FDA UDI In Commercial Distribution 🇺🇸 United States

PACS Scan Mobile

DI: 00850677007143 · Model: 3.0 · HYLAND LLC
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
PACS Scan Mobile
Primary DI
00850677007143
Version / Model
3.0
Catalog Number
PSM3.0
Company Name
HYLAND LLC
Labeler DUNS
079941872
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2019-08-30
Public Version
1
Public Version Date
2019-09-09
Public Version Status
New
Public Device Record Key
231a96c3-9223-4b0a-9f88-ef083d67dc7c

Device 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.

Device Characteristics

Single Use
No
Prescription Use (Rx)
No
Over the Counter (OTC)
No
Kit
No
Combination Product
No
HCT/P
No
Contains NRL
No
Not Made with NRL
No
MRI Safety
Labeling does not contain MRI Safety Information
Direct Marking Exempt
No
PM Exempt
Yes
Has Serial Number
Yes
Has Lot/Batch Number
No
Has Manufacturing Date
Yes
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
FXN Tape, Camera, Surgical
LMD System, Digital Image Communications, Radiological

GMDN Terms

Code Name
60702 Clinical information system web-based application software

Identifiers

Type ID
Primary 00850677007143