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Optisource, Model 1032P

by International Brachytherapy S.A.

510(k) K040766

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 NumberK040766 Date22 Jul 2004ClearedStatusActive

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  • Withdrawn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, 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 Optisource, Model 1032P is a brachytherapy radionuclide source device classified as a Class II medical device under regulation number 892.5730. It is substantially equivalent to a predicate device and was cleared via the traditional 510(k) pathway on July 22, 2004, with product code KXK.

The device is manufactured by International Brachytherapy S.A. and is used in radiology for interstitial implantation of select focalized tumors with low to moderate radiosensitivity. It is supplied as a single-use implant and is not MRI safe unless otherwise specified in labeling; storage and handling must follow manufacturer guidelines for radioactive sources.

Other devices from International Brachytherapy S.A.

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 Optisource Model 1032P used for?

    The Optisource Model 1032P is used in radiology for interstitial implantation of select focalized tumors with low to moderate radiosensitivity, delivering targeted radiation therapy directly to the tumor site.

  • Is the Optisource Model 1032P supplied as a single-use or reusable device?

    The Optisource Model 1032P is supplied as a single-use implant and is not intended for reuse; this ensures sterility, consistent radiation output, and compliance with radiation safety protocols for brachytherapy sources.

  • Is the Optisource Model 1032P MRI safe?

    The Optisource Model 1032P is not MRI safe unless otherwise specified in the labeling; users must consult the device’s specific labeling and follow manufacturer guidelines for handling and storage due to its radioactive nature.

  • How should the Optisource Model 1032P be stored and handled?

    Storage and handling of the Optisource Model 1032P must follow the manufacturer’s guidelines for radioactive sources, including appropriate shielding, access control, and inventory management to ensure radiation safety and regulatory compliance.