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Pedra-1417mc, Pedra-1417mg, Pedra-1417fc, Pedra-1417fg

FDA 510(k)

Class II (US FDA 510(k))

510(k) K221144

by Radisen Co., Ltd.

Identifiers

510(k) Number
K221144 FDA 510(k)
FDA Product Code
MQB FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 892.1680 FDA 510(k)
Regulation Number
892.1680 FDA 510(k)
Advisory Committee
Radiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Pedra-1417MC, Pedra-1417MG, Pedra-1417FC, and Pedra-1417FG are Solid State X-Ray Imagers (Flat Panel/Digital Imagers). These devices employ amorphous silicon thin-film transistor (TFT) technology with scintillators (CsI or Gadox) to convert X-ray photons into electrical signals, enabling high-resolution digital radiography. They are designed for general radiography applications, providing clear and immediate imaging outputs. The integrated auto-trigger signal sensing allows for seamless operation without requiring direct generator integration, enhancing workflow efficiency.

These devices are supplied as reusable medical equipment, intended for use in radiology settings. They are classified under 21 CFR 892.1680 as Stationary X-Ray Systems and fall under Class II regulatory classification with product code MQB. The devices are not single-use and require proper maintenance, storage, and calibration to ensure accurate imaging performance. FDA clearance (510(k) K221144) confirms their compliance with regulatory standards for stationary X-ray imaging systems.

Frequently asked questions

What are the PEDRA-1417MC, MG, FC, and FG devices used for?

These are Solid State X-Ray Imagers designed for general radiography applications. They use amorphous silicon thin-film transistor technology with scintillators to convert X-ray photons into electrical signals, providing clear and immediate imaging outputs.

Are these devices single-use or reusable?

These devices are supplied as reusable medical equipment intended for use in radiology settings. They require proper maintenance, storage, and calibration to ensure accurate imaging performance throughout their lifespan.

What regulatory classification do these devices have?

The PEDRA-1417 series is classified under 21 CFR 892.1680 as Stationary X-Ray Systems and falls under Class II regulatory classification with product code MQB. They have received FDA clearance (510(k) K221144) for stationary X-ray imaging systems.

How are these devices supplied and what features enhance their operation?

These devices are supplied as reusable medical equipment for radiology settings. They feature integrated auto-trigger signal sensing that allows for seamless operation without requiring direct generator integration, enhancing workflow efficiency in clinical environments.

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: Pedra-1417mc, Pedra-1417mg, Pedra-1417fc, Pedra-1417fg (K221144) — Fda ..., PDF Radisen Co., Ltd. ℅ Mr. Dave Kim President Mtech Gro, K221144 - Pedra-1417mc, Pedra-1417mg, Pedra-1417fc, Pedr...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Radisen Co., Ltd.

Sources (1)

  • FDA 510(k) K221144 24 fields · synced Oct 6, 2026