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Extracranial Radiotherapy System

by Howmedica, Inc.

510(k) K982463

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 NumberK982463 Date30 Sep 1998ClearedStatusActive

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  • Withdrawn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.

This device is a Linear Accelerator, Medical, designed for delivering extracranial radiotherapy. It generates high-energy radiation beams to precisely target and treat extracranial lesions, tumors, or other pathological tissues under stereotactic guidance, ensuring accurate patient positioning and localization during both imaging and treatment phases.

The system is intended for use in radiology settings and has received FDA 510(k) clearance under the Traditional pathway, classified as Class II. It is not specified as single-use or reusable, nor are MRI safety details provided. The device operates under regulatory framework 892.5050 and is associated with the Radiology specialty. No sterility or storage conditions are explicitly stated in the available data.

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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 types of medical conditions is this device designed to treat?

    This Extracranial Radiotherapy System is specifically designed to deliver high-energy radiation beams for treating extracranial lesions, tumors, or pathological tissues. It uses stereotactic guidance to ensure precise targeting and accurate patient positioning during both imaging and treatment phases, which is critical for radiotherapy outside the cranial (head) region.

  • Is this device intended for single-use or can it be reused?

    The provided data does not specify whether this Extracranial Radiotherapy System is single-use or reusable. Reusability would depend on manufacturer guidelines, facility protocols, and regulatory compliance (e.g., sterilization validation). Clinicians should confirm with the manufacturer or facility policies before use.

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

    This device received FDA 510(k) clearance under the Traditional pathway, classified as Class II. The submission was filed under regulatory framework 892.5050 and reviewed by the Radiology (RA) Advisory Committee. The clearance was granted on September 30, 1998, following a determination of substantial equivalence (SESE) to a predicate device.

  • Where would this device typically be used in a healthcare setting?

    This Extracranial Radiotherapy System is intended for use in radiology departments within hospitals or specialized cancer centers. Its design supports precise extracranial radiotherapy, making it suitable for facilities equipped to handle advanced radiation oncology treatments, including stereotactic imaging and treatment planning.