Identity
- Trade Name
- DC-8 EXP Ultrasound system FDA UDI
- Generic Name
- General-purpose ultrasound imaging system FDA UDI
- Model / Reference
- DC-8 EXP FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06944904050324 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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Category: General-purpose ultrasound imaging system
DC-8 EXP Ultrasound system 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
K150080 also covers:
- 4D and TEE Driver Module Board — Shenzhen Mindray Bio-Medical Electronics Co.
- Battery Kit — Shenzhen Mindray Bio-Medical Electronics Co.
- C11-3E Ultrasonic Transducer(FDA) — Shenzhen Mindray Bio-Medical Electronics Co.
- C5-2E Ultrasonic Transducer(FDA) — Shenzhen Mindray Bio-Medical Electronics Co.
- C7-3EUltrasonic Transducer(FDA) — Shenzhen Mindray Bio-Medical Electronics Co.
- CB10-4E Ultrasonic Transducer(FDA) — Shenzhen Mindray Bio-Medical Electronics Co.
- CW Module Kit — Shenzhen Mindray Bio-Medical Electronics Co.
- D6-2E Ultrasonic Transducer(FDA) — Shenzhen Mindray Bio-Medical Electronics Co.
- DC-8 Ultrasound system — Shenzhen Mindray Bio-Medical Electronics Co.
- DE10-3E Ultrasonic Probe(FDA) — Shenzhen Mindray Bio-Medical Electronics Co.
- Heater for Coupling Gel(inc cable) — Shenzhen Mindray Bio-Medical Electronics Co.
- Inner DVR Kit — Shenzhen Mindray Bio-Medical Electronics Co.
K170277 also covers:
- DC-8 CV Diagnostic Ultrasound System — Shenzhen Mindray Bio-Medical Electronics Co.
- DC-8 PRO Diagnostic Ultrasound System — Shenzhen Mindray Bio-Medical Electronics Co.
- DC-8 Ultrasound system — Shenzhen Mindray Bio-Medical Electronics Co.
- DC-8S Diagnostic Ultrasound System — Shenzhen Mindray Bio-Medical Electronics Co.
- UltraView Disk — 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 726c217d-f6dc-4f62-9bc2-5d4015a19bcf 34 fields · synced Jun 6, 2026