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DPS-3300 Micro Nuclear Medicine Imaging Computer

by Adac Laboratories

510(k) K844783

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 NumberK844783 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  • Withdrawn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, 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 DPS-3300 Micro Nuclear Medicine Imaging Computer is a system for image processing in radiology, classified under the LLZ product code as a radiological image processing system. It is designed for advanced image processing and PACS-adjacent functions in nuclear medicine imaging.

The device was cleared by the FDA through the traditional 510(k) pathway under K-number K844783 on February 1, 1985, and is classified as a Class II device requiring special controls. It is manufactured by Adac Laboratories and supplied as a non-sterile, reusable system for use in radiology settings.

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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 DPS-3300 Micro Nuclear Medicine Imaging Computer used for?

    The DPS-3300 is designed for advanced image processing and PACS-adjacent functions in nuclear medicine imaging, serving as a radiological image processing system under product code LLZ to support diagnostic workflows in radiology departments.

  • Is the DPS-3300 Micro Nuclear Medicine Imaging Computer sterile or non-sterile, and is it intended for single-use or reuse?

    The DPS-3300 is supplied as a non-sterile, reusable system, meaning it is not provided in a sterile condition and is designed for repeated use in radiology settings after appropriate cleaning and maintenance between uses.

  • How was the DPS-3300 Micro Nuclear Medicine Imaging Computer cleared for market, and what is its regulatory classification?

    The device was cleared by the FDA through the traditional 510(k) pathway under K-number K844783 on February 1, 1985, and is classified as a Class II device requiring special controls, based on its substantial equivalence to a legally marketed predicate device.