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Scandiplan Version 338

by Scanditronix, Inc.

510(k) K914926

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 5 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 5 Oct 2026. What this means

Regulatory status

as of registry sync 5 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK914926 Date28 May 1992ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 5 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  • Withdrawn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
KPQ
Device Class
Class II
Regulation
21 CFR Part 892.5840
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

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

The Scandiplan Version 338 is a Simulation System for Radiation Therapy, designed to assist in the planning and simulation of radiation treatment. It falls under the Radiology medical specialty and is classified as a Class II device. This system aids clinicians in visualizing and planning radiation dose distributions for precise patient treatment, supporting accurate alignment and positioning in radiotherapy workflows.

This device is supplied as a reusable system and is intended for use in radiology departments within healthcare facilities. It is not sterile and requires appropriate cleaning and maintenance between uses. The Scandiplan Version 338 has received FDA 510(k) clearance under the product code KPQ, with its regulatory submission filed under the Radiology (RA) Advisory Committee. No specific MRI safety classification is noted in the available data.

Other devices from Scanditronix, Inc.

Questions

AI-generated answers, 1 Oct 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 Scandiplan Version 338 used for?

    The Scandiplan Version 338 is a Simulation System for Radiation Therapy designed to assist clinicians in planning and simulating radiation treatment. It helps visualize radiation dose distributions and ensures accurate patient alignment and positioning, improving precision in radiotherapy workflows.

  • Is the Scandiplan Version 338 a single-use or reusable device?

    The Scandiplan Version 338 is a reusable system. It is intended for use in radiology departments and requires proper cleaning and maintenance between uses to ensure functionality and safety.

  • What regulatory clearance does the Scandiplan Version 338 have?

    The Scandiplan Version 338 has received FDA 510(k) clearance under product code KPQ. The device was determined to be substantially equivalent to a legally marketed predicate and was reviewed by the Radiology (RA) Advisory Committee.

  • Does the Scandiplan Version 338 come sterile?

    No, the Scandiplan Version 338 is not sterile. It is designed for reusable use in radiology departments, so appropriate cleaning and maintenance procedures must be followed between patient applications.

  • What medical specialty is the Scandiplan Version 338 intended for?

    The Scandiplan Version 338 is classified under the Radiology medical specialty. It supports the planning and simulation of radiation therapy, which is a core component of radiology workflows.