Cleared Traditional

K183220 - OrthoScan TAU Mini C-Arm

K183220 is an FDA 510(k) clearance for OrthoScan TAU Mini C-Arm, manufactured by Orthoscan, Inc.. The device is a Class 2 Radiology device with product code OXO cleared through the Traditional 510(k) pathway after a 213-day FDA review.

K183220 · Orthoscan, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2019
Decision
213d
Days
Class 2
Risk

K183220 is an FDA 510(k) clearance for the OrthoScan TAU Mini C-Arm. Classified as Image-intensified Fluoroscopic X-ray System, Mobile (product code OXO), Class II - Special Controls.

Submitted by Orthoscan, Inc. (Scottsdale, US). The FDA issued a Cleared decision on June 21, 2019 after a review of 213 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1650 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Orthoscan, Inc. devices

FDA 510(k) Submission Details - K183220

510(k) Number K183220 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 20, 2018
Decision Date June 21, 2019
Days to Decision 213 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
106d slower than avg
Panel avg: 107d · This submission: 213d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

OXO Device Classification - Class 2, Special Controls

Product Code OXO Image-intensified Fluoroscopic X-ray System, Mobile
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1650
Definition Fluoroscopy Of The Human Body.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - OXO Image-intensified Fluoroscopic X-ray System, Mobile

All 38
Devices cleared under the same product code (OXO) and FDA review panel - the closest regulatory comparables to K183220.
OEC 3D
K203346 · Ge Oec Medical Systems, Inc. · Mar 2021
OEC Elite
K192819 · Ge Oec Medical Systems, Inc. · Nov 2019
Smart-C
K190024 · Turner Imaging Systems, Inc. · Sep 2019
OEC One
K182626 · Ge Hualun Medical Systems Co. , Ltd. · Nov 2018
INSIGHT - FD MINI C-ARM FLUOROSCOPIC IMAGING SYSTEM
K120388 · Hologic, Inc. · Apr 2012
VERT-X
K061873 · Direx Systems Corp. · Aug 2006