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NewTom 7G
EUDAMEDFDA UDIFDA 510(k)Class IIb (EU MDR)
Ref 70V10000Model Computed tomograph
by CEFLA s.c.
Identity
- Trade Name
- NewTom 7G EUDAMEDNewTom FDA UDI
- Generic Name
- Full-body CT system FDA UDI
- Device Name
- The device NewTom 7G is a cone beam computed tomography X-ray system. It is intended for diagnostic use obtaining geometric information and radiologic density from two-dimensional and three-dimensional images of anatomic particulars and objects in the examined area. FDA UDI
- Model / Reference
- Computed tomograph EUDAMED70V10000 EUDAMEDNewTom 7G FDA UDI
- Description
- The device NewTom 7G is a cone beam computed tomography X-ray system. It is intended for diagnostic use obtaining geometric information and radiologic density from two-dimensional and three-dimensional images of anatomic particulars and objects in the examined area. FDA UDI
Identifiers
- Catalog Number
- 70V10000 FDA UDI
- Primary DI / UDI-DI
- 08033837932994 EUDAMEDFDA UDI
- Basic UDI-DI
- 803383793IMXRAYCTB001QS EUDAMED
- Direct Marketing DI
- 08033837932994 EUDAMED
- 510(k) Number
- K220664 FDA UDI
- FDA Product Code
- JAK FDA UDIOAS FDA UDI
- EMDN Code
- Z11030699 COMPUTED TOMOGRAPHS (CT) - OTHER EUDAMED
- GMDN Term
- Full-body 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 7G 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 | K220664 | 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 10d831f7-6723-49b0-b4e2-88a32db9f2e2 61 fields · synced Jul 10, 2026
- FDA UDI 206466f7-abf4-414d-83f4-2cf3afd02f55 37 fields · synced May 30, 2026
- FDA 510(k) K220664 1 fields · synced May 18, 2026