Skip to content

Prowess 2000

by Small Systems Group, Inc. 2 variants

510(k) K924240

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK924240 Date17 May 1993ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 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  • Withdrawn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
IYE
Device Class
Class II
Regulation
21 CFR Part 892.5050
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 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 linear accelerator, a medical device used for high-energy radiation therapy in oncology. It delivers precise, controlled radiation doses to treat malignant tumors by accelerating electrons to generate X-rays or electron beams for targeted cancer treatment.

This device is designed for use in radiology departments and radiation oncology clinics, where it operates as a reusable, non-sterile medical instrument. The Prowess 2000 holds an FDA 510(k) clearance under product code IYE, with a regulatory classification as Class II. It is intended for professional healthcare settings and adheres to regulatory standards outlined in 21 CFR 892.5050.

Other devices from Small Systems Group, Inc.

  • Prowess 2000

    Class II