ATLASPLAN

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K980584 ↗

FDA Product Code

HAW

Device Class

Class II

Regulation

21 CFR Part 882.4560

Advisory Committee

Neurology

FDA Decision

SESE Substantially Equivalent

• Radionics Disposable Rf Cannulae (Sc-C, Rfk-Db, Rfk-Ds)

  Class II

  FDA 510(k) K980430 Active Cleared 16 Mar 1998

• Rfg-3CF

  Class II

  FDA 510(k) K965182 Active Cleared 12 Mar 1997

• Radionics Microelectrode Kit

  Class II

  FDA 510(k) K991399 Active Cleared 21 Sep 1999

• Radionics Xdc External Ventricular Catheter

  Class II

  FDA 510(k) K992379 Active Cleared 8 Sep 1999

• Ocular-Biometer 4000

  Class II

  FDA 510(k) K820042 Active Cleared 22 Jul 1982

• Pace-1A Cardiac Stimulator

  Class II

  FDA 510(k) K963579 Active Cleared 8 Nov 1996

See all devices from Radionics, Inc. →

• What is ATLASPLAN used for?

  ATLASPLAN is a software system designed to guide neurosurgeons in planning functional procedures on the brain. It enables fine-tuning of target coordinates, determination of anatomical target boundaries, and planning of optimal surgical trajectories by translating and scaling images to match patient CT or MR datasets.

• How is ATLASPLAN supplied and what type of device is it?

  ATLASPLAN is supplied as a software system intended for use in neurosurgical planning environments. It is classified as a Class 2 Neurology device with product code HAW, meaning it is a digital tool that supports preoperative planning rather than a physical implant or instrument.

• What regulatory pathway was used for ATLASPLAN’s clearance?

  ATLASPLAN received FDA clearance through the Traditional 510(k) pathway under submission K980584. It was determined to be substantially equivalent to a predicate device and was cleared on May 18, 1998, based on its intended use and technological characteristics.