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Vacudap, Model 2000, 2001

by Victoreen, Inc.

510(k) K974112

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 NumberK974112 Date29 Jan 1998ClearedStatusActive

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  • Withdrawn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
KPR
Device Class
Class II
Regulation
21 CFR Part 892.1680
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 21 Sep 2026

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

This device is a stationary X-ray system, as defined by its device type and nomenclature. It is a radiology system designed for stationary use in medical imaging environments.

The device was cleared via the FDA 510(k) process under K974112 with a traditional clearance and is classified as a Class II medical device. It is manufactured by Victoreen, Inc. and is intended for use in radiology settings, with no claims made regarding sterility, single-use status, MRI safety, or storage conditions beyond what is explicitly stated in the data.

Other devices from Victoreen, Inc.

See all devices from Victoreen, Inc. →

Questions

AI-generated answers, 21 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 VACUDAP Model 2000 2001 used for?

    The VACUDAP Model 2000 and 2001 is a stationary X-ray system designed for use in medical imaging environments, specifically in radiology settings, as defined by its device type and nomenclature.

  • How was the VACUDAP Model 2000 2001 cleared for market?

    The device was cleared via the FDA 510(k) process under submission K974112 with a traditional clearance, determined to be substantially equivalent to a predicate device, and classified as a Class II medical device.

  • Who manufactures the VACUDAP Model 2000 2001 and where is it located?

    The VACUDAP Model 2000 and 2001 is manufactured by Victoreen, Inc., located at 6000 Cochran Rd., Solon, OH 44139, United States.