Identity
- Trade Name
- Amirix Imaging FDA UDI
- Generic Name
- X-ray system tube FDA UDI
- Device Name
- Diagnostic Mammography X-Ray Tube Assembly FDA UDI
- Model / Reference
- LM33-T Diagnostic X-Ray Tube FDA UDI
- Description
- Diagnostic Mammography X-Ray Tube Assembly FDA UDI
Identifiers
- Catalog Number
- LM33-T FDA UDI
- Primary DI / UDI-DI
- 00860013147662 FDA UDI
- FDA Product Code
- ITY FDA UDI
- GMDN Term
- X-ray system tube FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 892.1760 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
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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: X-ray system tube
Amirix Imaging by Amirix Imaging — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as X-ray system tube.
- Medical CT X-Ray Tube — Wuxi Guochen Medical Technology Co., Ltd. · Class I
- SMARTBEAM — Beijing Smartbeam Technology Co., LTD · Class I
- Medical CT X-Ray Tube Assembly — Wuxi Guochen Medical Technology Co., Ltd. · Class I
- Richardson Electronics — RICHARDSON ELECTRONICS · Class I
- Medical diagnostic rotating anode X-ray tube — Beijing Smartbeam Medical Devices Co., LTD · Class I
- SMARTBEAM — Beijing Smartbeam Technology Co., LTD · Class I
- Medical CT X-Ray Tube Assembly — Wuxi Guochen Medical Technology Co., Ltd. · Class I
- Mingwei — MingWei Medical Technology(Suzhou)Co., LTD · Class I
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 I | Pending data |
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Manufacturer
- Manufacturer
- Amirix Imaging
Sources (1)
- FDA UDI 70bdbc9f-c6f8-4472-af27-343d8b957504 34 fields · synced May 30, 2026