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Prism 3000 Nuclear Gamma Camera System Modification

by Ohio Imaging, Inc.

510(k) K934722

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 NumberK934722 Date13 May 1994ClearedStatusActive

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  • Withdrawn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, 22 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 Prism 3000 Nuclear Gamma Camera System Modification is an emission computed tomography system. It is designed for use in radiology to perform diagnostic imaging procedures.

This device is manufactured by Ohio Imaging, Inc. and has received FDA 510(k) clearance under the regulation number 892.1200.

Other devices from Ohio Imaging, Inc.

Questions

AI-generated answers, 22 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 primary function of the Prism 3000 system?

    The Prism 3000 Nuclear Gamma Camera System Modification is an emission computed tomography system designed specifically for use in radiology to perform diagnostic imaging procedures.

  • Has this device received regulatory clearance?

    Yes, this device has received FDA 510(k) clearance under the regulation number 892.1200. This indicates that the system has been reviewed and found to be substantially equivalent to legally marketed predicate devices.

  • Who is the manufacturer of this imaging system?

    The Prism 3000 Nuclear Gamma Camera System Modification is manufactured by Ohio Imaging, Inc., based in Cleveland, Ohio.