Identity
- Trade Name
- SET-5002 FDA UDI
- Generic Name
- PET system FDA UDI
- Model / Reference
- 567-11700-12 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04540217071630 FDA UDI
- 510(k) Number
- K240827 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
No
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
Category: PET system
Set-5002 by Shimadzu Corp. — 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
- RADIALIS PET IMAGER — Radialis, Inc. · Class II
- Discovery — GE MEDICAL SYSTEMS, INC. · Class II
- RADIALIS PET CAMERA — Radialis, Inc. · Class II
- Discovery — GE MEDICAL SYSTEMS, INC. · Class II
- Discovery — GE MEDICAL SYSTEMS, INC. · Class II
Cleared under the same submission
K240827 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
- Shimadzu Corp.
Sources (1)
- FDA UDI 0a1f7e47-643b-47c5-870c-82a5d7959dfb 33 fields · synced Jun 1, 2026