FDA.reportPublic FDA data

RamSoft

Primary DI
B359PSGWY670
Brand
RamSoft
Company
Ramsoft Inc
Model
6.7.0.49
Device description
Gateway is a stand-alone DICOM compliant workstation that views, edits, manipulates, annotates, analyzes, stores, and distributes images and data. Gateway provides the user with the ability to import, transmit, print, display, store, edit, and process medical images and data.
Published
2026-01-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
LLZSystem, Image Processing, Radiological

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LLZSystem, Image Processing, RadiologicalRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K052460000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K052460000POWERSERVER, POWERREADER, GATEWAY AND POWERCACHERamsoft, Inc.2005-09-21LLZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B359PSGWY670PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Radiological PACS softwareAn individual software application intended to be installed on a central server as part of a picture archiving and communication system (PACS) to allow storage, retrieval, analysis, and management of radiological images.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
255320228
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B359OAIIV2026051Ramsoft202605OAIIV2026052026-06-04
B359PSPACS670RamSoft6.7.0.492026-01-30
B359PSRISPACS670RamSoft6.7.0.492026-01-30
B359OAIIV2026031Ramsoft202603OAIIV2026032026-04-01
B359OAIIV2026011Ramsoft202601OAIIV2026012026-01-19
B359OAIIV2025101RamSoft202510OAIIV2025102025-10-24
B359OAIIV2025071RamSoft202507OAIIV2025072025-08-11
B359OAIIV2025051RamSoft202505OAIIV2025052025-05-12
B359OAIIV2024111RamSoft202411OAIIV2024112024-11-06
B359PSGWY6PRU11B0RamSoft6.0.11.11031BPSGWY6PRU11B2024-09-10
B359PSPACS6PRU11B0RamSoft6.0.11.11031BPSPACS6PRU11B2024-09-09
B359PSRISPACS6PRU11B0RamSoft6.0.11.11031BPSRISPACS6PRU11B2024-09-09
B359OAIIV2024081RamSoft202408OAIIV2024082024-09-06
B359OAIIV2024071RamSoft202407OAIIV2024072024-07-30
B359PSGWY6PRU11A0RamSoft6.0.11.11031A2024-05-08
B359PSPACS0RamSoft6.0.11.11031APSPACS62024-05-08
B359PSRISPACS0RamSoft6.0.11.11031APSRISPACS62024-05-08
B359OAIIVV31RamSoft3.0OMEGAAIIV032024-05-03
B359GWR6PRU9GA0RamSoft6.0.9.90612019-07-22
B359GWY6PRU9GA0RamSoft6.0.9.90612019-07-22

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