Cleared Traditional

K091558 - BIOVISION DIGITAL SPECIMEN RADIOGRAPHY SYSTEM

K091558 is an FDA 510(k) clearance for BIOVISION DIGITAL SPECIMEN RADIOGRAPHY ..., manufactured by Bioptics, Inc.. The device is a Class 2 Radiology device with product code MWP cleared through the Traditional 510(k) pathway after a 50-day FDA review.

K091558 · Bioptics, Inc. · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2009
Decision
50d
Days
Class 2
Risk

K091558 is an FDA 510(k) clearance for the BIOVISION DIGITAL SPECIMEN RADIOGRAPHY SYSTEM. Classified as Cabinet, X-ray System (product code MWP), Class II - Special Controls.

Submitted by Bioptics, Inc. (Tucson, US). The FDA issued a Cleared decision on July 17, 2009 after a review of 50 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K091558

510(k) Number K091558 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 28, 2009
Decision Date July 17, 2009
Days to Decision 50 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
57d faster than avg
Panel avg: 107d · This submission: 50d
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 25
Devices cleared under the same product code (MWP) and FDA review panel - the closest regulatory comparables to K091558.
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
CORE VISION DIGITAL SPECIMEN RADIOGRAPHY (DSR) SYSTEM
K082432 · Bioptics, Inc. · Nov 2008
FAXITRON SPECIMEN RADIOGRAPHY SYSTEM, MODEL MX-20
K072557 · Faxitron X-Ray Corp. · Oct 2007
XPERT 40 SPECIMEN RADIOGRAPHY SYSTEM
K071233 · Kub Technologies, Inc. · Jun 2007
K091558 · BIOVISION DIGITAL SPECIMEN RADIOGRAPHY SYSTEM
Download PDF FDA Summary Bioptics, Inc.