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Sicat Function V2.0.40
EUDAMEDFDA UDIFDA 510(k)Class IIa (EU MDR)
Ref 10260501510(k) K133320
Identity
- Trade Name
- SICAT FUNCTION V2.0.40 EUDAMEDSICAT FUNCTION FDA UDI
- Generic Name
- Radiological PACS software FDA UDI
- Device Name
- SICAT FUNCTION EUDAMED
- Model / Reference
- 10260501 EUDAMEDV2.0.40 FDA UDI
Identifiers
- Primary DI / UDI-DI
- D776FUNCTIONV20400 EUDAMEDFDA UDI
- Basic UDI-DI
- ++D776FUNCTIONGM EUDAMED
- 510(k) Number
- K133320 FDA UDI
- FDA Product Code
- LLZ FDA UDI
- EMDN Code
- Z110603 PICTURE ARCHIVING AND COMMUNICATION SYSTEMS EUDAMED
- GMDN Term
- Radiological PACS software FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 892.2050 FDA UDI
- Special Device Type
- Software EUDAMED
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Sicat Function V2.0.40 by SICAT GmbH & Co. KG — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K133320 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | ++D776FUNCTIONGM | Class IIa | Active |
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Manufacturer
- Manufacturer
- SICAT GmbH & Co. KG
- EUDAMED SRN
- DE-MF-000005604
Sources (3)
- EUDAMED 0b1e1dae-9e06-43f0-8686-37c5a136fc21 85 fields · synced Jun 18, 2026
- FDA UDI 35473956-1a1d-465a-a663-2eb9cf5e97e7 33 fields · synced May 30, 2026
- FDA 510(k) K133320 1 fields · synced May 18, 2026