POCT22 Diagnostic X-Ray Equipment
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- POCT22 EUDAMED
- Device Name
- Diagnostic X-ray Equipment EUDAMED
- Model / Reference
- POCT22, SUPER05, XR(G) EUDAMED711 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974721257118 EUDAMED
- Basic UDI-DI
- 697472125RAY980042C EUDAMED
- 510(k) Number
- K252909 FDA 510(k)
- FDA Product Code
- EHD FDA 510(k)
- EMDN Code
- Z1103040101 EQUIPMENT FOR CONVENTIONAL ENDORAL RADIOLOGY EUDAMED
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 872.1800 FDA 510(k)
- Regulation Number
- 872.1800 FDA 510(k)
- Market of Registration
- Germany EUDAMED
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Clinical & Handling
Sterile
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
The POCT22 is an extraoral dental X-ray unit with a built-in timer, designed for capturing high-resolution images of teeth and surrounding structures. Classified as a Class II device under FDA regulations, it is intended for use in dental radiography to aid in diagnosis and treatment planning.
This equipment is supplied as a reusable medical device, intended for use in dental offices or clinics. It is not sterile upon delivery and must be cleaned and maintained according to manufacturer guidelines. The device complies with FDA 510(k) clearance (K252909) and is regulated under the Medical Devices Regulation (MDR) in the EU. Multiple FEI numbers indicate its registration in various international markets.
Frequently asked questions
Is the POCT22 X-ray machine designed for single-use or can it be reused in a clinical setting?
The POCT22 is supplied as a reusable dental X-ray unit, not intended for single-use. Since it is not sterile upon delivery, it must be thoroughly cleaned and maintained according to the manufacturer’s guidelines before each use to ensure safety and hygiene in dental offices or clinics.
What regulatory pathways has the POCT22 followed for market authorization in the U.S. and EU?
The POCT22 has received FDA 510(k) clearance under the traditional review pathway (K252909) and is classified as a Class II device for dental radiography. In the EU, it complies with the Medical Devices Regulation (MDR), reflecting its regulatory approvals in both markets.
Does the POCT22 come pre-sterilized, or does it require sterilization before first use?
The POCT22 is not sterile upon delivery and must be cleaned and maintained per the manufacturer’s instructions before use. Sterilization is not mentioned in the specifications, so standard dental office cleaning protocols should apply.
What types of dental imaging does the POCT22 support, and is it limited to specific anatomical areas?
The POCT22 is an extraoral dental X-ray unit specifically designed for capturing high-resolution images of teeth and surrounding structures. While it is intended for dental radiography, its exact anatomical focus (e.g., panoramic, cephalometric, or sectional views) is not detailed beyond general dental use.
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: Diagnostic X-Ray Equipment Model POCT22 (K252909) - Innolitics, K252909 FDA 510(k) - Diagnostic X-Ray Equipment Model POCT22, POCT22 X-Ray Equipment | Medical Device Navigator, Diagnostic X-Ray Equipment Model POCT22 — FDA K252909, Diagnostic X-Ray Equipment Model POCT22 510(k) K252909 - fda.report
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K252909 | Class II | Active |
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Manufacturer
- Manufacturer
- Ningbo Runyes Medical Instrument Co., Ltd.
Sources (2)
- FDA 510(k) K252909 24 fields · synced Sep 18, 2026
- EUDAMED 95fb15d4-0680-4efd-b1b0-137dce0ffbe2 61 fields · synced Jul 14, 2026