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Tomax Ultrascan

by Incubation Industries, Inc.

510(k) K892653

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 NumberK892653 Date28 Aug 1989ClearedStatusActive

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  • Withdrawn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
IZF
Device Class
Class II
Regulation
21 CFR Part 892.1740
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.

The Tomax Ultrascan is a System, X-Ray, Tomographic, used to generate x-ray images for diagnosis. It is a Class II mammography system manufactured by Incubation Industries, Inc.

The Tomax Ultrascan is supplied with FDA 510K authorizations and is used in radiology. It was cleared under K-number K892653 in 1989 and has a product code of IZF.

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 Tomax Ultrascan used for?

    The Tomax Ultrascan is used to generate x-ray images for diagnosis in radiology.

  • Is the Tomax Ultrascan a single-use device?

    The device data does not specify if the Tomax Ultrascan is single-use or reusable, but it is a system designed for repeated use in radiology settings.

  • What authorizations does the Tomax Ultrascan have?

    The Tomax Ultrascan has FDA 510K authorizations, cleared under K-number K892653 in 1989.