Cleared Special

K022953 - MODIFICATION TO COMPUTED ORAL RADIOLOGY SYSTEM

K022953 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 MUH cleared through the Special 510(k) pathway after a 27-day FDA review.

K022953 · Schick Technologies, Inc. · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2002
Decision
27d
Days
Class 2
Risk

K022953 is an FDA 510(k) clearance for the MODIFICATION TO COMPUTED ORAL RADIOLOGY SYSTEM. Classified as System, X-ray, Extraoral Source, Digital (product code MUH), Class II - Special Controls.

Submitted by Schick Technologies, Inc. (Long Island City, US). The FDA issued a Cleared decision on October 2, 2002 after a review of 27 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 872.1800 - 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 - K022953

510(k) Number K022953 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 05, 2002
Decision Date October 02, 2002
Days to Decision 27 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
80d faster than avg
Panel avg: 107d · This submission: 27d
Pathway characteristics
Modification to existing cleared device.

MUH Device Classification - Class 2, Special Controls

Product Code MUH System, X-ray, Extraoral Source, Digital
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.1800
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 - MUH System, X-ray, Extraoral Source, Digital

All 206
Devices cleared under the same product code (MUH) and FDA review panel - the closest regulatory comparables to K022953.
CDR PANX, MODEL 4792
K031291 · Schick Technologies, Inc. · May 2003
TROPHYPAN
K023346 · Trophy Radiologie · Jan 2003
APEX HRI DIGITAL RADIOGRAPHY SYSTEM
K023292 · Krugman Technologies, Inc. · Dec 2002
INTRAORAL IMAGING SYSTEM, MODEL SUNI-RAY
K021718 · Suni Imaging Microsystems, Inc. · Aug 2002
ADC DENTAL
K021542 · Agfa Corp. · Aug 2002
X-IMAGE DIGITAL X-RAY SYSTEM
K020588 · Escape Technology, Inc. · Jun 2002
K022953 · MODIFICATION TO COMPUTED ORAL RADIOLOGY SYSTEM
Download PDF FDA Summary Schick Technologies, …