Cleared Traditional

K183142 - PathVisionXL

K183142 is an FDA 510(k) clearance for PathVisionXL, manufactured by Faxitron Bioptics, LLC. The device is a Class 2 Radiology device with product code MWP cleared through the Traditional 510(k) pathway after a 121-day FDA review.

K183142 · Faxitron Bioptics, LLC · Radiology device
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Mar 2019
Decision
121d
Days
Class 2
Risk

K183142 is an FDA 510(k) clearance for the PathVisionXL. Classified as Cabinet, X-ray System (product code MWP), Class II - Special Controls.

Submitted by Faxitron Bioptics, LLC (Tucson, US). The FDA issued a Cleared decision on March 14, 2019 after a review of 121 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1680 - 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 Faxitron Bioptics, LLC devices

FDA 510(k) Submission Details - K183142

510(k) Number K183142 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 2018
Decision Date March 14, 2019
Days to Decision 121 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
14d slower than avg
Panel avg: 107d · This submission: 121d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MWP Device Classification - Class 2, Special Controls

Product Code MWP Cabinet, X-ray System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1680
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 - MWP Cabinet, X-ray System

All 22
Devices cleared under the same product code (MWP) and FDA review panel - the closest regulatory comparables to K183142.
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Trident HD Specimen Radiography System
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Faxitron VisionCT
K173309 · Faxitron Bioptics, LLC · May 2018
Faxitron Bioptics Speciemen Radiography System
K170786 · Faxitron Bioptics, LLC · Jul 2017