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Planet Thermoplastic Immobilization System

by S & S X-Ray Products, Inc.

510(k) K944040

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 NumberK944040 Date21 Jul 1995ClearedStatusActive

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  • Withdrawn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
IYE
Device Class
Class II
Regulation
21 CFR Part 892.5050
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 27 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 Planet Thermoplastic Immobilization System is a medical device used in radiology for patient immobilization during imaging procedures. It is designed to securely hold patients in a fixed position to ensure accurate and repeatable imaging results.

The device is supplied as a reusable system and is intended for use in clinical radiology settings. It has received FDA 510(k) clearance (K944040) and is classified as a Class II device under regulation number 892.5050, with product code IYE and medical specialty in radiology.

Other devices from S & S X-Ray Products, Inc.

Questions

AI-generated answers, 27 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 Planet Thermoplastic Immobilization System used for?

    The Planet Thermoplastic Immobilization System is used in radiology to securely hold patients in a fixed position during imaging procedures, ensuring accurate and repeatable imaging results by preventing movement that could distort images.

  • Is the Planet Thermoplastic Immobilization System reusable or single-use?

    The device is supplied as a reusable system, meaning it is designed for multiple uses after proper cleaning and disinfection between patients, making it suitable for ongoing clinical radiology settings where repeated use is required.

  • What regulatory clearance does the Planet Thermoplastic Immobilization System have?

    The Planet Thermoplastic Immobilization System has received FDA 510(k) clearance under submission number K944040, which confirms it is substantially equivalent to a legally marketed predicate device and is classified as a Class II medical device under regulation 892.5050.

  • What is the product code and medical specialty for the Planet Thermoplastic Immobilization System?

    The device is assigned product code IYE and is classified under the medical specialty of radiology, as indicated in its FDA 510(k) documentation, reflecting its intended use in diagnostic imaging procedures to immobilize patients.