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DPS-33000 Nuclear Medicine Imaging Computer

by Adac Laboratories

510(k) K844784

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 NumberK844784 Date1 Feb 1985ClearedStatusActive

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  • Withdrawn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
LLZ
Device Class
Class II
Regulation
21 CFR Part 892.2050
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 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 DPS-33000 Nuclear Medicine Imaging Computer is a medical imaging system designed for processing and analyzing data from nuclear medicine studies. It falls under the classification of a radiological image processing system, facilitating the acquisition, reconstruction, and display of scintigraphic images for diagnostic evaluation in radiology settings.

This device is supplied as a standalone imaging computer system and is intended for use in radiology departments or nuclear medicine laboratories. It is classified as a Class II device under the FDA’s Special Controls for radiological systems and has received FDA 510(k) clearance (K844784) for substantial equivalence to a predicate device. The system is not described as single-use or reusable, nor is there mention of MRI compatibility or sterility requirements in the available data.

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