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
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

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-dedicated management softwareA software program dedicated for installation on a central server as part of a picture archiving and communication system (PACS) to allow storage, retrieval, analysis, and management of a broad range of radiological images throughout the healthcare system. As a PACS-dedicated software, it is not primarily intended for diagnosis support, triage, or treatment planning. It does not incorporate adaptive/dynamic machine learning (ML) models.

Regulatory Flags#

DUNS number
255320228
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B359OAIIV2026071RamSoft202607OAIIV2026072026-08-17
B359OAIIV2026051Ramsoft202605OAIIV2026052026-06-04
B359OAIIV2025101RamSoft202510OAIIV2025102025-10-24
B359OAIIV2026031Ramsoft202603OAIIV2026032026-04-01
B359PSPACS670RamSoft6.7.0.492026-01-30
B359PSRISPACS670RamSoft6.7.0.492026-01-30
B359OAIIV2026011Ramsoft202601OAIIV2026012026-01-19
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

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Primary DI, Brand, Company table
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TKRL0001F7940PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
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TKRL0001F9F00PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
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TKRL000203ID0PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
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TKRL0002066I0PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL000207330PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL000208K50PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL0002098I0PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL000209F30PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL00020D0F0PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL00020F080PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL00020F670PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL00020I510PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20