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C-Equal (Ceders-Emory Quantitive Analysis)

by Adac Laboratories

510(k) K932745

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 NumberK932745 Date5 Aug 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  • Withdrawn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
KPS
Device Class
Class II
Regulation
21 CFR Part 892.1200
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 27 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 C-Equal (Ceders-Emory Quantitive Analysis) is a System, Tomography, Computed, Emission, used in radiology. It is a Class II PET scanner manufactured by Adac Laboratories.

The device is supplied with a product code of KPS and a regulation number of 892.1200. It has been cleared under K-number K932745 in 1993, with an FDA 510K authorization. The device is used in radiology settings.

Other devices from Adac Laboratories

See all devices from Adac Laboratories →

Questions

AI-generated answers, 27 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 C-Equal used for?

    The C-Equal is used in radiology settings for computed emission tomography.

  • What is the regulatory status of the C-Equal?

    The C-Equal has been cleared under FDA 510K authorization, with a K-number of K932745.

  • What product code does the C-Equal have?

    The C-Equal has a product code of KPS and a regulation number of 892.1200.