RamSoft

Primary DI
B359PSPACS6PRU11B0
Brand
RamSoft
Company
Ramsoft Inc
Model
6.0.11.11031B
Catalog number
PSPACS6PRU11B
Device description
RamSoft PACS is a stand-alone software package that is used on general purpose computing hardware. As long as minimum hardware requirements are met, the user or system integrator is free to choose his/her own hardware platform. The software allows digital image processing, measurement, communication. and storage. RamSoft PACS is tested according to the specifications that are documented in a RamSoft PACS System Test Plan. Testing is an integral part of RamSoft's software development process. The software does not contact the patient, nor does it control any life-sustaining devices. A physician has ample opportunity for competent human intervention while interpreting images and clinical information.
Published
2024-09-09
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
B359PSPACS6PRU11B0PrimaryHIBCC0

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).

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
B359PSGWY670RamSoft6.7.0.492026-01-30
B359OAIIV2026011Ramsoft202601OAIIV2026012026-01-19
B359OAIIV2025101RamSoft202510OAIIV2025102025-10-24
B359OAIIV2025071RamSoft202507OAIIV2025072025-08-11
B359OAIIV2025051RamSoft202505OAIIV2025052025-05-12
B359OAIIV2024111RamSoft202411OAIIV2024112024-11-06
B359PSGWY6PRU11B0RamSoft6.0.11.11031BPSGWY6PRU11B2024-09-10
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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