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Radiology Information Systems, Inc.

FDA UDI

Class I (US FDA UDI)

by Radiology Information Systems, Inc.

Identity

Trade Name
Radiology Information Systems, Inc. FDA UDI
Generic Name
Radiological PACS software FDA UDI
Device Name
For use as a storage and display node on a DICOM 3.0 Network. It can receive, store, transmit and display images as a PACS application. In addition it can merge information from its keyboard with bitmap images from imaging devices to create DICOM 3.0 image files FDA UDI
Model / Reference
RSVS FDA UDI
Description
For use as a storage and display node on a DICOM 3.0 Network. It can receive, store, transmit and display images as a PACS application. In addition it can merge information from its keyboard with bitmap images from imaging devices to create DICOM 3.0 image files FDA UDI

Identifiers

Primary DI / UDI-DI
00860009490642 FDA UDI
FDA Product Code
LMD FDA UDI
GMDN Term
Radiological PACS software FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
892.2020 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Radiological PACS softwareRadiology picture archiving and communication system digital archive device

Radiology Information Systems, Inc. by Radiology Information Systems, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Radiology picture archiving and communication system digital archive device.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Radiology Information Systems, Inc.

Sources (1)

  • FDA UDI 44096562-de8a-42f6-b305-725b10e3ae7a 33 fields · synced Jun 6, 2026