Cleared Special

K093453 - MODIFICATION TO COMPUTED ORAL RADIOLOGY SYSTEM

K093453 is an FDA 510(k) clearance for MODIFICATION TO COMPUTED ORAL RADIOLOGY..., manufactured by Schick Technologies, Inc.. The device is a Class 2 Radiology device with product code EAP cleared through the Special 510(k) pathway after a 25-day FDA review.

K093453 · Schick Technologies, Inc. · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2009
Decision
25d
Days
Class 2
Risk

K093453 is an FDA 510(k) clearance for the MODIFICATION TO COMPUTED ORAL RADIOLOGY SYSTEM. Classified as Unit, X-ray, Intraoral (product code EAP), Class II - Special Controls.

Submitted by Schick Technologies, Inc. (Long Island City, US). The FDA issued a Cleared decision on November 30, 2009 after a review of 25 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 872.1810 - 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. Low regulatory complexity profile. 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 - K093453

510(k) Number K093453 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 05, 2009
Decision Date November 30, 2009
Days to Decision 25 days
Submission Type Special
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
82d faster than avg
Panel avg: 107d · This submission: 25d
Pathway characteristics
Modification to existing cleared device.

EAP Device Classification - Class 2, Special Controls

Product Code EAP Unit, X-ray, Intraoral
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.1810
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 - EAP Unit, X-ray, Intraoral

All 29
Devices cleared under the same product code (EAP) and FDA review panel - the closest regulatory comparables to K093453.
MEDICAL IMAGE PROCESSING UNIT
K113360 · Humanray Co,Ltd · Feb 2012
PROVU (TM) DENTAL X-RAY SYSTEM
K102573 · Advanced Image Science, Inc. · Jun 2011
DENTRON SENSOR
K080738 · Dentron Systems, LLC · May 2008
THE ENVISION INTRAORAL DENTAL X-RAY MACHINES (WALL MOUNTED AND MOBILE)
K052422 · Flow X-Ray Corp. · Sep 2005
MODIFICATION TO COMPUTED ORAL RADIOLOGY SYSTEM
K041385 · Schick Technologies, Inc. · Jun 2004
HELIODENT DS
K960819 · Pelton & Crane Co. · Mar 1996
K093453 · MODIFICATION TO COMPUTED ORAL RADIOLOGY SYSTEM
Download PDF FDA Summary Schick Technologies, …