← Back to catalogue

WeSensor

FDA 510(k)

Class II (US FDA 510(k))

510(k) K230916

by Picopack, Inc.

Identifiers

510(k) Number
K230916 FDA 510(k)
FDA Product Code
MUH FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 872.1800 FDA 510(k)
Regulation Number
872.1800 FDA 510(k)
Advisory Committee
Dental FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The WeSensor F350A is an intraoral digital X-ray sensor designed for dental imaging. It converts X-ray exposure into digital signals, enabling high-resolution radiographic images of teeth and surrounding structures. The device incorporates a scintillator composed of Thallium-doped Cesium Iodide (CsI:Tl) and Sodium Iodide (NaI:Tl), paired with an additional filter layer to optimize image quality and reduce noise. This technology supports precise diagnostic evaluations in dental practice.

The WeSensor F350A is supplied as a reusable intraoral sensor system, including a USB-connected sensor, proprietary software, and an accessory holder. It is classified as a Class II medical device under FDA regulations (21 CFR 872.1800) and holds a 510(k) clearance for dental applications. The sensor measures 43.0 mm × 33.0 mm × 12.0 mm and is intended for use in controlled clinical environments. No MRI safety or sterility specifications are provided in the data.

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: PDF October 10, 2023 PICOPACK Inc. ℅ Mr. Edward Park CEO LightenBridge L, PICOPACK Inc. F350A WeSensor - RevMed, WESENSOR - wesnesor.framer.website, PICOPACK Inc. F150A WeSensor - RevMed

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Picopack, Inc.

Sources (1)

  • FDA 510(k) K230916 24 fields · synced Sep 20, 2026