Identity
- Trade Name
- Clarius Ultrasound Scanner FDA UDI
- Generic Name
- Hand-held ultrasound imaging system, body-surface FDA UDI
- Device Name
- Clarius brand C3 Premium scanner FDA UDI
- Model / Reference
- C3 Premium Scanner FDA UDI
- Description
- Clarius brand C3 Premium scanner FDA UDI
Identifiers
- Catalog Number
- 99-02-00009; 50-02-00003 FDA UDI
- Primary DI / UDI-DI
- 07540205000595 FDA UDI
- 510(k) Number
- K172385 FDA UDI
- FDA Product Code
- ITX FDA UDIIYN FDA UDIIYO FDA UDI
- GMDN Term
- Hand-held ultrasound imaging system, body-surface FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1570 FDA UDI892.1550 FDA UDI892.1560 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
No
FDA UDI
Category: Hand-held ultrasound imaging system, body-surface
Clarius Ultrasound Scanner by Clarius Mobile Health Corp — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K172385 also covers:
- Clarius Ultrasound Scanner — Clarius Mobile Health Corp
- Clarius Ultrasound Scanner — Clarius Mobile Health Corp
- Clarius Ultrasound Scanner — Clarius Mobile Health Corp
- Clarius Ultrasound Scanner — Clarius Mobile Health Corp
- Clarius Ultrasound Scanner — Clarius Mobile Health Corp
- Clarius Ultrasound Scanner — Clarius Mobile Health Corp
- Clarius Ultrasound Scanner — Clarius Mobile Health Corp
- Clarius Ultrasound Scanner — Clarius Mobile Health Corp
- Clarius Ultrasound Scanner — Clarius Mobile Health Corp
- Clarius Ultrasound Scanner — Clarius Mobile Health Corp
- Clarius Ultrasound Scanner — Clarius Mobile Health Corp
- Clarius Ultrasound Scanner — Clarius Mobile Health Corp
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
- Clarius Mobile Health Corp
Sources (1)
- FDA UDI 96bc54b3-51b5-461d-b6dd-8cd44606ecde 35 fields · synced Jun 6, 2026