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Option U1 For The Dps-Plus System

by Adac Laboratories

510(k) K915305

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 NumberK915305 Date26 Feb 1992ClearedStatusActive

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  • Withdrawn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, 23 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 Option U1 is an image processing component designed for the Dps-Plus System. It functions as part of a radiological imaging configuration to support diagnostic image processing tasks.

This device is identified under the product code LLZ and received FDA 510(k) clearance on February 26, 1992, under reference number K915305. It is manufactured by Adac Laboratories.

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Questions

AI-generated answers, 23 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 Option U1?

    The Option U1 is an image processing component specifically engineered for the Dps-Plus System. It serves as an integrated part of a radiological imaging configuration to assist in diagnostic image processing tasks.

  • What is the regulatory status of this device?

    The Option U1 for the Dps-Plus System received FDA 510(k) clearance on February 26, 1992, under reference number K915305. This indicates the device was found to be substantially equivalent to a predicate device for its intended use.

  • Who is the manufacturer of the Option U1?

    The device is manufactured by Adac Laboratories, located in Milpitas, California. They are the official applicant associated with the K915305 regulatory filing.