Duns Number:078671236
Device Description: This a motorized mobile diagnostic x-ray system. The Mobile Direct Radiographic system fac This a motorized mobile diagnostic x-ray system. The Mobile Direct Radiographic system facilitates x-ray examinations, in situations where it is not feasible to transport the patient to a ward with fixed equipment. The unit is precise, yet easy to maneuver due to smooth battery-powered motorization
Catalog Number
-
Brand Name
Del Medical
Version/Model Number
MDR
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
K173018
Product Code
IZL
Product Code Name
System, X-Ray, Mobile
Public Device Record Key
f00f0daa-4b42-4d6c-8532-6bb95fb955bd
Public Version Date
August 19, 2019
Public Version Number
1
DI Record Publish Date
August 09, 2019
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 | 19 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 15 |