Identity
- Trade Name
- RADIALIS PET CAMERA FDA UDI
- Generic Name
- PET system FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- 0140 FDA UDI
- Description
- 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. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850031455016 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 Camera by Radialis, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as PET system.
- Discovery — GE MEDICAL SYSTEMS, INC. · Class II
- Omni — Ge Medical Systems Israel , Ltd. · Class II
- Discovery — GE MEDICAL SYSTEMS, INC. · Class II
- Discovery — GE MEDICAL SYSTEMS, INC. · Class II
- Discovery — GE MEDICAL SYSTEMS, INC. · Class II
- SET-5002 — Shimadzu Corp. · Class II
- Discovery — GE MEDICAL SYSTEMS, INC. · Class II
- Discovery — GE MEDICAL SYSTEMS, INC. · Class II
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Radialis, Inc.
Sources (1)
- FDA UDI f7cad2ef-0491-4af5-9f6e-a3002734524c 35 fields · synced Jun 8, 2026