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Auto-Mate Camera

by Aptek, Ltd.

510(k) K803157

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 NumberK803157 Date2 Feb 1981ClearedStatusActive

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  • Withdrawn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
IYO
FDA applicant
Aptek , Ltd.
Device Class
Class II
Regulation
21 CFR Part 892.1560
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 24 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 Auto-Mate Camera is a Class II ultrasound system. It is used in radiology.

The device received FDA 510(k) clearance under K-number K803157 in 1981. It was found substantially equivalent to a predicate device. The manufacturer is Aptek, Ltd.

Other devices from Aptek, Ltd.

Questions

AI-generated answers, 24 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 Auto-Mate Camera used for?

    The Auto-Mate Camera is a Class II ultrasound system used in radiology for imaging purposes, as indicated in its device description and intended use within radiological applications.

  • How was the Auto-Mate Camera cleared for market?

    The device received FDA 510(k) clearance under K-number K803157 in 1981 after being found substantially equivalent to a predicate device through a traditional review pathway.

  • Who manufactures the Auto-Mate Camera and where are they located?

    The Auto-Mate Camera is manufactured by Aptek, Ltd., located at 803 N. Front St. Suite 3, McHenry, IL 60050, United States, as listed in the device’s authorization and address details.