OrthoScan TAU Mini C-Arm

Image-intensified Fluoroscopic X-ray System, Mobile

Orthoscan, Inc.

The following data is part of a premarket notification filed by Orthoscan, Inc. with the FDA for Orthoscan Tau Mini C-arm.

Pre-market Notification Details

Device IDK183220
510k NumberK183220
Device Name:OrthoScan TAU Mini C-Arm
ClassificationImage-intensified Fluoroscopic X-ray System, Mobile
Applicant Orthoscan, Inc. 14555 N. 82nd St. Scottsdale,  AZ  85260
ContactRichard Westrich
CorrespondentSteve D Seeman
Orthoscan, Inc. 14555 N. 82nd St. Scottsdale,  AZ  85260
Product CodeOXO  
Subsequent Product CodeJAA
Subsequent Product CodeMQB
CFR Regulation Number892.1650 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-11-20
Decision Date2019-06-21

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
B225100000170 K183220 000
B225100000160 K183220 000
B225100000150 K183220 000

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