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Venue
FDA UDIClass II (US FDA UDI)
by GE Medical Systems Ultrasound & Primary Care Diagnostics LLC
Identity
- Trade Name
- Venue FDA UDI
- Generic Name
- General-purpose ultrasound imaging system FDA UDI
- Device Name
- Venue R3 MD eDelivery or Physical Upgrade FDA UDI
- Model / Reference
- R3 UPG FDA UDI
- Description
- Venue R3 MD eDelivery or Physical Upgrade FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00195278005830 FDA UDI
- 510(k) Number
- K202132 FDA UDI
- FDA Product Code
- IYO FDA UDIIYN FDA UDIITX FDA UDI
- GMDN Term
- General-purpose ultrasound imaging system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1560 FDA UDI892.1550 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
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: General-purpose ultrasound imaging system
Venue by GE Medical Systems Ultrasound & Primary Care Diagnostics LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K202132 also covers:
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
Sources (1)
- FDA UDI 43f3a75b-3e14-45fb-b778-9fdfb7207aeb 35 fields · synced Jun 4, 2026