Duns Number:713565195
Device Description: The DR-ID 1811SE, DR-ID 1812SE and DR-ID 1814SE incorporate a CsI indirect panel. The indi The DR-ID 1811SE, DR-ID 1812SE and DR-ID 1814SE incorporate a CsI indirect panel. The indirect-conversion flat panel sensor is a device which acquires a general radiograph.
Catalog Number
-
Brand Name
D-EVOIII C35i
Version/Model Number
DR-ID 1811 SE E
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
MQB
Product Code Name
Solid state x-ray imager (flat panel/digital imager)
Public Device Record Key
31519c4c-fb61-4595-98f1-babdac4c68a8
Public Version Date
June 17, 2021
Public Version Number
1
DI Record Publish Date
June 09, 2021
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 |