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PowerServer, PowerReader, Gateway and PowerCache

by Ramsoft Inc

510(k) K052460

Active European Union and United States

CE MDD 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K052460↗

FDA record

Trust

Unverified

Source EUDAMED, FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK052460 Date21 Sep 2005ClearedStatusActive
European UnionCE/MDD EUDAMED Number— Date—StatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K052460 decided 21 Sep 2005 Active
  • EUDAMED Active

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

510(k) Number
FDA product code
LLZ
FDA applicant
Ramsoft, Inc.
Device class
Class II
Regulation
21 CFR Part 892.2050
Advisory committee
Radiology
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 18 Sep 2026

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

This device is a Radiology Information System Workstation (Product Code: LLZ) designed to manage, process, and display digital medical imaging data. It integrates with Picture Archiving and Communication Systems (PACS) to enable radiologists and clinicians to view, store, and retrieve diagnostic images efficiently, supporting workflows in radiology departments.

The system is supplied as a software-hardware combination, intended for use in radiology settings where digital imaging is processed. It is not described as single-use or reusable, and no sterility or MRI safety information is provided. Authorisations include FDA 510K clearance under the Traditional pathway and MDD compliance, with no explicit details on sterility, single-use, or regulatory status beyond the stated approvals.

Devices cleared under K052460

53 devices · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K052460
UDI-DISize and differences
RamSoft 6.0.10.10100
Ramsoft Inc
6.0.10.10100B359PSPACS6PRU100
Single use: no
On the market
RamSoft 6.0.10.10100
Ramsoft Inc
6.0.10.10100B359GWR6PRU100
Single use: no
On the market
RamSoft 6.0.10.10100
Ramsoft Inc
6.0.10.10100B359PSRISPACS6PRU100
Single use: no
On the market
RamSoft 6.0.10.10100
Ramsoft Inc
6.0.10.10100B359GWY6PRU100
Single use: yes
On the market
RamSoft 6.0.11.11031
Ramsoft Inc
6.0.11.11031B359PSGWR6PRU110
Single use: no
On the market
RamSoft 6.0.11.11031
Ramsoft Inc
6.0.11.11031B359PSGWY6PRU110
Single use: no
On the market
RamSoft 6.0.11.11031
Ramsoft Inc
6.0.11.11031B359PSPACS6PRU110
Single use: no
On the market
RamSoft 6.0.11.11031
Ramsoft Inc
6.0.11.11031B359PSRISPACS6PRU110
Single use: no
On the market
RamSoft 6.0.11.11031A
Ramsoft Inc
6.0.11.11031AB359PSGWY6PRU11A0
Single use: no
On the market
RamSoft 6.0.11.11031A
Ramsoft Inc
PSPACS6 / 6.0.11.11031AB359PSPACS0
Single use: no
On the market
RamSoft 6.0.11.11031A
Ramsoft Inc
PSRISPACS6 / 6.0.11.11031AB359PSRISPACS0
Single use: no
On the market
RamSoft 6.0.11.11031B
Ramsoft Inc
PSGWY6PRU11B / 6.0.11.11031BB359PSGWY6PRU11B0
Single use: no
On the market
RamSoft 6.0.11.11031B
Ramsoft Inc
PSPACS6PRU11B / 6.0.11.11031BB359PSPACS6PRU11B0
Single use: no
On the market
RamSoft 6.0.11.11031B
Ramsoft Inc
PSRISPACS6PRU11B / 6.0.11.11031BB359PSRISPACS6PRU11B0
Single use: no
On the market
RamSoft 6.0.5.5040
Ramsoft Inc
