Identity
- Trade Name
- CLISIS SYSTEMS FDA UDI
- Generic Name
- X-ray system tube support, ceiling mounted FDA UDI
- Device Name
- The ceiling suspension is a radiographic X-ray tube suspension device that allows direct digital radiological diagnostic, pulmonary, skeletal and emergency. FDA UDI
- Model / Reference
- KALOS FDA UDI
- Description
- The ceiling suspension is a radiographic X-ray tube suspension device that allows direct digital radiological diagnostic, pulmonary, skeletal and emergency. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08054890480093 FDA UDI
- 510(k) Number
- K213081 FDA UDI
- FDA Product Code
- IYB FDA UDI
- GMDN Term
- X-ray system tube support, ceiling mounted FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 892.1770 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: X-ray system tube support, ceiling mounted
Clisis Systems by General Medical Merate Spa — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as X-ray system tube support, ceiling mounted.
- CH-200 — Shimadzu Corp. · Class I
- CEILING-SUSPENDED TUBE SUPPORT — Canon Medical Systems Corporation · Class I
- CH-200 — Shimadzu Corp. · Class I
- Del Medical/Universal — DEL MEDICAL, INC. · Class I
- Del Medical/Universal — DEL MEDICAL, INC. · Class I
- halo — CORE LABS, LLC. · Class I
- CH-200M — Shimadzu Corp. · Class I
- Del Medical/Universal — DEL MEDICAL, INC. · Class I
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 I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- General Medical Merate Spa
Sources (1)
- FDA UDI 1a6375d4-6bc6-41a4-8a78-fdad437a46b7 34 fields · synced Jun 1, 2026