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PACS Scan Mobile

FDA UDI

Class I (US FDA UDI)

by Hyland Llc

Identity

Trade Name
PACS Scan Mobile FDA UDI
Generic Name
Clinical information system web-based application software FDA UDI
Device Name
The PACS Scan Mobile client is an application for mobile devices that can used to easily capture images and videos and send them to patient studies on DICOM archives. The user queries and retrieves a patient study from a worklist, or creates a new patient record. The user may then take clinical photos and/or videos to send to the patient record. Photos may be manipulated (crop and rotate) and annotated prior to sending. Videos may not be altered prior to sending. Unwanted images may be deleted prior to sending. The user may also add a series description to the study. Typical users of the PACS Scan Mobile application are trained medical professionals, including but not limited to clinicians, technologists, assistants and lay persons. PSM is not intended for diagnostic use. FDA UDI
Model / Reference
3.0 FDA UDI
Description
The PACS Scan Mobile client is an application for mobile devices that can used to easily capture images and videos and send them to patient studies on DICOM archives. The user queries and retrieves a patient study from a worklist, or creates a new patient record. The user may then take clinical photos and/or videos to send to the patient record. Photos may be manipulated (crop and rotate) and annotated prior to sending. Videos may not be altered prior to sending. Unwanted images may be deleted prior to sending. The user may also add a series description to the study. Typical users of the PACS Scan Mobile application are trained medical professionals, including but not limited to clinicians, technologists, assistants and lay persons. PSM is not intended for diagnostic use. FDA UDI

Identifiers

Catalog Number
PSM3.0 FDA UDI
Primary DI / UDI-DI
00850677007143 FDA UDI
FDA Product Code
FXN FDA UDI
LMD FDA UDI
GMDN Term
Clinical information system web-based application software FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
878.4160 FDA UDI
892.2020 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

Yes

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Clinical information system web-based application software

PACS Scan Mobile by Hyland Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Clinical information system web-based application software.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Hyland Llc

Sources (1)

  • FDA UDI 231a96c3-9223-4b0a-9f88-ef083d67dc7c 34 fields · synced May 30, 2026