Identity
- Trade Name
- Z6Ms Transducer FDA UDI
- Generic Name
- Oesophageal ultrasound imaging transducer, reusable FDA UDI
- Model / Reference
- 10436113 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04056869003634 FDA UDI
- 510(k) Number
- K141846 FDA UDI
- FDA Product Code
- ITX FDA UDI
- GMDN Term
- Oesophageal ultrasound imaging transducer, reusable 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
No
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
Z6Ms Transducer by Siemens Medical Solutions Usa, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Oesophageal ultrasound imaging transducer, reusable.
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- TEEx/8-3 MHz — Fujifilm Sonosite, Inc. · Class II
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- Sonoscape — SONOSCAPE MEDICAL CORP. · Class II
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Cleared under the same submission
K141846 also covers:
- 4C1 Transducer — SIEMENS MEDICAL SOLUTIONS USA, INC.
- 4V1c Transducer — SIEMENS MEDICAL SOLUTIONS USA, INC.
- 4V1c Transducer — SIEMENS MEDICAL SOLUTIONS USA, INC.
- 4V1c Transducer — SIEMENS MEDICAL SOLUTIONS USA, INC.
- 6C2 Transducer — SIEMENS MEDICAL SOLUTIONS USA, INC.
- ACUSON X600 Diagnostic Ultrasound System — SIEMENS MEDICAL SOLUTIONS USA, INC.
- ACUSON X700 Diagnostic Ultrasound System — SIEMENS MEDICAL SOLUTIONS USA, INC.
- C6F2 Transducer — SIEMENS MEDICAL SOLUTIONS USA, INC.
- C7F2 Transducer — SIEMENS MEDICAL SOLUTIONS USA, INC.
- C8F3 Transducer — SIEMENS MEDICAL SOLUTIONS USA, INC.
- CH5-2 Transducer — SIEMENS MEDICAL SOLUTIONS USA, INC.
- EC9-4 Transducer — SIEMENS MEDICAL SOLUTIONS USA, INC.
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
- Siemens Medical Solutions Usa, Inc.
Sources (1)
- FDA UDI 2190477e-0871-4f66-892c-66c0f901c0e5 34 fields · synced Jun 8, 2026