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.
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
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"
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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
IZL
Product Code Name
System, x-ray, mobile
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
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| 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 |