Duns Number:203884668
Device Description: The Radialis PET Camera (or Radialis PET Imager) is a high spatial resolution, small field The Radialis PET Camera (or Radialis PET Imager) is a high spatial resolution, small field-of-view PET imaging camera specifically developed for close-range, organ-targeted (i.e., limited field) imaging. The Radialis PET Camera is a partial-ring planar PET camera, equipped with lutetium-containing gamma-ray detectors, which collect gamma rays emitted by injected positron-emitting radiopharmaceuticals, and generates images corresponding to the relative concentrations of these radiopharmaceuticals in the body. The Radialis PET Camera is designed to collect gamma rays emitted by the injected radiopharmaceutical in a patient’s body part with high efficiency.
Catalog Number
0133
Brand Name
RADIALIS PET CAMERA
Version/Model Number
133
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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
K214062
Product Code
KPS
Product Code Name
System, Tomography, Computed, Emission
Public Device Record Key
e1c76788-c37c-4d70-9b20-5585b5325b0e
Public Version Date
June 01, 2022
Public Version Number
1
DI Record Publish Date
May 24, 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. | 1 |