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NewTom 5G XL
EUDAMEDFDA UDIFDA 510(k)Class IIb (EU MDR)
Ref P70720008Model Computed tomograph
by CEFLA s.c.
Identity
- Trade Name
- NewTom 5G XL EUDAMEDNewTom FDA UDI
- Generic Name
- Limited-view-field CT system FDA UDI
- Device Name
- X-ray imaging device comprising an X-ray acquisition system, for producing two and three dimensional views for computation and display. FDA UDI
- Model / Reference
- Computed tomograph EUDAMEDP70720008 EUDAMEDNewTom 5G XL FDA UDI
- Description
- X-ray imaging device comprising an X-ray acquisition system, for producing two and three dimensional views for computation and display. FDA UDI
Identifiers
- Catalog Number
- P70720008 FDA UDI
- Primary DI / UDI-DI
- 08033837931379 EUDAMEDFDA UDI
- Basic UDI-DI
- 803383793IMXRAYCTB001QS EUDAMED
- Direct Marketing DI
- 08033837931379 EUDAMED
- 510(k) Number
- K183448 FDA UDI
- FDA Product Code
- JAK FDA UDIOAS FDA UDI
- EMDN Code
- Z11030699 COMPUTED TOMOGRAPHS (CT) - OTHER EUDAMED
- GMDN Term
- Limited-view-field CT system FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1750 FDA UDI
- Market of Registration
- Italy EUDAMED
- 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
NewTom 5G XL by CEFLA s.c. — Class IIb — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
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 | K183448 | Class IIb | Active |
| EUDAMED | European Union | CE/MDR | 803383793IMXRAYCTB001QS | Class IIb | Active |
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Manufacturer
- Manufacturer
- CEFLA s.c.
- EUDAMED SRN
- IT-MF-000009228
Sources (3)
- EUDAMED 29ec5d78-22c0-4588-8a59-79029a5643bd 61 fields · synced Jul 9, 2026
- FDA UDI cc662afa-7733-4ee3-bb96-e26fff5d8a71 37 fields · synced May 25, 2026
- FDA 510(k) K183448 1 fields · synced May 18, 2026