Identity
- Trade Name
- FLUOROspeed EUDAMEDFDA UDI
- Generic Name
- Stationary general-purpose fluoroscopic x-ray system, digital FDA UDI
- Device Name
- X-RAY R/F SYSTEM FLUOROspeed EUDAMED
- Model / Reference
- 566-23000-01 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 04540217061716 EUDAMEDFDA UDI
- Basic UDI-DI
- B-04540217061716 EUDAMED
- 510(k) Number
- K191877 FDA UDI
- FDA Product Code
- JAA FDA UDI
- EMDN Code
- Z11030702 DIGITAL REMOTE CONTROL TABLES EUDAMED
- GMDN Term
- Stationary general-purpose fluoroscopic x-ray system, digital FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1650 FDA UDI
- 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
Yes
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
FLUOROspeed by Shimadzu Corporation — Class IIb — FDA_510K, MDD — 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/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K191877 | Class IIb | Active |
| EUDAMED | European Union | CE/MDD | B-04540217061716 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Shimadzu Corporation
- EUDAMED SRN
- JP-MF-000025145
- Authorised Representative
- Shimadzu Europa GmbH DE-AR-000013563
Sources (3)
- EUDAMED 64b5b805-bc0c-4df7-a26f-3a3e054f65de 61 fields · synced Jul 19, 2026
- FDA UDI 8652fb0c-b3a6-49f0-aa1d-4008d4fb0b01 33 fields · synced May 30, 2026
- FDA 510(k) K191877 1 fields · synced May 18, 2026