Identity
- Trade Name
- SonoScape FDA UDI
- Generic Name
- Oesophageal ultrasound imaging transducer, reusable FDA UDI
- Device Name
- MPTEE Ultrasonic Transducer (P50) FDA UDI
- Model / Reference
- MPTEE FDA UDI
- Description
- MPTEE Ultrasonic Transducer (P50) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06945868602581 FDA UDI
- 510(k) Number
- K170999 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
K170999 also covers:
- SonoScape — SONOSCAPE MEDICAL CORP.
- SonoScape — SONOSCAPE MEDICAL CORP.
- SonoScape — SONOSCAPE MEDICAL CORP.
- SonoScape — SONOSCAPE MEDICAL CORP.
- SonoScape — SONOSCAPE MEDICAL CORP.
- SonoScape — SONOSCAPE MEDICAL CORP.
- SonoScape — SONOSCAPE MEDICAL CORP.
- SonoScape — SONOSCAPE MEDICAL CORP.
- SonoScape — SONOSCAPE MEDICAL CORP.
- SonoScape — SONOSCAPE MEDICAL CORP.
- Sonoscape — SONOSCAPE MEDICAL CORP.
- sonoscape — SONOSCAPE MEDICAL CORP.
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 |
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Manufacturer
- Manufacturer
- Sonoscape Medical Corp.
Sources (1)
- FDA UDI de60a9a9-a497-4d80-871e-dac0ae226415 34 fields · synced May 31, 2026