Identity
- Trade Name
- C10-3 Curved Array Tranducer 86888-30 FDA UDI
- Generic Name
- Extracorporeal ultrasound imaging transducer, hand-held FDA UDI
- Model / Reference
- Z124-30 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06944904092607 FDA UDI
- 510(k) Number
- K151175 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
MR Unsafe FDA UDI
Category: Extracorporeal ultrasound imaging transducer, hand-held
C10-3 Curved Array Tranducer 86888-30 by Shenzhen Mindray Bio-Medical Electronics Co. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K151175 also covers:
- ViewMate™ — ST. JUDE MEDICAL, INC.
- A2CW Continuous Wave Transducer — Shenzhen Mindray Bio-Medical Electronics Co.
- A2CW Continuous Wave Transducer — Shenzhen Mindray Bio-Medical Electronics Co.
- A5CW Continuous Wave Transducer — Shenzhen Mindray Bio-Medical Electronics Co.
- C4-1 Curved Array Tranducer 86333-30 — Shenzhen Mindray Bio-Medical Electronics Co.
- C6-2 Curved Array Tranducer 84009-30 — Shenzhen Mindray Bio-Medical Electronics Co.
- C8-3 3D Curved Array Transducer — Shenzhen Mindray Bio-Medical Electronics Co.
- C9-3 Curved Array Tranducer 85222-30 — Shenzhen Mindray Bio-Medical Electronics Co.
- C9-3sp Curved Array Transducer — Shenzhen Mindray Bio-Medical Electronics Co.
- DVD, Field Upgrade — Shenzhen Mindray Bio-Medical Electronics Co.
- E9-3 3D Curved Array Transdcuer — Shenzhen Mindray Bio-Medical Electronics Co.
- E9-3 Endocavitary Tranducer 87444-00 — Shenzhen Mindray Bio-Medical Electronics Co.
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
- Shenzhen Mindray Bio-Medical Electronics Co.
Sources (1)
- FDA UDI 04674321-dbef-44d7-8ea3-bce2563b78a7 33 fields · synced Jun 1, 2026