Identity
- Trade Name
- ExactVu High Resolution Micro-Ultrasound System FDA UDI
- Generic Name
- General-purpose ultrasound imaging system FDA UDI
- Device Name
- The ExactVu high resolution micro-ultrasound system is intended for use by qualified medical professionals for diagnostic ultrasound imaging, data processing and guidance of puncture and biopsy. The ExactVu System is comprised of transducers responsible for ultrasound signal generation and recording, a needle guide and a main unit that controls the transducers, processes the acoustic data, and processes and displays images. FDA UDI
- Model / Reference
- 1.0 FDA UDI
- Description
- The ExactVu high resolution micro-ultrasound system is intended for use by qualified medical professionals for diagnostic ultrasound imaging, data processing and guidance of puncture and biopsy. The ExactVu System is comprised of transducers responsible for ultrasound signal generation and recording, a needle guide and a main unit that controls the transducers, processes the acoustic data, and processes and displays images. FDA UDI
Identifiers
- Catalog Number
- EV-SYS-120 FDA UDI
- Primary DI / UDI-DI
- 00628055481027 FDA UDI
- 510(k) Number
- K162972 FDA UDI
- FDA Product Code
- IYO FDA UDI
- GMDN Term
- General-purpose 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
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: General-purpose ultrasound imaging system
ExactVu High Resolution Micro-Ultrasound System by Exact Imaging — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K162972 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
- Exact Imaging
Sources (1)
- FDA UDI ecea8a4c-944a-4b2b-9d9b-c4846b537e24 35 fields · synced May 30, 2026