Duns Number:421363780
Device Description: The Digital Intra-Oral X-Ray Imaging System (Pluto0001X/Pluto0002X) is used in conjunction The Digital Intra-Oral X-Ray Imaging System (Pluto0001X/Pluto0002X) is used in conjunction with dental Radiography in medicalunits. The product is used for dental X-ray examination and the diagnosis of structural diseases. The product is expected to beused in hospitals and clinics, operated and used by trained professionals under the guidance of doctors. This device is notintended for mammography and conventional photography applications. This device is suitable for providing dental radiographyimaging for both adult and pediatric.
Catalog Number
/
Brand Name
Digital Intraoral X-ray Imaging System
Version/Model Number
Pluto0001X
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
-
Product Code
MUH
Product Code Name
System, X-Ray, Extraoral Source, Digital
Public Device Record Key
17afa1e1-5a32-4d05-884f-f1ba46ec8571
Public Version Date
October 04, 2021
Public Version Number
3
DI Record Publish Date
July 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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 32 |