Port-X IV
FDA 510(k)FDA UDIEUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- Genoray FDA UDI
- Generic Name
- Portable basic diagnostic x-ray system, digital FDA UDI
- Device Name
- PORT-X IV EUDAMED
- Model / Reference
- 206 EUDAMEDPORT-X IV FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08809244061202 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08809244061202 EUDAMED
- 510(k) Number
- FDA Product Code
- EHD FDA 510(k)FDA UDI
- EMDN Code
- Z1103040101 EQUIPMENT FOR CONVENTIONAL ENDORAL RADIOLOGY EUDAMED
- GMDN Term
- Portable basic diagnostic x-ray system, digital FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA 510(k)FDA UDI
- Legislation / Framework
- 21 CFR Part 872.1800 FDA 510(k)
- Regulation Number
- 872.1800 FDA 510(k)FDA UDI
- Market of Registration
- Germany EUDAMED
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
Yes
The Port-X IV is an extraoral dental X-ray unit with an integrated timer, designed for capturing high-quality radiographic images of dental structures. Classified as a Class II device under FDA regulations, it is intended for use in dental diagnostics, providing precise imaging for oral health assessments.
This portable device is powered by a rechargeable battery, enabling up to 400 exposures per full charge with a 0.5-second exposure time. Supplied as a reusable medical device, it adheres to the Medical Device Directive (MDD) and is regulated under FDA 510(k) clearance for dental applications. Storage and handling follow standard radiographic safety protocols to ensure optimal performance and compliance with regulatory standards.
Frequently asked questions
How many radiographic exposures can the Port-X IV provide on a single charge, and what is the typical exposure time per image?
The Port-X IV is powered by a rechargeable battery and can deliver up to 400 radiographic exposures per full charge. Each exposure has a fixed duration of 0.5 seconds, ensuring consistent imaging performance for dental diagnostics.
Is the Port-X IV intended for single-use or reusable applications, and what are the implications for maintenance?
The Port-X IV is explicitly described as a reusable medical device. Since it is not single-use, proper cleaning, disinfection, and maintenance protocols must be followed to ensure sterility and optimal performance between uses, adhering to standard radiographic safety guidelines.
What regulatory pathways does the Port-X IV follow for approval, and which governing bodies have authorized its use?
The Port-X IV is regulated under the FDA 510(k) clearance pathway for dental applications, classified as a Class II device. It also complies with the Medical Device Directive (MDD) in Europe, ensuring its use is authorized in both the U.S. and EU markets under these frameworks.
How portable is the Port-X IV, and what power source does it rely on for operation?
The Port-X IV is designed as a portable extraoral dental X-ray unit, making it suitable for use in various clinical settings beyond fixed installations. It operates using a rechargeable battery, eliminating the need for constant access to wall power while maintaining functionality for up to 400 exposures per charge.
What safety protocols should be followed for storage and handling of the Port-X IV?
The Port-X IV must be stored and handled according to standard radiographic safety protocols to ensure optimal performance and compliance with regulatory standards. This includes proper shielding, environmental controls, and adherence to guidelines for X-ray equipment to minimize radiation exposure risks.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: GENORAY, GENORAY PORT-X IV USER MANUAL Pdf Download | ManualsLib, GENORAY Europe, Genoray PORT-X IV Manuals | ManualsLib, PDF Portable X-ray system PORT-X IV - Bionet America
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K172810 | Class II | Active |
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Manufacturer
- Manufacturer
- Genoray Co., Ltd.
Sources (3)
- FDA 510(k) K172810 24 fields · synced Sep 18, 2026
- FDA UDI 93554e7a-50e8-4b20-90bd-411b0b51c837 33 fields · synced May 30, 2026
- EUDAMED 87406871-e74e-4dea-a234-f26063f7664d 61 fields · synced Jul 9, 2026