Identity
- Trade Name
- SICAT Suite FDA UDI
- Generic Name
- Diagnostic x-ray digital imaging system workstation FDA UDI
- Model / Reference
- 6455633 FDA UDI
Identifiers
- Catalog Number
- 6455633 FDA UDI
- Primary DI / UDI-DI
- D77664556330 FDA UDI
- FDA Product Code
- LLZ FDA UDI
- GMDN Term
- Diagnostic x-ray digital imaging system workstation FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.2050 FDA UDI
- Commercial Distribution
- Not 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
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
SICAT Suite by SiCAT GmbH & Co. KG — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K152661 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
- SiCAT GmbH & Co. KG
Sources (1)
- FDA UDI 985a227d-89ee-492f-baf7-68125e755527 36 fields · synced May 30, 2026