DEVICE: PACS Scan Mobile (00850677007143)
Device Identifier (DI) Information
PACS Scan Mobile
3.0
In Commercial Distribution
PSM3.0
HYLAND LLC
3.0
In Commercial Distribution
PSM3.0
HYLAND LLC
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
Labeling does not contain MRI Safety Information | |
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No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
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60702 | Clinical information system web-based application software |
An application software program designed as an Internet-based information system to support the administrative, clinical, and quality control activities associated with the provision/utilization of healthcare within a specific clinical specialty (e.g., orthopaedics, general surgery, neurology, ophthalmology, oncology, rheumatology, dermatology). It can be available on any web-enabled interface (including mobile devices at point-of-care) and is intended for use by healthcare professionals in a clinical setting.
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Obsolete | false |
FDA Product Code
[?]Product Code | Product Code Name |
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FXN | Tape, Camera, Surgical |
LMD | System, Digital Image Communications, Radiological |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
231a96c3-9223-4b0a-9f88-ef083d67dc7c
September 09, 2019
1
August 30, 2019
September 09, 2019
1
August 30, 2019
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined