← Product Code [JAQ](/submissions/RA/subpart-f%E2%80%94therapeutic-devices/JAQ) · K954467

# CADPLAN BT (K954467)

_Varian Assoc., Inc. · JAQ · Mar 15, 1996 · Radiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/JAQ/K954467

## Device Facts

- **Applicant:** Varian Assoc., Inc.
- **Product Code:** [JAQ](/submissions/RA/subpart-f%E2%80%94therapeutic-devices/JAQ.md)
- **Decision Date:** Mar 15, 1996
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 892.5700
- **Device Class:** Class 2
- **Review Panel:** Radiology
- **Attributes:** Therapeutic

## Indications for Use

CADPLAN BT is designed to allow the dose distribution of an applicator to be individually shaped for each patient.

## Device Story

CADPLAN BT is a Windows NT software application for brachytherapy treatment planning; operates in conjunction with VariSource High Dose Rate Remote Afterloader. Inputs include radiograph imaging (stereoshifted and orthogonal films) for applicator placement (up to 20 channels). Device calculates geometrically-optimal dwell times for catheters and shapes dose distribution per patient. Used by clinicians in oncology settings to facilitate radiation therapy planning. Output consists of optimized treatment plans and dwell time calculations, enabling precise radiation delivery to target tissues while sparing healthy anatomy.

## Clinical Evidence

No clinical data provided; bench testing only.

## Technological Characteristics

Windows NT software application. Supports stereoshifted and orthogonal film imaging. Utilizes linear source model for IR-192. Features automated dwell time calculation algorithm versus manual calculation in predicate. Calculates dose volume histograms.

## Regulatory Identification

A remote controlled radionuclide applicator system is an electromechanical or pneumatic device intended to enable an operator to apply, by remote control, a radionuclide source into the body or to the surface of the body for radiation therapy. This generic type of device may include patient and equipment supports, component parts, treatment planning computer programs, and accessories.

## Predicate Devices

- Varian VariSource Treatment Planning System ([K945383](/device/K945383.md))

## Submission Summary (Full Text)

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SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION
K954467

1. Submitter: Varian Oncology Systems
911 Hansen Way
Palo Alto, CA 94304
(415) 424-5036
Contact: Charles H. Will, Manager
Regulatory Compliance & Safety
Prepared: September 15, 1995
MAR 15 1996

2. Device Name: CADPLAN BT

3. Predicate Device: Varian VariSource Treatment Planning System
510(k) Notification 945383 (Varian VariSource High Dose Rate Remote Afterloader)
Cleared February 15, 1995

4. Device
CADPLAN BT is a Windows NT software application that is designed to work together with the VariSource High Dose Rate Remote Afterloader. It allows for applicator placement for up to 20 channels, and allows dose distribution of an applicator to be individually shaped for each patient. It also allows for calculation of the dwell time of the catheter.

5. Intended Use: CADPLAN BT is designed to allow the dose distribution of an applicator to be individually shaped for each patient.

6. Technological Characteristics
Both CADPLAN BT and VariSource Treatment Planning System have plan and multiple plan dose calculation, radiograph imaging definition that support's stereoshifted and orthogonal films and a linear source model for IR-192. Natural dose volume histogram can be calculated manually from normal dose volume histogram in both systems. CADPLAN BT calculates the geometrically-optimal dwell times through the software, whereas with the VariSource Treatment Planning System these dwell times must be calculated manually.

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**Source:** [https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/JAQ/K954467](https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/JAQ/K954467)

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