IMPLANT SCIENCES CORP, MODEL HDR-4140— 510(k) K042864

Name: FDA 510(k) clearance K042864
Creator: U.S. Food and Drug Administration
Published: 2005-01-06

Substantially Equivalent

Implant Sciences Corp.

FDA 510(k) clearance K042864 for IMPLANT SCIENCES CORP, MODEL HDR-4140, Substantially Equivalent on 2005-01-06. Applicant: Implant Sciences Corp.. Device class: 2.

Clearance details

Applicant: Implant Sciences Corp.
Product code: Code KXK
Device class: Class 2
Regulation: 21 CFR 892.5730
Advisory panel: Radiology
Date received: 2004-10-18
Decision date: 2005-01-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wakefield, MA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KXK

view all

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 Implant Sciences Corp.

view all

K070468 — IMPLANT SCIENCES CORP. MODEL HDR 44542007-03-23
K023073 — SEED LINK2003-04-07
K023242 — I-PLANT MODEL 3500 (125IODINE BRACHYTHERAPY SEEDS)-STERILE2002-12-04
K994317 — I-PLANT, MODEL 35002000-03-21
K990193 — IODINE BRACHYTHERAPY SEEDS, MODEL 30001999-05-20

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