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IR-192 IMPLANT

by Rads S.L., Inc. 3 variants

510(k) K874895

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK874895 Date25 Feb 1988ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 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  • Withdrawn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
IWA
Device Class
Class II
Regulation
21 CFR Part 892.5730
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 6 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 IR-192 IMPLANT is a Class II medical device classified as a Source, Wire, Iridium, Radioactive device used in radiology. It is manufactured by Rads S.L., Inc. and is designed for medical applications in healthcare.

The device is supplied as an implant and is used for curative purposes, primarily in the breast and head regions. It is manufactured in wire form and is introduced into the treatment area. The device has FDA 510(k) clearance with K numbers K874895 and K844248, with the most recent clearance on February 25, 1988.

Other devices from Rads S.L., Inc.

  • Ir-192 Implant

    Class II

  • Ir-192 Implant

    Class II

Questions

AI-generated answers, 6 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 IR-192 IMPLANT used for?

    The IR-192 IMPLANT is a Class II medical device designed for curative purposes, primarily used in the treatment of breast and head regions. It is a radioactive wire implant introduced into the treatment area for radiology applications.

  • How is the IR-192 IMPLANT supplied?

    The device is supplied as an implant in wire form, manufactured by Rads S.L., Inc. It is designed to be introduced into the treatment area for medical applications in healthcare settings.

  • What is the regulatory status of the IR-192 IMPLANT?

    The IR-192 IMPLANT has FDA 510(k) clearance with K numbers K874895 and K844248, with the most recent clearance granted on February 25, 1988. It is classified as a Class II medical device under product code IWA.

  • Is the IR-192 IMPLANT single-use or reusable?

    The device description does not specify whether the IR-192 IMPLANT is single-use or reusable. As a radioactive implant, its usage would depend on the specific clinical protocol and radiation safety guidelines.