Identity
- Trade Name
- CLISIS SYSTEMS FDA UDI
- Generic Name
- Fluoroscopy/angiography table, powered FDA UDI
- Device Name
- It is an R&F remote controlled table, that can be used as a traditional R&F remote tilting table or it is possible to perform examination with detector directly in contact with the patient by using in combination the optional: Overhead Tube Suspension, Wall Stand and 2nd Wi-Fi detector. FDA UDI
- Model / Reference
- CLISIS EXEL DRF FDA UDI
- Description
- It is an R&F remote controlled table, that can be used as a traditional R&F remote tilting table or it is possible to perform examination with detector directly in contact with the patient by using in combination the optional: Overhead Tube Suspension, Wall Stand and 2nd Wi-Fi detector. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08054890480062 FDA UDI
- 510(k) Number
- K213081 FDA UDI
- FDA Product Code
- KXJ FDA UDI
- GMDN Term
- Fluoroscopy/angiography table, powered FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1980 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: Fluoroscopy/angiography table, powered
Clisis Systems by General Medical Merate Spa — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
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- 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 deffbe5a-1ed3-49f0-9676-45a5618d2faf 34 fields · synced May 30, 2026