Identity
- Trade Name
- AcuViz Pocket FDA UDI
- Generic Name
- Hand-held ultrasound imaging system, body-surface FDA UDI
- Model / Reference
- SC1 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800076600096 FDA UDI
- 510(k) Number
- K210468 FDA UDI
- FDA Product Code
- IYO FDA UDIITX FDA UDI
- GMDN Term
- Hand-held ultrasound imaging system, body-surface FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1560 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Hand-held ultrasound imaging system, body-surface
AcuViz Pocket by Fcu — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K210468 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
- Manufacturer
- Fcu
Sources (1)
- FDA UDI 4211ca7c-514a-4c3e-9edf-9e94dd9dbb83 34 fields · synced May 30, 2026