Identity
- Trade Name
- CLISIS SYSTEMS FDA UDI
- Generic Name
- Stationary general-purpose fluoroscopic x-ray system, digital FDA UDI
- Device Name
- It's a system for acquiring digital images in fluoroscopy and radiography modes from a solid state large-sized detector, specifically designed to be integrated in radiology diagnostic rooms and emergency rooms. Opera D4000RF allows radiological diagnostic examinations to be performed in real time on the skeleton, the gastro-intestinal tract, the vascular system and urogenital system. FDA UDI
- Model / Reference
- OPERA D4000RF FDA UDI
- Description
- It's a system for acquiring digital images in fluoroscopy and radiography modes from a solid state large-sized detector, specifically designed to be integrated in radiology diagnostic rooms and emergency rooms. Opera D4000RF allows radiological diagnostic examinations to be performed in real time on the skeleton, the gastro-intestinal tract, the vascular system and urogenital system. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08054890480079 FDA UDI
- 510(k) Number
- K213081 FDA UDI
- FDA Product Code
- JAA FDA UDI
- GMDN Term
- Stationary general-purpose fluoroscopic x-ray system, digital FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1650 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
Category: Stationary general-purpose fluoroscopic x-ray system, digital
Clisis Systems by General Medical Merate Spa — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Stationary general-purpose fluoroscopic x-ray system, digital.
- CANON INC. — CANON INC. · Class II
- FLUOROspeed — Shimadzu Corp. · Class II
- NAUTILUS — TECHNIX SPA · Class II
- SONIALVISION G4 — Shimadzu Corp. · Class II
- Duet DRF — THALES AVS FRANCE SAS · Class II
- STEPHANIX — Stephanix · Class II
- STEPHANIX — Stephanix · Class II
- AMNOTEC — AMNOTEC International Medical GmbH · Class II
Cleared under the same submission
K213081 also covers:
- CLISIS SYSTEMS — GENERAL MEDICAL MERATE SPA
- CLISIS SYSTEMS — GENERAL MEDICAL MERATE SPA
- CLISIS SYSTEMS — GENERAL MEDICAL MERATE SPA
- CLISIS SYSTEMS — GENERAL MEDICAL MERATE SPA
- Discovery RF180 — GENERAL MEDICAL MERATE SPA
- Discovery RF180 — GENERAL MEDICAL MERATE SPA
- Discovery RF180 — GENERAL MEDICAL MERATE SPA
- Discovery RF180 — GENERAL MEDICAL MERATE SPA
- THALES — GENERAL MEDICAL MERATE SPA
- THALES — GENERAL MEDICAL MERATE SPA
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 |
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Manufacturer
- Manufacturer
- General Medical Merate Spa
Sources (1)
- FDA UDI f2fa82e9-f9fe-4aa0-a2da-57b9e38719e0 34 fields · synced Jun 8, 2026