Cleared Traditional

K141293 - PHOT-X IIS MODEL 505

K141293 is an FDA 510(k) clearance for PHOT-X IIS MODEL 505, manufactured by Takara Belmont Corporation. The device is a Class 2 Radiology device with product code EHD cleared through the Traditional 510(k) pathway after a 107-day FDA review.

K141293 · Takara Belmont Corporation · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2014
Decision
107d
Days
Class 2
Risk

K141293 is an FDA 510(k) clearance for the PHOT-X IIS MODEL 505. Classified as Unit, X-ray, Extraoral With Timer (product code EHD), Class II - Special Controls.

Submitted by Takara Belmont Corporation (West Caldwell, US). The FDA issued a Cleared decision on September 3, 2014 after a review of 107 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 872.1800 - 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 - K141293

510(k) Number K141293 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 19, 2014
Decision Date September 03, 2014
Days to Decision 107 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
At panel average
Panel avg: 107d · This submission: 107d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EHD Device Classification - Class 2, Special Controls

Product Code EHD Unit, X-ray, Extraoral With Timer
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 - EHD Unit, X-ray, Extraoral With Timer

All 175
Devices cleared under the same product code (EHD) and FDA review panel - the closest regulatory comparables to K141293.
EzRay Air (Model VEX-P300)
K161063 · VATECH Co., Ltd. · Sep 2016
BI IMAGE-X EVOLUTION
K160458 · Radiotecnologia Industrial S.A. DE C.V. · Jun 2016
Portable X-ray System (Model: MINIX-V / MINIX-S)
K152859 · Digimed Co., Ltd. (Digimed Corporation Until 31/12/2012) · Dec 2015
PORTABLE X-RAY SYSTEM (MODEL:EXARO,XRAY2GO)
K141497 · Osstem Implant Co., Ltd. · Aug 2014
X-MIND UNITY
K132378 · De Gotzen S.R.L. · May 2014
ENDOGRAPH DC
K130109 · Villa Sistemi Medicali S.P.A. · Aug 2013