Duns Number:690575113
Device Description: This device is used to acquire transaxial images of any desired region of the body, provid This device is used to acquire transaxial images of any desired region of the body, providing a wide range of diagnostic capabilities.
Catalog Number
-
Brand Name
PET-CT SCANNER
Version/Model Number
PCD-1000A
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
K203314
Product Code
JAK
Product Code Name
System, X-Ray, Tomography, Computed
Public Device Record Key
a4c6fff4-8314-4016-90d1-105b489a7cc3
Public Version Date
December 22, 2021
Public Version Number
1
DI Record Publish Date
December 14, 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 | 2 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 200 |