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PACS Plus 5TH Edition

by Medical Standard Co., Ltd.

510(k) K083658

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 NumberK083658 Date7 Jul 2009ClearedStatusActive

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  • Withdrawn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, 26 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

PACS Plus 5th Edition is a software-based Picture Archiving and Communication System (PACS). It ingests digital medical images and data from diverse sources, including CT, MR, ultrasound, R/F units, and radiographic devices. For non-DICOM sources, it utilizes a DICOM gateway or film digitizers to convert inputs into DICOM-compliant files. The system enables storage, network distribution, and retrieval of medical images.

The device is supplied as software and is intended for use in radiology settings. It received FDA 510(k) clearance (K083658) on July 7, 2009, and is substantially equivalent to a legally marketed predicate device. The product code is LLZ, and the advisory committee review was conducted by the Radiology panel.

Other devices from Medical Standard Co., Ltd.

  • Pacsplus

    Class II

  • Pacspartner

    Class II

Questions

AI-generated answers, 26 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 PACS Plus 5th Edition used for?

    The PACS Plus 5th Edition is a software-based Picture Archiving and Communication System designed to ingest digital medical images and data from diverse sources such as CT, MR, ultrasound, R/F units, and radiographic devices. It enables storage, network distribution, and retrieval of medical images in radiology settings by converting non-DICOM inputs into DICOM-compliant files using a DICOM gateway or film digitizers.

  • How is the PACS Plus 5th Edition supplied and deployed?

    The device is supplied as software and is intended for use in radiology settings. It requires installation on compatible hardware systems to function as a PACS, enabling the ingestion, storage, distribution, and retrieval of medical images from various imaging modalities after conversion to DICOM format via gateway or digitizer tools.

  • What regulatory clearance does the PACS Plus 5th Edition have?

    The PACS Plus 5th Edition received FDA 510(k) clearance under submission K083658 on July 7, 2009, and was determined to be substantially equivalent to a legally marketed predicate device. The product code is LLZ, and the review was conducted by the Radiology advisory committee.