PACS Scan Mobile PSM3.0

GUDID 00850677007143

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.

HYLAND LLC

Clinical information system web-based application software

• Primary Device ID: 00850677007143
• NIH Device Record Key: 231a96c3-9223-4b0a-9f88-ef083d67dc7c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PACS Scan Mobile
• Version Model Number: 3.0
• Catalog Number: PSM3.0
• Company DUNS: 079941872
• Company Name: HYLAND LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850677007143 [Primary]

FDA Product Code

• FXN: Tape, Camera, Surgical

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-09-09
• Device Publish Date: 2019-08-30

On-Brand Devices [PACS Scan Mobile]

• 00850677007150: PACS Scan Mobile, Android
• 00850677007143: The PACS Scan Mobile client is an application for mobile devices that can used to easily capture