← Back to catalogue
FUJIFILM Persona CS
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref 95 02 000 / 95 04 000 / 95 07 000 / 95 09 000Model Persona CS
Identity
- Trade Name
- FUJIFILM Persona CS EUDAMEDFUJIFILM Healthcare Americas Corporation FDA UDI
- Generic Name
- Mobile general-purpose fluoroscopic x-ray system, digital FDA UDI
- Device Name
- Persona CS EUDAMEDThis is a mobile X-ray device with a Flat Panel detector used for radiological guidance and visualization during diagnostic, interventional and surgical procedures. In particular, the device is to be applied during orthopedic, neuro, abdominal, vascular, thoracic and cardiac procedures. It can be used on all patients except pediatric patients within the limit of the device. FDA UDI
- Model / Reference
- Persona CS EUDAMEDFDA UDI95 02 000 / 95 04 000 / 95 07 000 / 95 09 000 EUDAMED
- Description
- This is a mobile X-ray device with a Flat Panel detector used for radiological guidance and visualization during diagnostic, interventional and surgical procedures. In particular, the device is to be applied during orthopedic, neuro, abdominal, vascular, thoracic and cardiac procedures. It can be used on all patients except pediatric patients within the limit of the device. FDA UDI
Identifiers
- Catalog Number
- 95 02 000 FDA UDI
- Primary DI / UDI-DI
- 08055186670389 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08055186670389 EUDAMED
- 510(k) Number
- K211777 FDA UDI
- FDA Product Code
- OWB FDA UDIOXO FDA UDI
- EMDN Code
- Z11039017 MOBILE RADIOSCOPIC UNITS EUDAMED
- GMDN Term
- Mobile general-purpose fluoroscopic x-ray system, digital FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1650 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
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
FUJIFILM Persona CS by A.T.S. Applicazione Tecnologie Speciali s.r.l. — Class IIb — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-08055186670389 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- A.T.S. Applicazione Tecnologie Speciali s.r.l.
- EUDAMED SRN
- IT-MF-000010734
Sources (2)
- EUDAMED 6303b442-d28d-4268-8272-f533b2a1f59c 61 fields · synced Jun 17, 2026
- FDA UDI ebf02ed2-082b-41ac-a47a-5ad99a3a29a9 35 fields · synced May 30, 2026