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RamSoft

FDA UDI

Class II (US FDA UDI)

by Ramsoft Inc

Identity

Trade Name
RamSoft FDA UDI
Generic Name
Radiological PACS software FDA UDI
Device Name
RamSoft PowerServer RIS/PACS 6 FDA UDI
Model / Reference
6.0.5.5100 FDA UDI
Description
RamSoft PowerServer RIS/PACS 6 FDA UDI

Identifiers

Primary DI / UDI-DI
B359PSRISPACS6PRU510 FDA UDI
510(k) Number
K052460 FDA UDI
FDA Product Code
LLZ FDA UDI
GMDN Term
Radiological PACS software FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
892.2050 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Radiological PACS softwareRadiology picture archiving and communication system workstationRadiology information systemRadiology information system application software

RamSoft by Ramsoft Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Radiology information system application software.

Cleared under the same submission

K052460 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Ramsoft Inc

Sources (1)

  • FDA UDI dcd7714b-0aad-46a7-b5a3-9c7988294381 34 fields · synced May 29, 2026