Identity
- Trade Name
- Diagnostic Ultrasound System FDA UDI
- Generic Name
- General-purpose ultrasound imaging system FDA UDI
- Model / Reference
- Acclarix AX2 Super FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06944413811492 FDA UDI
- FDA Product Code
- IYO FDA UDIIYN FDA UDIITX FDA UDI
- GMDN Term
- General-purpose ultrasound imaging system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1560 FDA UDI892.1550 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
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: General-purpose ultrasound imaging system
Diagnostic Ultrasound System by Edan Instruments, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K192791 also covers:
- Diagnostic Ultrasound System — Edan Instruments, Inc.
- Diagnostic Ultrasound System — Edan Instruments, Inc.
- Diagnostic Ultrasound System — Edan Instruments, Inc.
- Diagnostic Ultrasound System — Edan Instruments, Inc.
- Diagnostic Ultrasound System — Edan Instruments, Inc.
- Diagnostic Ultrasound System — Edan Instruments, Inc.
- Needle Guide Bracket Kit — Edan Instruments, Inc.
- Needle Guide Bracket Kit — Edan Instruments, Inc.
- Needle Guide Bracket Kit — Edan Instruments, Inc.
K202856 also covers:
- Diagnostic Ultrasound System — Edan Instruments, Inc.
- Diagnostic Ultrasound System — Edan Instruments, Inc.
- Diagnostic Ultrasound System — Edan Instruments, Inc.
- Diagnostic Ultrasound System — Edan Instruments, Inc.
- Diagnostic Ultrasound System — Edan Instruments, Inc.
- Diagnostic Ultrasound System — Edan Instruments, Inc.
- Diagnostic Ultrasound System — Edan Instruments, Inc.
- Diagnostic Ultrasound System — Edan Instruments, Inc.
- Diagnostic Ultrasound System — Edan Instruments, Inc.
- Diagnostic Ultrasound System — Edan Instruments, Inc.
- Needle Guide Bracket Kit — Edan Instruments, Inc.
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
- Edan Instruments, Inc.
Sources (1)
- FDA UDI 09a20b2c-2dea-47c4-8f0d-010883fd794f 33 fields · synced Jun 8, 2026