Identity
- Trade Name
- AMRAD Medical FDA UDI
- Generic Name
- Mobile general-purpose fluoroscopic x-ray system, digital FDA UDI
- Device Name
- This is a mobile X-ray device with a Flat Panel detector used for radiological guidance and visualization during diagnostic, interventional and surgical procedures. In particular, the device is to be applied during orthopedic, neuro, abdominal, vascular, thoracic and cardiac procedures. It can be used on all patients except pediatric patients within the limit of the device. FDA UDI
- Model / Reference
- Agility Plus FDA UDI
- Description
- This is a mobile X-ray device with a Flat Panel detector used for radiological guidance and visualization during diagnostic, interventional and surgical procedures. In particular, the device is to be applied during orthopedic, neuro, abdominal, vascular, thoracic and cardiac procedures. It can be used on all patients except pediatric patients within the limit of the device. FDA UDI
Identifiers
- Catalog Number
- 74 10 000-2 FDA UDI
- Primary DI / UDI-DI
- 08055186670426 FDA UDI
- 510(k) Number
- K182086 FDA UDI
- FDA Product Code
- OWB FDA UDIOXO FDA UDI
- GMDN Term
- Mobile general-purpose fluoroscopic x-ray system, digital FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1650 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: Mobile general-purpose fluoroscopic x-ray system, digital
AMRAD Medical by A.t.s. Applicazione Tecnologie Speciali Srl — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Mobile general-purpose fluoroscopic x-ray system, digital.
- Ziehm Vision RFD 3D — Ziehm Imaging, Inc. · Class II
- SURGIVISIO DEVICE — ECENTIAL ROBOTICS · Class II
- OEC — GE Hualun Medical Systems Co., Ltd · Class II
- Flat panel sensor holder — FUJIFILM Corporation · Class II
- Ziehm Vision FD — Ziehm Imaging, Inc. · Class II
- FDR CROSS — FUJIFILM Corporation · Class II
- SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE-INTENSIFIED — Gemss Medical Systems Co., Ltd. · Class II
- Zenition — Philips Medical Systems Nederland B.V. · Class II
Cleared under the same submission
K182086 also covers:
- AMRAD Medical — A.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRL
- AMRAD Medical — A.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRL
- AMRAD Medical — A.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRL
- FUJIFILM Medical Systems U.S.A. Inc. — A.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRL
- FUJIFILM Medical Systems U.S.A. Inc. — A.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRL
- FUJIFILM Medical Systems U.S.A. Inc. — A.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRL
- FUJIFILM Medical Systems U.S.A. Inc. — A.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRL
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
- A.t.s. Applicazione Tecnologie Speciali Srl
Sources (1)
- FDA UDI cf61ba71-a3d0-4338-a689-b5878c5a577c 35 fields · synced May 30, 2026