Cleared Special

K052422 - THE ENVISION INTRAORAL DENTAL X-RAY MACHINES (WALL MOUNTED AND MOBILE)

K052422 is an FDA 510(k) clearance for THE ENVISION INTRAORAL DENTAL X-RAY MAC..., manufactured by Flow X-Ray Corp.. 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.

K052422 · Flow X-Ray Corp. · Radiology device
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Optimized for regulatory review, auditing and printing
Sep 2005
Decision
25d
Days
Class 2
Risk

K052422 is an FDA 510(k) clearance for the THE ENVISION INTRAORAL DENTAL X-RAY MACHINES (WALL MOUNTED AND MOBILE). Classified as Unit, X-ray, Intraoral (product code EAP), Class II - Special Controls.

Submitted by Flow X-Ray Corp. (Great Neck, US). The FDA issued a Cleared decision on September 27, 2005 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.

View all Flow X-Ray Corp. devices

FDA 510(k) Submission Details - K052422

510(k) Number K052422 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 02, 2005
Decision Date September 27, 2005
Days to Decision 25 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
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 13
Devices cleared under the same product code (EAP) and FDA review panel - the closest regulatory comparables to K052422.
MEDICAL IMAGE PROCESSING UNIT
K113360 · Humanray Co,Ltd · Feb 2012
MODIFICATION TO COMPUTED ORAL RADIOLOGY SYSTEM
K093453 · Schick Technologies, Inc. · Nov 2009
DENTRON SENSOR
K080738 · Dentron Systems, LLC · May 2008
MODIFICATION TO COMPUTED ORAL RADIOLOGY SYSTEM
K041385 · Schick Technologies, Inc. · Jun 2004
HELIODENT DS
K960819 · Pelton & Crane Co. · Mar 1996
ORTHORALIX SD2 & S PANORAMIC DENTAL X-RAY SYSTEM
K960028 · Dentsply Intl. · Mar 1996