Duns Number:863358955
Device Description: Imagescan HD with 33" Straight arm is High Frequency Extra oral X-Ray source to be used fo Imagescan HD with 33" Straight arm is High Frequency Extra oral X-Ray source to be used for Intra oral X-Ray in DentalRadiography for diagnostic purpose
Catalog Number
-
Brand Name
Imagescan HD
Version/Model Number
303-001203-0
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"
-
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
K170967
Product Code
EHD
Product Code Name
Unit, X-Ray, Extraoral With Timer
Public Device Record Key
b7f8da19-2e86-4a11-be44-0037e37c37eb
Public Version Date
January 19, 2022
Public Version Number
2
DI Record Publish Date
August 10, 2020
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 | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 24 |