Identity
- Trade Name
- C35xp/8-3 MHz FDA UDI
- Generic Name
- Extracorporeal ultrasound imaging transducer, hand-held FDA UDI
- Device Name
- Diagnostic Ultrasound Transducer FDA UDI
- Model / Reference
- P19617-20A FDA UDI
- Description
- Diagnostic Ultrasound Transducer FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00841517101046 FDA UDI
- 510(k) Number
- K152209 FDA UDI
- FDA Product Code
- ITX FDA UDI
- GMDN Term
- Extracorporeal ultrasound imaging transducer, hand-held FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1570 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Category: Extracorporeal ultrasound imaging transducer, hand-held
C35xp/8-3 MHz by Fujifilm Sonosite, Inc. — Class II — MDR, MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Extracorporeal ultrasound imaging transducer, hand-held.
- 6C2 Transducer — SIEMENS MEDICAL SOLUTIONS USA, INC. · Class II
- Biim Android App, P1.3 — Biim Ultrasound AS · Class II
- C6-2 Transducer — SIEMENS MEDICAL SOLUTIONS USA, INC. · Class II
- Battery Charger AU, Biim Ultrasound — Biim Ultrasound AS · Class II
- SonoScape — SONOSCAPE MEDICAL CORP. · Class II
- 4C1 Transducer — SIEMENS MEDICAL SOLUTIONS USA, INC. · Class II
- UST-5419 — FUJIFILM Corporation · Class II
- P4-12 — SAMSUNG MEDISON CO., LTD · Class II
Cleared under the same submission
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| EUDAMED | European Union | MDD | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Fujifilm Sonosite, Inc.
Sources (2)
- FDA UDI 0ee0a7e9-81be-452b-a4fa-373317bddf81 36 fields · synced Jun 18, 2026
- EUDAMED 1 fields · synced Jun 3, 2026