Cleared Special

K122606 - PHT-6500

Also marketed or referenced as:
PHT-60CFO PAX-I3D

K122606 is an FDA 510(k) clearance for PHT-6500, manufactured by Mtechgroup. The device is a Class 2 Radiology device with product code OAS cleared through the Special 510(k) pathway after a 85-day FDA review.

K122606 · Mtechgroup · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2012
Decision
85d
Days
Class 2
Risk

K122606 is an FDA 510(k) clearance for the PHT-6500. Classified as X-ray, Tomography, Computed, Dental (product code OAS), Class II - Special Controls.

Submitted by Mtechgroup (Houston, US). The FDA issued a Cleared decision on November 20, 2012 after a review of 85 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1750 - 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 Mtechgroup devices

FDA 510(k) Submission Details - K122606

510(k) Number K122606 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 27, 2012
Decision Date November 20, 2012
Days to Decision 85 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
22d faster than avg
Panel avg: 107d · This submission: 85d
Pathway characteristics
Modification to existing cleared device.

OAS Device Classification - Class 2, Special Controls

Product Code OAS X-ray, Tomography, Computed, Dental
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1750
Definition Produce Cross-sectional Diagnostic X-ray Images Of The Intra-oral Tissue And Teeth.
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 - OAS X-ray, Tomography, Computed, Dental

All 99
Devices cleared under the same product code (OAS) and FDA review panel - the closest regulatory comparables to K122606.
HYPERION X9
K123381 · Cefla S.C. · May 2013
GALILEOS FAMILY
K123070 · Sirona Dental Systems GmbH · Mar 2013
RAYSCAN A-EXPERT 3D
K122981 · Ray Co., Ltd. · Mar 2013
PAX-UNI3D, PHT-7500
K121400 · VATECH Co., Ltd. · Aug 2012
PAX-FLEX3D, PHT-7000
K121412 · VATECH Co., Ltd. · Jun 2012
PAX-DUO3D PLUS, PCT-5000
K121236 · VATECH Co., Ltd. · May 2012