Duns Number:117116896
Device Description: The uMI 550 PET/CT is a diagnostic imaging system that combines two existing imaging modal The uMI 550 PET/CT is a diagnostic imaging system that combines two existing imaging modalities - PET and CT. This system is intended to be operated by qualified healthcare professionals.
Catalog Number
-
Brand Name
uMI VM
Version/Model Number
uMI 550 VM
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
JAK
Product Code Name
System, X-Ray, Tomography, Computed
Public Device Record Key
0b87d2ea-5c71-4252-ad90-96a3f027db94
Public Version Date
November 29, 2021
Public Version Number
1
DI Record Publish Date
November 19, 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. | 9 |