CADPLAN BT

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

510(k) Number

K954467 ↗

FDA Product Code

JAQ

Device Class

Class II

Regulation

21 CFR Part 892.5700

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

• Bds-3 Beam Data Scanner

  Class I

  FDA 510(k) K844620 Active Cleared 1 Jul 1985

• Flouroscope, Mobile C-Arm Image Intens.

  Class II

  FDA 510(k) K760429 Active Cleared 23 Aug 1976

• Spectrophotometer Analysis Sys.

  Class I

  FDA 510(k) K771807 Active Cleared 28 Nov 1977

• Applicators for Varian Varisource Remote High Dose Rate Afterloader

  Class II

  FDA 510(k) K955844 Active Cleared 26 Jul 1996

• Spectrophotometer Analysis Sys., Aa-175

  Class I

  FDA 510(k) K770443 Active Cleared 8 Apr 1977

• Electron Beam Option for Clinac 15 Mev

  Class II

  FDA 510(k) K832502 Active Cleared 12 Sep 1983

See all devices from Varian Assoc., Inc. →

• What is the primary purpose of the CADPLAN BT software in a clinical setting?

  The CADPLAN BT is designed to assist in high-dose-rate brachytherapy treatment planning for cancer patients. It provides computational tools for precise dose calculations and radiation therapy delivery, ensuring accurate targeting of tumors while minimizing exposure to surrounding healthy tissue. This software is specifically intended for use with compatible remote afterloader systems in radiology departments.

• Is the CADPLAN BT software single-use or reusable, and what does that mean for my facility?

  The CADPLAN BT is a reusable software solution, meaning it can be installed and used repeatedly across multiple patients and procedures. Since it is non-sterile and does not require disposal after each use, your facility can maintain a single installation for ongoing brachytherapy planning without the need for frequent replacements or additional licensing.

• What system compatibility or hardware requirements should I consider before purchasing the CADPLAN BT?

  The CADPLAN BT is a standalone Windows NT-based application, so it requires a compatible Windows NT operating system to run. It is designed for use with remote afterloader systems—meaning it must be paired with a compatible high-dose-rate brachytherapy delivery system. Since it is software-only, no additional hardware (like applicators or radionuclides) is included, but your facility must ensure the hardware infrastructure aligns with the software’s intended use.

• How is the CADPLAN BT regulated, and what does that mean for my facility’s compliance?

  The CADPLAN BT was cleared by the FDA under a 510(k) submission (K954467) in 1996 and is classified as a Class II medical device under regulation 892.5700. This means it has undergone FDA review for safety and effectiveness in its intended use for high-dose-rate brachytherapy treatment planning. Your facility must ensure the software is used as intended (with compatible remote afterloaders) and maintain proper records, but no additional licensing or certification is required beyond standard IT compliance for medical software.

• Does the CADPLAN BT have any special storage or handling requirements?

  Since the CADPLAN BT is a software-only solution, it does not require physical storage like consumable devices. However, it must be installed on a secure, compliant Windows NT system with proper IT safeguards to prevent unauthorized access or modifications. No sterility or environmental controls apply, as it is non-sterile and does not degrade with typical office or clinical use. Regular software updates may be recommended by the manufacturer to ensure continued functionality and compliance.