Identity
- Trade Name
- AVANTSONIC FDA UDI
- Generic Name
- Bladder volume ultrasound imaging system FDA UDI
- Model / Reference
- AS-1 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06971759810001 FDA UDI
- 510(k) Number
- K230986 FDA UDI
- FDA Product Code
- IYO FDA UDI
- GMDN Term
- Bladder volume 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: Bladder volume ultrasound imaging system
Avantsonic by Avantsonic Technology Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Bladder volume ultrasound imaging system.
- BladderScan® — Verathon Inc. · Class II
- BladderScan® — Verathon Inc. · Class II
- Bladder Scanner — Suzhou PeakSonic Medical Technology Co., LTD. · Class II
- BBS Revolution™ — Dbmedx, Inc. · Class II
- Caresono — Caresono Technology Co., Ltd. · Class II
- Bladder Scanner — Suzhou PeakSonic Medical Technology Co., LTD. · Class II
- ScanPoint® — Verathon Inc. · Class II
- Caresono — Caresono Technology Co., Ltd. · Class II
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
- Avantsonic Technology Co., Ltd.
Sources (1)
- FDA UDI 7a91f9e8-52c5-460a-b37a-0fcb10499798 33 fields · synced May 30, 2026