Cleared Special

K121400 - PAX-UNI3D, PHT-7500

K121400 is an FDA 510(k) clearance for PAX-UNI3D, manufactured by VATECH Co., Ltd.. The device is a Class 2 Radiology device with product code OAS cleared through the Special 510(k) pathway after a 110-day FDA review.

K121400 · VATECH Co., Ltd. · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2012
Decision
110d
Days
Class 2
Risk

K121400 is an FDA 510(k) clearance for the PAX-UNI3D, PHT-7500. Classified as X-ray, Tomography, Computed, Dental (product code OAS), Class II - Special Controls.

Submitted by VATECH Co., Ltd. (Houston, US). The FDA issued a Cleared decision on August 28, 2012 after a review of 110 days - within the typical 510(k) review window.

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. Standard predicate reliance. 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 - K121400

510(k) Number K121400 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 10, 2012
Decision Date August 28, 2012
Days to Decision 110 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
3d slower than avg
Panel avg: 107d · This submission: 110d
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 134
Devices cleared under the same product code (OAS) and FDA review panel - the closest regulatory comparables to K121400.
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CLARISCT
K120753 · Icrco, Inc. · Jul 2012
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K121412 · VATECH Co., Ltd. · Jun 2012
PAX-DUO3D PLUS, PCT-5000
K121236 · VATECH Co., Ltd. · May 2012
K121400 · PAX-UNI3D, PHT-7500
Download PDF FDA Summary VATECH Co., Ltd.