL

Product Code Name

System, x-ray, mobile

Device Record Status

Public Device Record Key

056024e3-3abd-40d0-9c33-087a494f5a81

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

June 30, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"FUJIFILM CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 43
2 A medical device with a moderate to high risk that requires special controls. 324
3 A medical device with high risk that requires premarket approval 1