← Back to catalogue

PIXX 1717 +3 more models

FDA 510(k)

Class II (US FDA 510(k))

510(k) K182533

by PixxGen Corporation

Identifiers

510(k) Number
K182533 FDA 510(k)
FDA Product Code
MQB FDA 510(k)
Models / Variants
PIXX 1717 FDA 510(k)
PIXX 1417 FDA 510(k)
PIXX 1212 FDA 510(k)
Digital Diagnostic X-ray Receptor Panels 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 PIXX 1717; PIXX 1417; PIXX 1212; Digital Diagnostic X-ray Receptor Panels are solid state x-ray imagers (flat panel/digital imagers) intended for use in general radiographic images of human anatomy. They are designed to replace radiographic film/screen systems in all general-purpose diagnostic procedures, excluding fluoroscopic, angiographic, and mammographic applications.

These devices are supplied as digital diagnostic x-ray receptor panels and are intended for single-use in clinical settings. They are regulated under FDA 510(k) clearance with product code MQB and regulation number 892.1680. The device is classified as Class II and is not indicated for MRI safety. Storage conditions are not specified in the provided data.

Frequently asked questions

What are the PIXX Digital Diagnostic X-ray Receptor Panels used for?

These solid state x-ray imagers are designed for general radiographic images of human anatomy, replacing radiographic film/screen systems in all general-purpose diagnostic procedures. They are not intended for fluoroscopic, angiographic, or mammographic applications.

Are these receptor panels single-use or reusable?

The PIXX Digital Diagnostic X-ray Receptor Panels are intended for single-use in clinical settings. This means they should be used once and then disposed of appropriately according to medical waste protocols.

What regulatory status do these devices have?

These devices are regulated under FDA 510(k) clearance with product code MQB and regulation number 892.1680. They are classified as Class II medical devices, which means they require special controls to ensure their safety and effectiveness.

What models are available in the PIXX Digital Diagnostic X-ray Receptor Panel series?

The PIXX Digital Diagnostic X-ray Receptor Panel series includes three models: PIXX 1717, PIXX 1417, and PIXX 1212. Each model offers different specifications to accommodate various clinical imaging needs while maintaining the same core functionality as solid state x-ray imagers.

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: PIXX 1717; PIXX 1417; PIXX 1212; Digital Diagnostic X-ray Receptor Panels, PDF 510(k) premarket notification, PIXX 1717; PIXX 1417; PIXX 1212; Digital Diagnostic X-ray Receptor Panels, PIXX 1717; PIXX 1417; PIXX 1212; Digital Diagnostic X-ray Receptor ...

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
PixxGen Corporation

Sources (1)

  • FDA 510(k) K182533 24 fields · synced Oct 6, 2026