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Image Fusion And Review System

by Adac Laboratories

510(k) K973233

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 NumberK973233 Date25 Nov 1997ClearedStatusActive

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  • Withdrawn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 Image Fusion and Review System is a medical device designed to register images geometrically in 3D and display sets of different medical image types, including MCD, SPECT, PET, CT, and MRI, as composite images. It enables operators to rotate, translate, and align images anatomically to match their geometric positions relative to one another.

This system is manufactured by Adac Laboratories and has received FDA 510(k) clearance. It is classified as a Class II system for emission computed tomography under product code KPS.

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