Identity
- Trade Name
- Sonoscape FDA UDI
- Generic Name
- Oesophageal ultrasound imaging transducer, reusable FDA UDI
- Device Name
- MPTEE Ultrasonic Transducer (P10 Series) FDA UDI
- Model / Reference
- MPTEE FDA UDI
- Description
- MPTEE Ultrasonic Transducer (P10 Series) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06945868602840 FDA UDI
- 510(k) Number
- K173058 FDA UDI
- FDA Product Code
- IYN FDA UDIIYO FDA UDIITX FDA UDI
- GMDN Term
- Oesophageal ultrasound imaging transducer, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1550 FDA UDI892.1560 FDA UDI892.1570 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
No
FDA UDI
Category: Oesophageal ultrasound imaging transducer, reusable
Sonoscape by Sonoscape Medical Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Oesophageal ultrasound imaging transducer, reusable.
- V7M Transducer — SIEMENS MEDICAL SOLUTIONS USA, INC. · Class II
- TEEx/8-3 MHz — Fujifilm Sonosite, Inc. · Class II
- P8-2Ts Transducer(FDA-SJM) — Shenzhen Mindray Bio-Medical Electronics Co. · Class II
- Z6Ms Transducer — SIEMENS MEDICAL SOLUTIONS USA, INC. · Class II
- Tee probe — CHISON Medical Technologies Co., Ltd. · Class II
- MULTI-PLANE TRANSESOPHAGEAL TRANSDUCER — Canon Medical Systems Corporation · Class II
- TEEx/8-3 MHz — Fujifilm Sonosite, Inc. · Class II
- Tee probe — CHISON Medical Technologies Co., Ltd. · Class II
Cleared under the same submission
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| 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
- Sonoscape Medical Corp.
Sources (1)
- FDA UDI 91d8f95e-2c09-43d6-8b3e-c0f0ce03cf0c 34 fields · synced Jun 8, 2026