Identity
- Trade Name
- RADIALIS PET IMAGER FDA UDI
- Generic Name
- PET system FDA UDI
- Device Name
- The Radialis PET Imager (or Radialis PET Camera) 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. FDA UDI
- Model / Reference
- 133 FDA UDI
- Description
- The Radialis PET Imager (or Radialis PET Camera) 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. FDA UDI
Identifiers
- Catalog Number
- 0133 FDA UDI
- Primary DI / UDI-DI
- 00850031455337 FDA UDI
- 510(k) Number
- K214062 FDA UDI
- FDA Product Code
- KPS FDA UDI
- GMDN Term
- PET system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1200 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Category: PET system
Radialis Pet Imager by Radialis, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K214062 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Radialis, Inc.
Sources (1)
- FDA UDI 937fc545-885f-4575-9634-319e43484f9f 36 fields · synced May 30, 2026