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INTERSOURCE

by International Brachytherapy S.A.

510(k) K973328

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 NumberK973328 Date10 Dec 1998ClearedStatusActive

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  • Withdrawn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
KXK
Device Class
Class II
Regulation
21 CFR Part 892.5730
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

INTERSOURCE is a Class II medical device classified as a source for brachytherapy, a radiation therapy technique. It is intended for use in radiology procedures to deliver targeted radiation treatment.

The device is supplied sterile and is intended for single use. It is not reusable and must be disposed of after use. INTERSOURCE is not MRI safe and requires specific storage conditions to maintain sterility. The device has received FDA 510(k) clearance under K-number K973328.

Other devices from International Brachytherapy S.A.

Questions

AI-generated answers, 1 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 INTERSOURCE device used for?

    INTERSOURCE is a source for brachytherapy, a radiation therapy technique used in radiology procedures to deliver targeted radiation treatment.

  • Is INTERSOURCE intended for single use?

    Yes, INTERSOURCE is supplied sterile and is intended for single use. It is not reusable and must be disposed of after use.

  • Is INTERSOURCE safe for use in an MRI environment?

    No, INTERSOURCE is not MRI safe and requires specific storage conditions to maintain sterility.

  • What is the regulatory status of INTERSOURCE?

    INTERSOURCE has received FDA 510(k) clearance under K-number K973328.