Cleared Traditional

K182546 - Alphenix

K182546 is the FDA 510(k) clearance for Alphenix by Canon Medical Systems Corporation. It is a Class 2 Radiology device (product code OWB) cleared through the Traditional 510(k) pathway after a 30-day FDA review.

K182546 · Canon Medical Systems Corporation · Radiology device
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Oct 2018
Decision
30d
Days
Class 2
Risk

K182546 is an FDA 510(k) clearance for the Alphenix, INFX-8000H/B, V8.0. Classified as Interventional Fluoroscopic X-ray System (product code OWB), Class II - Special Controls.

Submitted by Canon Medical Systems Corporation (Otawara-Shi, JP). The FDA issued a Cleared decision on October 17, 2018 after a review of 30 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 Canon Medical Systems Corporation devices

Submission Details

510(k) Number K182546 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 17, 2018
Decision Date October 17, 2018
Days to Decision 30 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
77d faster than avg
Panel avg: 107d · This submission: 30d
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

Canon Medical Systems USA, Inc.
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 239
Devices cleared under the same product code (OWB) and FDA review panel - the closest regulatory comparables to K182546.
Innova IGS 5, Innova IGS 6, Discovery IGS 7, Discovery IGS 7 OR
K181403 · Ge Healthcare · Nov 2018
Cios Spin
K181550 · Siemens Medical Solutions USA, Inc. · Oct 2018
Cios Alpha
K181560 · Siemens Medical Systems USA, Inc. · Oct 2018
Alphenix, INFX-8000F/B, V8.0
K182415 · Canon Medical Systems Corporation · Sep 2018
XIDF - AWS801, Angio Workstation (Alphenix Workstation), V8.0
K181415 · Canon Medical Systems Corporation · Sep 2018
Cios Select
K181767 · Siemens Medical Solutions USA, Inc. · Aug 2018