Identity
- Trade Name
- s5i Imaging System Workstation FDA UDI
- Generic Name
- Cardiovascular ultrasound imaging system FDA UDI
- Model / Reference
- 807401001 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00184360000686 FDA UDI
- 510(k) Number
- K071554 FDA UDI
- FDA Product Code
- IYO FDA UDI
- GMDN Term
- Cardiovascular ultrasound imaging system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1560 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
Category: Cardiovascular ultrasound imaging system
s5i Imaging System Workstation by Volcano Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Cardiovascular ultrasound imaging system.
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- iLab Ultrasound Imaging System — Boston Scientific · Class II
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- AVVIGO™+ — Boston Scientific · Class II
- Medistim System Activation Card — Medi-Stim Asa · Class II
- AVVIGO™+ — Boston Scientific · Class II
Cleared under the same submission
K071554 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
- Volcano Corporation
Sources (1)
- FDA UDI 4fd2bba4-c7a2-4742-86f0-148c223065bc 33 fields · synced Jun 8, 2026