Duns Number:689229516
Device Description: Green X (Model: PHT-75CHS), a digital radiographic imaging system, acquires and processes Green X (Model: PHT-75CHS), a digital radiographic imaging system, acquires and processes multi-FOV diagnostic images for dentists. Designed explicitly for dental radiography, Green X (Model: PHT-75CHS)is a complete digital X-ray system equipped with imaging viewers, an X-ray generator, and a dedicated SSXI detector.
Catalog Number
-
Brand Name
Green X
Version/Model Number
PHT-75CHS
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
K201627
Product Code
OAS
Product Code Name
X-Ray, Tomography, Computed, Dental
Public Device Record Key
e631d012-4130-4eb1-8995-1ed19847ef4d
Public Version Date
August 03, 2022
Public Version Number
1
DI Record Publish Date
July 26, 2022
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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 76 |