Cleared Traditional

K172863 - Infinix-i

K172863 is the FDA 510(k) clearance for Infinix-i by Toshibamedical Systems Corporation. It is a Class 2 Radiology device (product code OWB) cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K172863 · Toshibamedical Systems Corporation · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2017
Decision
85d
Days
Class 2
Risk

K172863 is an FDA 510(k) clearance for the Infinix-i, INFX-8000V, V7.0. Classified as Interventional Fluoroscopic X-ray System (product code OWB), Class II - Special Controls.

Submitted by Toshibamedical Systems Corporation (Otawara-Shi, JP). The FDA issued a Cleared decision on December 14, 2017 after a review of 85 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Toshibamedical Systems Corporation devices

Submission Details

510(k) Number K172863 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 20, 2017
Decision Date December 14, 2017
Days to Decision 85 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
22d faster than avg
Panel avg: 107d · This submission: 85d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OWB Interventional Fluoroscopic X-ray System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1650
Definition Interventional Fluoroscopy
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 Consultant

Toshiba America Medical Systems, In.C
Janine F. Reyes

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - OWB Interventional Fluoroscopic X-ray System

All 240
Devices cleared under the same product code (OWB) and FDA review panel - the closest regulatory comparables to K172863.
OSCAR 15
K172180 · Genoray Co., Ltd. · Feb 2018
ProxiDiagnost N90
K173433 · Philips Medical Systems Dmc GmbH · Feb 2018
Medtronic O-arm O2 Imaging System
K173664 · Medtronic, Inc. · Dec 2017
Azurion series R1.2
K172822 · Philips Medical Systems Nederland B.V. · Nov 2017
LessRay System
K173314 · Nu Vasive, Incorporated · Nov 2017
XIDF-AWS801, Angio Workstation, V7.0
K172646 · Toshibamedical Systems Corporation · Oct 2017