Cleared Special

K153583 - BioVision Plus

K153583 is an FDA 510(k) clearance for BioVision Plus, manufactured by Faxitron Bioptics, LLC. The device is a Class 2 Radiology device with product code MWP cleared through the Special 510(k) pathway after a 108-day FDA review.

K153583 · Faxitron Bioptics, LLC · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2016
Decision
108d
Days
Class 2
Risk

K153583 is an FDA 510(k) clearance for the BioVision Plus. 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 April 1, 2016 after a review of 108 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K153583

510(k) Number K153583 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 15, 2015
Decision Date April 01, 2016
Days to Decision 108 days
Submission Type Special
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
1d slower than avg
Panel avg: 107d · This submission: 108d
Pathway characteristics
Modification to existing cleared device.

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 26
Devices cleared under the same product code (MWP) and FDA review panel - the closest regulatory comparables to K153583.
Trident HD Specimen Radiography System
K182727 · Hologic, Inc. · Jan 2019
Faxitron VisionCT
K173309 · Faxitron Bioptics, LLC · May 2018
Faxitron Bioptics Speciemen Radiography System
K170786 · Faxitron Bioptics, LLC · Jul 2017
FAXITRON SPECIEN RADIOGRAPHY SYSTEM
K122428 · Faxitron Bioptics, LLC · Sep 2012
TRIDENT SPECIMEN RADIOGRAPHY SYSTEM, MODEL : RC TRI-00001
K111508 · Hologic, Inc. · Aug 2011
10 X 10 VISION
K091928 · Bioptics, Inc. · Jun 2010
K153583 · BioVision Plus
Download PDF FDA Summary Faxitron Bioptics, LLC