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ICTxp/9-5 MHz
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref P14562-21Model TRANSDUCER, ICTXP/9-5 MHZ
Identity
- Trade Name
- ICTxp/9-5 MHz EUDAMEDFDA UDI
- Generic Name
- Rectal/vaginal ultrasound imaging transducer FDA UDI
- Device Name
- TRANSDUCER, ICTXP/9-5 MHZ EUDAMEDDiagnostic Ultrasound Transducer FDA UDI
- Model / Reference
- TRANSDUCER, ICTXP/9-5 MHZ EUDAMEDP14562-21 EUDAMEDFDA UDI
- Description
- Diagnostic Ultrasound Transducer FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00841517101060 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00841517101060 EUDAMED
- 510(k) Number
- K152209 FDA UDI
- FDA Product Code
- ITX FDA UDI
- EMDN Code
- Z1104020201 ENDOCAVITARY ULTRASOUND PROBES, TWO–DIMENSIONAL EUDAMED
- GMDN Term
- Rectal/vaginal ultrasound imaging transducer FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1570 FDA UDI
- 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
ICTxp/9-5 MHz by Fujifilm Sonosite, Inc. — Class IIa — 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-00841517101060 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Fujifilm Sonosite, Inc.
- EUDAMED SRN
- US-MF-000001075
- Authorised Representative
- Fujifilm Sonosite B.V. NL-AR-000000046
Sources (2)
- EUDAMED 6d9ff6f1-3adc-43f4-b7bc-1d83fafd0a11 61 fields · synced Aug 4, 2026
- FDA UDI 34d88808-7872-4fbd-b9e3-654d1755c076 36 fields · synced May 30, 2026