Cleared Traditional

K082432 - CORE VISION DIGITAL SPECIMEN RADIOGRAPHY (DSR) SYSTEM

K082432 is an FDA 510(k) clearance for CORE VISION DIGITAL SPECIMEN RADIOGRAPH..., 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 91-day FDA review.

K082432 · Bioptics, Inc. · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2008
Decision
91d
Days
Class 2
Risk

K082432 is an FDA 510(k) clearance for the CORE VISION DIGITAL SPECIMEN RADIOGRAPHY (DSR) SYSTEM. Classified as Cabinet, X-ray System (product code MWP), Class II - Special Controls.

Submitted by Bioptics, Inc. (Surprise, US). The FDA issued a Cleared decision on November 21, 2008 after a review of 91 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.

FDA 510(k) Submission Details - K082432

510(k) Number K082432 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 22, 2008
Decision Date November 21, 2008
Days to Decision 91 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
16d faster than avg
Panel avg: 107d · This submission: 91d
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 K082432.
TRIDENT SPECIMEN RADIOGRAPHY SYSTEM, MODEL : RC TRI-00001
K111508 · Hologic, Inc. · Aug 2011
10 X 10 VISION
K091928 · Bioptics, Inc. · Jun 2010
BIOVISION DIGITAL SPECIMEN RADIOGRAPHY SYSTEM
K091558 · Bioptics, Inc. · Jul 2009
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
FAXITRON DIGITAL RADIOGRAPHY SYSTEM, MODEL DX-50
K061361 · Faxitron X-Ray Corp. · Aug 2006
K082432 · CORE VISION DIGITAL SPECIMEN RADIOGRAPHY (DSR) SYSTEM
Download PDF FDA Summary Bioptics, Inc.