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PROWESS 2000

by Small Systems Group, Inc. 2 variants

510(k) K884261

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK884261 Date4 Aug 1989ClearedStatusActive

Recalls

0 recalls · FDA

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

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
KPQ
Device Class
Class II
Regulation
21 CFR Part 892.5840
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 26 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The PROWESS 2000 is a radiation therapy treatment planning system. It is designed to assist in the planning of radiation therapy treatments.

The PROWESS 2000 is supplied by Small Systems Group, Inc. and is a Class II medical device. It received FDA 510(k) clearance on August 4, 1989, with product code KPQ.

Other devices from Small Systems Group, Inc.

  • Prowess 2000

    Class II

Questions

AI-generated answers, 26 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the PROWESS 2000 used for?

    The PROWESS 2000 is a radiation therapy treatment planning system designed to assist healthcare professionals in planning radiation therapy treatments for patients.

  • How is the PROWESS 2000 supplied?

    The PROWESS 2000 is supplied by Small Systems Group, Inc. and is classified as a Class II medical device, indicating moderate risk to patients and users.

  • What is the regulatory status of the PROWESS 2000?

    The PROWESS 2000 received FDA 510(k) clearance on August 4, 1989, with product code KPQ, making it substantially equivalent to existing devices on the market.

  • Is the PROWESS 2000 a single-use or reusable device?

    The device data does not specify whether the PROWESS 2000 is designed for single-use or multiple uses, as this information is not included in the provided specifications.