Identity
- Trade Name
- Transonic FDA UDI
- Generic Name
- Noninvasive vascular ultrasound system, line-powered FDA UDI
- Model / Reference
- ADT1010-40 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00877466000468 FDA UDI
- 510(k) Number
- K021571 FDA UDI
- FDA Product Code
- MQS FDA UDI
- GMDN Term
- Noninvasive vascular ultrasound system, line-powered FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.5820 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Noninvasive vascular ultrasound system, line-powered
Transonic by Transonic Systems Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Noninvasive vascular ultrasound system, line-powered.
- NovaGuide™ Intelligent Ultrasound System — Novasignal Corporation · Class II
- Varia TCD — NEUROCHAOS SOLUTIONS INC · Class II
- Smartdop XT6 — Koven Technology, Inc. · Class II
- Hokanson — D. E. Hokanson, Inc. · Class II
- Sono TT Ultrasonic Flowcomputer — em-tec GmbH · Class II
- Smartdop XT — Koven Technology, Inc. · Class II
- NovaBot Automated Headset — Novasignal Corporation · Class II
- VascuLab — Us Vascular, LLC · 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Transonic Systems Inc.
Sources (1)
- FDA UDI 3300a34e-bde4-41af-ae5c-112939946ebd 33 fields · synced May 30, 2026