Skip to content

Hercules Radiation Therapy Couch

by Precision Therapy Intl., Inc.

510(k) K950061

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 NumberK950061 Date16 Aug 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  • Withdrawn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, 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 Hercules Radiation Therapy Couch is a Radiation Therapy Table designed for precise patient positioning during external beam radiotherapy. It supports immobilization and alignment of patients in linear accelerator treatment rooms, ensuring accurate delivery of radiation doses to targeted treatment areas while minimizing exposure to surrounding tissues.

This device is intended for use in radiology departments and is supplied as a reusable medical equipment component. It is classified as a Class II device under FDA regulation 892.5050 and was granted FDA 510(k) clearance (K950061) in 1995. The couch is engineered for compatibility with linear accelerators and adheres to MRI safety standards where applicable. No specific sterility or single-use requirements are noted in the regulatory filings.

Other devices from Precision Therapy Intl., 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 Hercules Radiation Therapy Couch primarily used for in a clinical setting?

    The Hercules Radiation Therapy Couch is designed for precise patient positioning during external beam radiotherapy. It ensures accurate alignment and immobilization of patients in linear accelerator treatment rooms, which helps deliver targeted radiation doses to treatment areas while minimizing exposure to surrounding healthy tissues.

  • Is the Hercules Radiation Therapy Couch intended for single-use or reusable applications?

    The Hercules Radiation Therapy Couch is supplied as reusable medical equipment. There are no regulatory filings indicating it requires single-use or sterility measures, so it is intended for repeated use in clinical settings.

  • What regulatory pathway was followed for the FDA clearance of this device?

    The Hercules Radiation Therapy Couch received FDA 510(k) clearance under the traditional review pathway, with the clearance number K950061. It was classified as a Class II device under FDA regulation 892.5050 and was determined to be substantially equivalent to a predicate device in the radiology specialty.

  • Does this device have compatibility with MRI environments?

    Yes, the Hercules Radiation Therapy Couch is engineered to adhere to MRI safety standards where applicable, ensuring it can be used in environments where MRI compatibility is required.

  • What types of facilities would typically use this device?

    This device is intended for use in radiology departments, specifically in linear accelerator treatment rooms where external beam radiotherapy is administered. It is designed to support precise patient positioning for accurate radiation delivery.