Autocomp

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K911340 ↗

FDA Product Code

KPQ

Device Class

Class II

Regulation

21 CFR Part 892.5840

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

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See all devices from Victoreen, Inc. →

• What is the primary purpose of the Autocomp in a radiology setting?

  The Autocomp is designed to assist radiology teams in delivering precise radiation therapy by simulating treatment planning and performing dose calculations. This helps ensure accurate, patient-specific dose distributions, improving the reliability of radiation treatment delivery.

• Is the Autocomp intended for single-use or reusable applications?

  The Autocomp is supplied as a reusable system, meaning it is built for repeated use in clinical settings rather than disposable after a single application. This aligns with its classification as a Class II medical device under FDA guidelines.

• What regulatory pathway does the Autocomp follow, and where is it authorized for use?

  The Autocomp is authorized for use in the United States through FDA clearance via a 510(k) submission (K911340), classified as a Class II device. It adheres to FDA standards for radiation therapy simulation systems and is governed by regulatory requirements specific to radiology equipment.

• Does the Autocomp require sterilization before use, and if so, what are the guidelines?

  The Autocomp is not described as requiring sterility in its specifications, as it is a reusable system designed for use in controlled radiology environments rather than direct patient contact. However, standard infection control practices should still be followed during maintenance and cleaning.

• How is the Autocomp categorized in terms of medical specialty and device classification?

  The Autocomp is classified under Radiology as its medical specialty and falls under OpenFDA device classification 2 (Class II). It is specifically listed under the product code KPQ, which corresponds to radiation therapy simulation systems, ensuring it meets regulatory standards for that category.