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Amicas Vision Series Pacs, Model 5.5

by Amicas, Inc.

510(k) K073526

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 NumberK073526 Date12 Mar 2008ClearedStatusActive

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  • Withdrawn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, 21 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 Amicas Vision Series Pacs, Model 5.5 is a software-only system intended to create and display two-dimensional and three-dimensional images of anatomy from a series of digitally acquired images. It offers real-time status of radiology activity and provides customizable workflow management capabilities.

The device is supplied as a software system and is used in radiology. It has been authorized with an FDA 510K clearance. The system includes components such as the Amicas Real Time Worklist, which facilitates communication of critical results and provides customizable workflow management capabilities.

Other devices from Amicas, Inc.

Questions

AI-generated answers, 21 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 Amicas Vision Series PACS Model 5.5 used for?

    The Amicas Vision Series PACS Model 5.5 is used to create and display two-dimensional and three-dimensional images of anatomy from digitally acquired images in radiology.

  • How is the Amicas Vision Series PACS Model 5.5 supplied?

    The device is supplied as a software system.

  • What regulatory authorization has the Amicas Vision Series PACS Model 5.5 received?

    The Amicas Vision Series PACS Model 5.5 has been authorized with an FDA 510K clearance, indicating it is substantially equivalent to a predicate device.