XPLAN 2.1

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

510(k) Number

K001700 ↗

FDA Product Code

MUJ

Device Class

Class II

Regulation

21 CFR Part 892.5050

Advisory Committee

Radiology

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 the XPLAN 2.1 system used for?

  The XPLAN 2.1 is a Class II medical device used in radiology for planning radiation therapy treatment. It helps clinicians develop precise treatment plans for patients undergoing radiation therapy.

• Is the XPLAN 2.1 system sterile and single-use?

  No, the XPLAN 2.1 is supplied as a non-sterile, reusable system. It is designed for multiple uses in clinical settings, though proper cleaning and maintenance protocols should be followed between uses.

• What regulatory approvals does the XPLAN 2.1 have?

  The XPLAN 2.1 received FDA 510(k) clearance with K-number K001700 on June 28, 2000. It is regulated under product code MUJ with regulation number 892.5050. The device is not indicated for MRI use.

• Who manufactures the XPLAN 2.1 system?

  The XPLAN 2.1 is manufactured by Radionics, Inc., located in Burlington, MA. The company has been producing this radiation therapy planning system since it received FDA clearance in 2000.