BRACHYSEED PD-103 MODELS #PD1— 510(k) K011119

Substantially Equivalent

Draximage, Inc.

FDA 510(k) clearance K011119 for BRACHYSEED PD-103 MODELS #PD1, Substantially Equivalent on 2001-06-25. Applicant: Draximage, Inc.. Device class: 2.

Clearance details

Applicant: Draximage, Inc.
Product code: Code KXK
Device class: Class 2
Regulation: 21 CFR 892.5730
Advisory panel: Radiology
Date received: 2001-04-12
Decision date: 2001-06-25
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Kirkland, Qc, CA

Download summary PDF View on FDA.gov ↗

Recent devices under product code KXK

K252296 — OncoPatch2025-12-05
K242818 — IsoSphere2025-07-15
K223465 — RadianceTx Radionuclide Brachytherapy Source2023-01-11
K221539 — GammaTile2022-11-09
K202267 — Sirius MRI Markers, Cs-131 Preloaded Strands with Sirius MRI Markers in 18 Gauge Needles2020-12-31

More clearances from Draximage, Inc.

K000475 — BRACHYSEED2000-08-22

Data sourced from openFDA. This site is unofficial and independent of the FDA.