T.O.P. 2000 (Tomographic Orientated Planning)

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

510(k) Number

K870221 ↗

FDA Product Code

KPQ

Device Class

Class II

Regulation

21 CFR Part 892.5840

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

• Kermath Radiographic Head Stand

  Class II

  FDA 510(k) K811215 Active Cleared 12 Jun 1981

• Versatome

  Class II

  FDA 510(k) K771549 Active Cleared 25 Aug 1977

• Kermath L/C Arm

  Class II

  FDA 510(k) K812332 Active Cleared 16 Sep 1981

• Kermath Therapy Simulator

  Class II

  FDA 510(k) K812726 Active Cleared 5 Nov 1981

• What is the T.O.P. 2000 system used for?

  The T.O.P. 2000 is a tomographic orientated planning system designed for radiation therapy simulation. It assists in planning radiation therapy treatments by providing tomographic imaging capabilities in radiology settings.

• How is the T.O.P. 2000 supplied and what is its regulatory status?

  The T.O.P. 2000 is supplied as part of a radiation therapy planning system. It is a Class 2 medical device with FDA 510(k) clearance (K870221) received on May 12, 1987, and is regulated under product code KPQ.

• Is the T.O.P. 2000 a single-use device or can it be reused?

  The device data does not specify whether the T.O.P. 2000 is designed for single-use or multiple reuse. This information would need to be obtained from the manufacturer's documentation or product specifications.

• What sizes and models of the T.O.P. 2000 are available?

  The device data only mentions the T.O.P. 2000 model without specifying different sizes or variants. Additional information regarding available sizes or models would need to be obtained from the manufacturer directly.

• What are the storage requirements for the T.O.P. 2000 system?

  The device data does not specify storage requirements for the T.O.P. 2000 system. Storage conditions would typically be detailed in the manufacturer's instructions for use, which should be consulted for proper handling and storage guidelines.