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North American Scientific I-125 Radionuclide Brachytherapy Source Model MED 3631-A

by Ml Strategies, Inc.

510(k) K972271

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 NumberK972271 Date28 Oct 1997ClearedStatusActive

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  • Withdrawn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)

Full name
North American Scientific (Nasi) I-125 Radionuclide Brachytherapy Source- Model Med 3631-A
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, 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.

The North American Scientific I-125 Radionuclide Brachytherapy Source Model MED 3631-A is a radionuclide-based brachytherapy device designed for interstitial, intracavity, or surface radiation therapy. It delivers localized radiation to treat malignant lesions through precise placement within or adjacent to target tissues.

This device is supplied as a single-use, sterile radionuclide source and is regulated under FDA 510(k) clearance (K972271) as a Class II medical device. It is intended for use in radiology settings and adheres to regulatory standards outlined in 21 CFR 892.5730. Handling requires adherence to radiation safety protocols due to its radioactive nature.

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