GWR6 / 6.0.5.5040B359GWR60
Single use: no
On the market
RamSoft 6.0.5.5040
Ramsoft Inc
GWY6 / 6.0.5.5040B359GWY60
Single use: no
On the market
RamSoft 6.0.5.5040
Ramsoft Inc
PSPACS6 / 6.0.5.5040B359PSPACS60
Single use: no
On the market
RamSoft 6.0.5.5100
Ramsoft Inc
6.0.5.5100B359GWY6PRU510
Single use: no
On the market
RamSoft 6.0.5.5100
Ramsoft Inc
6.0.5.5100B359GWR6PRU510
Single use: yes
On the market
RamSoft 6.0.5.5100
Ramsoft Inc
6.0.5.5100B359PSRISPACS6PRU510
Single use: no
On the market
RamSoft 6.0.6.6015
Ramsoft Inc
6.0.6.6015B359GWY6PRU60
Single use: no
On the market
RamSoft 6.0.6.6015
Ramsoft Inc
6.0.6.6015B359PSRISPACS6PRU60
Single use: no
On the market
RamSoft 6.0.6.6015
Ramsoft Inc
6.0.6.6015B359GWR6PRU60
Single use: no
On the market
RamSoft 6.0.6.6015
Ramsoft Inc
6.0.6.6015B359PSPACS6PRU60
Single use: no
On the market
RamSoft 6.0.7.7115
Ramsoft Inc
6.0.7.7115B359GWR6PRU70
Single use: no
On the market
RamSoft 6.0.7.7115
Ramsoft Inc
GWY6PRU7 / 6.0.7.7115B359GWY6PRU70
Single use: no
On the market
RamSoft 6.0.7.7115
Ramsoft Inc
PSPACS6PRU7 / 6.0.7.7115B359PSPACS6PRU70
Single use: no
On the market
RamSoft 6.0.7.7115
Ramsoft Inc
PSRISPACS6PRU7 / 6.0.7.7115B359PSRISPACS6PRU70
Single use: yes
On the market
RamSoft 6.0.7.7221
Ramsoft Inc
6.0.7.7221B359GWR6PRU720
Single use: no
On the market
RamSoft 6.0.7.7221
Ramsoft Inc
6.0.7.7221B359GWY6PRU720
Single use: no
On the market
RamSoft 6.0.7.7221
Ramsoft Inc
6.0.7.7221B359PSRISPACS6PRU720
Single use: no
On the market
RamSoft 6.0.7.7221
Ramsoft Inc
6.0.7.7221B359PSPACS6PRU720
Single use: no
On the market
RamSoft 6.0.8.8111
Ramsoft Inc
6.0.8.8111B359PSPACS6PRU80
Single use: no
On the market
RamSoft 6.0.8.8111
Ramsoft Inc
6.0.8.8111B359GWY6PRU80
Single use: no
On the market
RamSoft 6.0.8.8111
Ramsoft Inc
6.0.8.8111B359PSRISPACS6PRU80
Single use: no
On the market
RamSoft 6.0.9.9060
Ramsoft Inc
6.0.9.9060B359GWR6PRU90
Single use: no
On the market
RamSoft 6.0.9.9060
Ramsoft Inc
6.0.9.9060B359PSPACS6PRU90
Single use: no
On the market
RamSoft 6.0.9.9060
Ramsoft Inc
6.0.9.9060B359PSRISPACS6PRU90
Single use: no
On the market
RamSoft 6.0.9.9060
Ramsoft Inc
6.0.9.9060B359GWY6PRU90
Single use: no
On the market
RamSoft 6.0.9.9061
Ramsoft Inc
6.0.9.9061B359GWR6PRU9GA0
Single use: no
On the market
RamSoft 6.0.9.9061
Ramsoft Inc
6.0.9.9061B359PSRISPACS6PRU9GA0
Single use: no
On the market
RamSoft 6.0.9.9061
Ramsoft Inc
6.0.9.9061B359GWY6PRU9GA0
Single use: no
On the market
RamSoft 6.0.9.9061
Ramsoft Inc
6.0.9.9061B359PSPACS6PRU9GA0
Single use: yes
On the market
RamSoft 6.0.9.9110
Ramsoft Inc
6.0.9.9110B359PSRISPACS6PRU910
Single use: no
On the market
RamSoft 6.0.9.9110
Ramsoft Inc
6.0.9.9110B359GWY6PRU910
Single use: no
On the market
RamSoft 6.0.9.9110
Ramsoft Inc
6.0.9.9110B359GWR6PRU91
Single use: no
On the market
RamSoft 6.0.9.9110
Ramsoft Inc
6.0.9.9110B359PSPACS6PRU910
Single use: no
On the market
RamSoft 6.7.0.49
Ramsoft Inc
6.7.0.49B359PSPACS670
Single use: no
On the market
RamSoft 6.7.0.49
Ramsoft Inc
6.7.0.49B359PSGWY670
Single use: no
On the market
RamSoft 6.7.0.49
Ramsoft Inc
6.7.0.49B359PSRISPACS670
Single use: no
On the market

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