Identity
- Trade Name
- Genoray FDA UDI
- Generic Name
- Portable basic diagnostic x-ray system, digital FDA UDI
- Device Name
- The Multiple Name for PORT-XII is ZEN-PX2. FDA UDI
- Model / Reference
- PORT-XII FDA UDI
- Description
- The Multiple Name for PORT-XII is ZEN-PX2. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08809244061035 FDA UDI
- 510(k) Number
- K063121 FDA UDI
- FDA Product Code
- EHD FDA UDI
- GMDN Term
- Portable basic diagnostic x-ray system, digital FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.1800 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
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: Portable basic diagnostic x-ray system, digital
Genoray by Genoray Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Portable basic diagnostic x-ray system, digital.
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- X-ray Flat Panel Detector — CareRay Digital Medical Technology Co., Ltd. · Class II
- AcuityPDR — Radmedix, LLC · Class II
- AcuityPDR — Radmedix, LLC · Class II
- Portable X-Ray System — KONICA MINOLTA MEDICAL IMAGING U.S.A., INC. · 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 |
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Manufacturer
- Manufacturer
- Genoray Co., Ltd.
Sources (1)
- FDA UDI 4b210d49-751c-405b-b16d-7a9cbe946fce 34 fields · synced Jun 1, 2026