FDA.reportPublic FDA data

RamSoft

Primary DI
B359PSPACS0
Brand
RamSoft
Company
Ramsoft Inc
Model
6.0.11.11031A
Catalog number
PSPACS6
Device description
PowerServer is a scalable storage and distribution system for clinical images and data. Images can be stored in lossless or lossy formats. The system is DICOM compliant for image storage, archiving, retrieval, and transmission, and communicates with other DICOM devices. The system also communicates with PowerReader workstations and PowerCache servers. Acquired image data is preserved as captured and changes to display definitions are saved as presentation states so that images may always be reverted back to their initial state. PowerCache is a caching server that communicates with PowerServer and serves PowerReader workstations. A single PowerCache can serve multiple PowerReader workstations, reducing network traffic between PowerReader workstations and PowerServer. PowerReader is a workstation that views, edits, manipulates, annotates, analyzes, stores, and distributes images and data stored on PowerServer and PowerCache. PowerReader can connect directly to PowerServer and can also connect via PowerCache. PowerReader provides the user with the ability to import, transmit, print, display, store, edit, and process medical images and data. 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
2024-05-08
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
B359PSPACS0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Radiology information systemA dedicated computerized radiology information system (RIS) designed to electronically receive, collect, store, manage, assist in analysis of, display, output, and distribute data, within or between healthcare facilities, to support the administrative and clinical activities associated with the provision and utilization of radiology services and facilities. It may be used for patient scheduling and generation of work lists for specific radiological systems, and in conjunction with a picture archiving and communication system (PACS). The system consists of dedicated combined hardware (e.g., computers, terminals, network components) and software (typically embedded).

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
B359PSGWY670RamSoft6.7.0.492026-01-30
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
B359PSRISPACS0RamSoft6.0.11.11031APSRISPACS62024-05-08
B359OAIIVV31RamSoft3.0OMEGAAIIV032024-05-03
B359GWR6PRU9GA0RamSoft6.0.9.90612019-07-22

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