Identity
- Trade Name
- Active Driver FDA UDI
- Generic Name
- Magnetic resonance elastography acoustic driver FDA UDI
- Model / Reference
- RESYS4001 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850011790168 FDA UDI
- 510(k) Number
- K201389 FDA UDI
- FDA Product Code
- LNH FDA UDI
- GMDN Term
- Magnetic resonance elastography acoustic driver FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1000 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
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Category: Magnetic resonance elastography acoustic driver
Active Driver by Resoundant — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Magnetic resonance elastography acoustic driver.
- SureWave Elastography — QUALITY ELECTRODYNAMICS LLC · Class II
- Resoundant Acoustic Driver System — Resoundant · Class II
Cleared under the same submission
K201389 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
- Resoundant
Sources (1)
- FDA UDI ebac4176-59f2-441a-8a82-f87242dab15b 33 fields · synced May 30, 2026