Identity
- Trade Name
- 4D Assembly Kit FDA UDI
- Generic Name
- General-purpose ultrasound imaging system FDA UDI
- Model / Reference
- 115-034333-00 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06944904089720 FDA UDI
- 510(k) Number
- K162267 FDA UDI
- FDA Product Code
- IYN FDA UDI
- GMDN Term
- General-purpose ultrasound imaging system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1550 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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Unsafe FDA UDI
Category: General-purpose ultrasound imaging system
4D Assembly Kit 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
K162267 also covers:
- C5-1U Ultrasonic Probe(FDA) — Shenzhen Mindray Bio-Medical Electronics Co.
- CW Module Kit — Shenzhen Mindray Bio-Medical Electronics Co.
- D8-4U Ultrasonic Probe(FDA) — Shenzhen Mindray Bio-Medical Electronics Co.
- DE10-3U Ultrasonic Probe(FDA) — Shenzhen Mindray Bio-Medical Electronics Co.
- DE11-3U Ultrasonic Probe(FDA) — Shenzhen Mindray Bio-Medical Electronics Co.
- ECG Module Kit(AHA) — Shenzhen Mindray Bio-Medical Electronics Co.
- Foot Switch Module — Shenzhen Mindray Bio-Medical Electronics Co.
- Gel Warmer Kit — Shenzhen Mindray Bio-Medical Electronics Co.
- Gel Warmer Kit(with Left Rack) — Shenzhen Mindray Bio-Medical Electronics Co.
- Gel Warmer Kit(with Right Rack) — Shenzhen Mindray Bio-Medical Electronics Co.
- Heater for Coupling Gel — Shenzhen Mindray Bio-Medical Electronics Co.
- L10-3s Ultrasonic Probe(FDA) — 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 7241ea9a-8723-4756-a6ad-b6aa0c926c5b 34 fields · synced May 30, 2026