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510(k) Data Aggregation
K Number
K202713Device Name
TrueView 100 Pro
Manufacturer
CompAI Healthcare (Shenzhen) Co.,ltd
Date Cleared
2020-11-18
(63 days)
Product Code
MWP
Regulation Number
892.1680Why did this record match?
Applicant Name (Manufacturer) :
CompAI Healthcare (Shenzhen) Co.,ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
A cabinet X-ray system used to provide digital X-ray images of surgical and core biopsy specimens from various anatomical regions in order to allow rapid verification that the correct tissue has been excised during the biopsy procedure.
Doing the verification in the same room as the procedure or nearby improves workflow, thus reducing the time the patient needs to be under examination.
Device Description
The TrueView 100 Pro is a self-contained, direct digital imaging system for imaging surgical and biopsy specimens. The TrueView 100 Pro includes the following major components: a system monitor, touch-screen display, a touchpad, and an imaging cabinet. The system is self-contained. Shielding is incorporated within the cabinet chamber system design, eliminating the need for separate shielding. The unit is mounted on casters to allow for easy transportation.
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