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hyperion X5
EUDAMEDFDA 510(k)FDA UDIClass IIb (EU MDR)
Ref 70BA0000, 70B1A000Model Panoramic, cephalometric and tomographic X-ray equipment510(k) K161900Ref 70BR0000, 70B6R000510(k) K200688
by CEFLA s.c.
Identity
- Trade Name
- hyperion X5 EUDAMEDmyray FDA UDI
- Generic Name
- Stationary panoramic/tomographic dental x-ray system, digital FDA UDI
- Device Name
- Digital panoramic, cephalometric extra-oral X-ray system. Cephalometric arm is optional. FDA UDI
- Model / Reference
- Panoramic, cephalometric and tomographic X-ray equipment EUDAMED70BA0000, 70B1A000 EUDAMED70BR0000, 70B6R000 EUDAMEDhyperion X5 (2D CEPH) FDA UDI
- Description
- Digital panoramic, cephalometric extra-oral X-ray system. Cephalometric arm is optional. FDA UDI
Identifiers
- Catalog Number
- 70BA0000 FDA UDI
- Primary DI / UDI-DI
- 08033837932925 EUDAMEDFDA UDI08033837935537 EUDAMED
- Basic UDI-DI
- 803383793IMXRAYEXB001SY EUDAMED
- Direct Marketing DI
- 08033837932925 EUDAMED08033837935537 EUDAMED
- 510(k) Number
- FDA Product Code
- OAS FDA 510(k)MUH FDA UDI
- EMDN Code
- Z1103030102 EQUIPMENT FOR EXTRAORAL DENTAL RADIOLOGY, DIGITAL EUDAMED
- GMDN Term
- Stationary panoramic/tomographic dental x-ray system, digital FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA 510(k)FDA UDI
- Legislation / Framework
- 21 CFR Part 892.1750 FDA 510(k)
- Regulation Number
- 892.1750 FDA 510(k)872.1800 FDA UDI
- Market of Registration
- Italy EUDAMED
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
- 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
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
hyperion X5 by CEFLA s.c. — Class IIb — FDA_510K, MDR — listed in EUDAMED, FDA 510(k), FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K161900 | Class IIb | Active |
| FDA 510(k) | United States | FDA_510K | K200688 | Class IIb | Active |
| EUDAMED | European Union | CE/MDR | 803383793IMXRAYEXB001SY | Class IIb | Active |
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Manufacturer
- Manufacturer
- CEFLA s.c.
- EUDAMED SRN
- IT-MF-000009228
Sources (6)
- EUDAMED fb9bfc3f-8f96-4634-93d7-0a115a80418b 85 fields · synced Jul 29, 2026
- EUDAMED 607e0015-9014-408b-a3fa-70d4801eefb3 61 fields · synced May 18, 2026
- FDA 510(k) K200688 24 fields · synced May 18, 2026
- FDA UDI c08f4067-5293-4481-8098-2c6d38910e67 37 fields · synced May 29, 2026
- EUDAMED 607e0015-9014-408b-a3fa-70d4801eefb3-1 61 fields · synced Jul 25, 2026
- EUDAMED fb9bfc3f-8f96-4634-93d7-0a115a80418b-1 61 fields · synced Jul 29, 2026