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Precise Treatment System - Infinity

by Eleckta Limited

510(k) K182138

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 NumberK182138 Date5 Sep 2018ClearedStatusActive

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  • Withdrawn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
Models / Variants
Infinity
Device Class
Class II
Regulation
21 CFR Part 892.5050
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 21 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 Precise Treatment System; Synergy platform; Synergy; Infinity; VersaHD is a medical linear accelerator. It is indicated to assist a licensed practitioner in the delivery of radiation to defined target volumes such as lesions, arterio-venous malformations, malignant and benign tumors, while sparing surrounding normal tissue and critical organs from excess radiation.

This device is supplied by Eleckta Limited and has received FDA 510(k) clearance under K-number K182138. It is classified as a Class II medical device under regulation number 892.5050 and is used in radiation therapy settings for cancer treatment.

Questions

AI-generated answers, 21 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 Precise Treatment System Synergy platform used for?

    It is indicated to assist a licensed practitioner in delivering radiation to defined target volumes such as lesions, arterio-venous malformations, malignant and benign tumors, while sparing surrounding normal tissue and critical organs from excess radiation.

  • How is the Precise Treatment System Synergy platform supplied and by whom?

    This device is supplied by Eleckta Limited, the manufacturer, and is distributed as a medical linear accelerator for use in radiation therapy settings.

  • What regulatory clearance does the Precise Treatment System Synergy platform have?

    It has received FDA 510(k) clearance under K-number K182138 and is classified as a Class II medical device under regulation number 892.5050.