Identity
- Trade Name
- CLISIS SYSTEMS FDA UDI
- Generic Name
- Portable general-purpose fluoroscopic x-ray system, analogue FDA UDI
- Device Name
- The wall bucky stand is used to perform exposures on the potter-bucky. FDA UDI
- Model / Reference
- WS FDA UDI
- Description
- The wall bucky stand is used to perform exposures on the potter-bucky. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08054890480086 FDA UDI
- 510(k) Number
- K213081 FDA UDI
- FDA Product Code
- IZL FDA UDI
- GMDN Term
- Portable general-purpose fluoroscopic x-ray system, analogue FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1720 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: Portable general-purpose fluoroscopic x-ray system, analogue
Clisis Systems by General Medical Merate Spa — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Portable general-purpose fluoroscopic x-ray system, analogue.
- ARCADIS Varic — Siemens Healthcare · Class II
- ARCADIS Orbic — Siemens Healthcare · Class II
- Cios Select — Siemens Shanghai Medical Equipment Ltd. · Class II
- Cios Connect — Siemens Healthcare · Class II
- CIOS SELECT — Siemens Shanghai Medical Equipment Ltd. · Class II
- ARCADIS Avantic — Siemens Healthcare · Class II
- SIREMOBIL Compact L — Siemens Healthcare · 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 fa2a84eb-dd55-4151-853c-3044bee022b1 34 fields · synced May 30, 2026