Cleared Special

K121132 - EZSENSOR P DIGITAL INTRAORAL SENSOR

K121132 is an FDA 510(k) clearance for EZSENSOR P DIGITAL INTRAORAL SENSOR, manufactured by Humanray Co,Ltd. The device is a Class 2 Radiology device with product code MQB cleared through the Special 510(k) pathway after a 27-day FDA review.

K121132 · Humanray Co,Ltd · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2012
Decision
27d
Days
Class 2
Risk

K121132 is an FDA 510(k) clearance for the EZSENSOR P DIGITAL INTRAORAL SENSOR. Classified as Solid State X-ray Imager (flat Panel/digital Imager) (product code MQB), Class II - Special Controls.

Submitted by Humanray Co,Ltd (Houston, US). The FDA issued a Cleared decision on May 10, 2012 after a review of 27 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. 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 - K121132

510(k) Number K121132 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 13, 2012
Decision Date May 10, 2012
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.

MQB Device Classification - Class 2, Special Controls

Product Code MQB Solid State X-ray Imager (flat Panel/digital Imager)
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 - MQB Solid State X-ray Imager (flat Panel/digital Imager)

All 423
Devices cleared under the same product code (MQB) and FDA review panel - the closest regulatory comparables to K121132.
LIEBEL-FLARSHEIM DIRECT DIGITAL IMAGING SYSTEM
K121838 · Liebel-Flarsheim · Jul 2012
FUSION FLAT PANEL
K113449 · Icrco, Inc. · Jun 2012
UNIVERSAL DIGITAL INTERFACE (UDI) 1717
K112527 · Meridian Medical Systems, LLC · May 2012
VIVIX-S
K120020 · Vieworks Co., Ltd. · May 2012
ATAL-8
K113812 · Atlaim · May 2012
FLAT PANEL DETECTOR
K111824 · Canon Inc. -Medical Equipment Group · Apr 2012
K121132 · EZSENSOR P DIGITAL INTRAORAL SENSOR
Download PDF FDA Summary Humanray Co,Ltd