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Pixie

by Porta Ray, Inc.

510(k) K792665

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK792665 Date29 Jan 1980ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
IZL
Device Class
Class II
Regulation
21 CFR Part 892.1720
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Pixie is a mobile X-ray system used in radiology. It is a Class II device that received FDA 510(k) clearance under K-number K792665 on January 29, 1980.

Manufactured by Porta Ray, Inc., the Pixie is supplied as a mobile X-ray system for use in radiology settings. It is a reusable device with no stated sterility requirements, and its regulatory authorization is based on substantial equivalence to a predicate device.

Other devices from Porta Ray, Inc.

Questions

AI-generated answers, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Pixie mobile X-ray system intended for?

    The Pixie is a mobile X-ray system used in radiology settings, as stated in its description. It is designed for radiographic imaging in clinical environments where mobility is needed, such as hospitals or clinics, based on its classification as a mobile X-ray system under the Radiology medical specialty.

  • Is the Pixie device sterile or single-use?

    The Pixie is a reusable device with no stated sterility requirements, as explicitly mentioned in the device data. It is not supplied sterile and is intended for repeated use after appropriate cleaning and maintenance, consistent with its classification as a mobile X-ray system.

  • How was the Pixie device cleared for market entry?

    The Pixie received FDA 510(k) clearance under K-number K792665 on January 29, 1980, based on a determination of substantial equivalence to a predicate device. This traditional 510(k) pathway was used for its authorization, as indicated by the clearance_type and decision_code fields in the data.

  • What regulatory classification does the Pixie device have?

    The Pixie is classified as a Class II medical device, as specified in the openfda field where device_class=2. This classification aligns with its regulatory pathway under FDA 510(k) and its product code IZL for mobile X-ray systems in radiology.

  • Who manufactures the Pixie mobile X-ray system and where are they located?

    The Pixie is manufactured by Porta Ray, Inc., located at 803 N. Front St. Suite 3, McHenry, IL 60050, United States. This information is derived from the address_1, city, state, postal_code, and country_code fields in the device data.